An observational study in Influenza, Human, sponsored by GlaxoSmithKline. Completed at 1 site in United Kingdom. Open to participants aged 6 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-11.
Sponsored by GlaxoSmithKline · Observational
The purpose of this 2016/17 pilot study is to improve the combination of a card-based adverse drug reaction (ADR) system and the use of routine data to collect adverse events following vaccination with seasonal influenza vaccines, as per European Medicines Agency (EMA) guidance and Pharmacovigilance Risk Assessment Committee of EMA (PRAC) requirements, and to identify additional data which may need to be collected in order to appropriately address the requirement.
2,264 studies on the registry are indexed under Influenza, Human; 173 are open to participants now.
This study's enrollment of 19,334 is above the median of 300 across 313 observational studies indexed under Influenza, Human.
Browse Influenza, Human studies →GlaxoSmithKline is the lead sponsor of 3,647 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 239 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Registered patients in up to 10 volunteer English general practices immunized against seasonal influenza at the beginning of 2016/17 season.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in approximately 10 volunteer practices.
Other: Vaccine safety surveillance
Volunteered subjects who received Non-GSK influenza vaccination in approximately 10 volunteer practices.
Other: Vaccine safety surveillance
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in approximately 10 volunteer practices.
Other: Vaccine safety surveillance
Extraction of routinely collected primary care data from approximately 10 volunteer English general practices by using an improved card-based ADR reporting system to estimate proportions of AEIs among seasonal influenza-vaccinated individuals.
Number of Subjects Reporting European Medical Agency (EMA) Defined Adverse Events of Interest (AEIs) (Any) & Onset Dates of AEIs Using a Card Based-adverse Drug Reaction (ADR) Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome). The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome). The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Local symptoms include local erythema. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative).
Local symptoms include local erythema. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, irritability and malaise. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, irritability and malaise. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Rash AEs include any rash AEs, generalised rash and rash. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Rash AEs include any rash AEs, generalised rash and rash. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.
Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).
Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR .
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016).
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who receive d the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR .
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016).
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
Local symptoms included local erythema. The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
Local symptoms included local erythema. The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR .
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR .
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative)
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative).
AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative).
AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Rash AEs include any rash AEs, generalised rash and rash.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)
Rash AEs include any rash AEs, generalised rash and rash.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).
Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.
Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),
Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.
Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Rash AEs include any rash AEs, generalised rash and rash.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
Rash AEs include any rash AEs, generalised rash and rash.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)
Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis
Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).
Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions.
Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)
| Milestone | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| Started | 13861 | 2295 | 3178 |
| Completed | 13861 | 2295 | 3178 |
| Not completed | 0 | 0 | 0 |
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome). The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| Week 37 | 0 |
| Week 38 | 67 |
| Week 39 | 169 |
| Week 40 | 164 |
| Week 41 | 112 |
| Week 42 | 85 |
| Week 43 | 29 |
| Week 44 | 31 |
| Week 45 | 28 |
| Week 46 | 13 |
| Week 47 | 3 |
| Week 48 | 2 |
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome). The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| Week 37 | 0 |
| Week 38 | 67 |
| Week 39 | 236 |
| Week 40 | 400 |
| Week 41 | 512 |
| Week 42 | 597 |
| Week 43 | 626 |
| Week 44 | 657 |
| Week 45 | 685 |
| Week 46 | 698 |
| Week 47 | 701 |
| Week 48 | 703 |
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| Week 37 | 0 |
| Week 38 | 4 |
| Week 39 | 15 |
| Week 40 | 8 |
| Week 41 | 10 |
| Week 42 | 9 |
| Week 43 | 3 |
| Week 44 | 2 |
| Week 45 | 3 |
| Week 46 | 4 |
| Week 47 | 0 |
| Week 48 | 0 |
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| Week 37 | 0 |
| Week 38 | 4 |
| Week 39 | 19 |
| Week 40 | 27 |
| Week 41 | 37 |
| Week 42 | 46 |
| Week 43 | 49 |
| Week 44 | 51 |
| Week 45 | 54 |
| Week 46 | 58 |
| Week 47 | 58 |
| Week 48 | 58 |
Local symptoms include local erythema. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| Week 37 | 0 |
| Week 38 | 16 |
| Week 39 | 20 |
| Week 40 | 24 |
| Week 41 | 28 |
| Week 42 | 15 |
| Week 43 | 6 |
| Week 44 | 7 |
| Week 45 | 8 |
| Week 46 | 3 |
| Week 47 | 0 |
| Week 48 | 0 |
Local symptoms include local erythema. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| Week 37 | 0 |
| Week 38 | 16 |
| Week 39 | 36 |
| Week 40 | 60 |
| Week 41 | 88 |
| Week 42 | 103 |
| Week 43 | 109 |
| Week 44 | 116 |
| Week 45 | 124 |
| Week 46 | 127 |
| Week 47 | 127 |
| Week 48 | 127 |
General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, irritability and malaise. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| Any, Week 37 | 0 |
| Any, Week 38 | 20 |
| Any, Week 39 | 47 |
| Any, Week 40 | 43 |
| Any, Week 41 | 25 |
| Any, Week 42 | 20 |
| Any, Week 43 | 3 |
| Any, Week 44 | 6 |
| Any, Week 45 | 9 |
| Any, Week 46 | 6 |
| Any, Week 47 | 2 |
| Any, Week 48 | 1 |
| Drowsiness, Week 37 | 0 |
| Drowsiness, Week 38 | 8 |
| Drowsiness, Week 39 | 20 |
| Drowsiness, Week 40 | 18 |
| Drowsiness, Week 41 | 10 |
| Drowsiness, Week 42 | 9 |
| Drowsiness, Week 43 | 1 |
| Drowsiness, Week 44 | 1 |
| Drowsiness, Week 45 | 2 |
| Drowsiness, Week 46 | 2 |
| Drowsiness, Week 47 | 1 |
| Drowsiness, Week 48 | 0 |
| Fatigue, Week 37 | 0 |
| Fatigue, Week 38 | 20 |
| Fatigue, Week 39 | 40 |
| Fatigue, Week 40 | 35 |
| Fatigue, Week 41 | 20 |
| Fatigue, Week 42 | 13 |
| Fatigue, Week 43 | 3 |
| Fatigue, Week 44 | 6 |
| Fatigue, Week 45 | 9 |
| Fatigue, Week 46 | 6 |
| Fatigue, Week 47 | 1 |
| Fatigue, Week 48 | 1 |
| Irritability, Week 37 | 0 |
| Irritability, Week 38 | 3 |
| Irritability, Week 39 | 2 |
| Irritability, Week 40 | 6 |
| Irritability, Week 41 | 1 |
| Irritability, Week 42 | 1 |
| Irritability, Week 43 | 1 |
| Irritability, Week 44 | 1 |
| Irritability, Week 45 | 1 |
| Irritability, Week 46 | 0 |
| Irritability, Week 47 | 0 |
| Irritability, Week 48 | 0 |
| Malaise, Week 37 | 0 |
| Malaise, Week 38 | 0 |
| Malaise, Week 39 | 0 |
| Malaise, Week 40 | 0 |
| Malaise, Week 41 | 0 |
| Malaise, Week 42 | 0 |
| Malaise, Week 43 | 0 |
| Malaise, Week 44 | 0 |
| Malaise, Week 45 | 0 |
| Malaise, Week 46 | 0 |
| Malaise, Week 47 | 0 |
| Malaise, Week 48 | 0 |
General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, irritability and malaise. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| Any, Week 37 | 0 |
| Any, Week 38 | 20 |
| Any, Week 39 | 67 |
| Any, Week 40 | 110 |
| Any, Week 41 | 135 |
| Any, Week 42 | 155 |
| Any, Week 43 | 158 |
| Any, Week 44 | 164 |
| Any, Week 45 | 173 |
| Any, Week 46 | 179 |
| Any, Week 47 | 181 |
| Any, Week 48 | 182 |
| Drowsiness, Week 37 | 0 |
| Drowsiness, Week 38 | 8 |
| Drowsiness, Week 39 | 28 |
| Drowsiness, Week 40 | 46 |
| Drowsiness, Week 41 | 56 |
| Drowsiness, Week 42 | 65 |
| Drowsiness, Week 43 | 66 |
| Drowsiness, Week 44 | 67 |
| Drowsiness, Week 45 | 69 |
| Drowsiness, Week 46 | 71 |
| Drowsiness, Week 47 | 72 |
| Drowsiness, Week 48 | 72 |
| Fatigue, Week 37 | 0 |
| Fatigue, Week 38 | 20 |
| Fatigue, Week 39 | 60 |
| Fatigue, Week 40 | 95 |
| Fatigue, Week 41 | 115 |
| Fatigue, Week 42 | 128 |
| Fatigue, Week 43 | 131 |
| Fatigue, Week 44 | 137 |
| Fatigue, Week 45 | 146 |
| Fatigue, Week 46 | 152 |
| Fatigue, Week 47 | 153 |
| Fatigue, Week 48 | 154 |
| Irritability, Week 37 | 0 |
| Irritability, Week 38 | 3 |
| Irritability, Week 39 | 5 |
| Irritability, Week 40 | 11 |
| Irritability, Week 41 | 12 |
| Irritability, Week 42 | 13 |
| Irritability, Week 43 | 14 |
| Irritability, Week 44 | 15 |
| Irritability, Week 45 | 16 |
| Irritability, Week 46 | 16 |
| Irritability, Week 47 | 16 |
| Irritability, Week 48 | 16 |
| Malaise, Week 37 | 0 |
| Malaise, Week 38 | 0 |
| Malaise, Week 39 | 0 |
| Malaise, Week 40 | 0 |
| Malaise, Week 41 | 0 |
| Malaise, Week 42 | 0 |
| Malaise, Week 43 | 0 |
| Malaise, Week 44 | 0 |
| Malaise, Week 45 | 0 |
| Malaise, Week 46 | 0 |
| Malaise, Week 47 | 0 |
| Malaise, Week 48 | 0 |
Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| Any, Week 37 | 0 |
| Any, Week 38 | 30 |
| Any, Week 39 | 100 |
| Any, Week 40 | 95 |
| Any, Week 41 | 64 |
| Any, Week 42 | 58 |
| Any, Week 43 | 22 |
| Any, Week 44 | 13 |
| Any, Week 45 | 19 |
| Any, Week 46 | 5 |
| Any, Week 47 | 2 |
| Any, Week 48 | 0 |
| Conjunctivitis, Week 37 | 0 |
| Conjunctivitis, Week 38 | 3 |
| Conjunctivitis, Week 39 | 7 |
| Conjunctivitis, Week 40 | 2 |
| Conjunctivitis, Week 41 | 3 |
| Conjunctivitis, Week 42 | 1 |
| Conjunctivitis, Week 43 | 1 |
| Conjunctivitis, Week 44 | 3 |
| Conjunctivitis, Week 45 | 1 |
| Conjunctivitis, Week 46 | 0 |
| Conjunctivitis, Week 47 | 0 |
| Conjunctivitis, Week 48 | 0 |
| Coryza, Week 37 | 0 |
| Coryza, Week 38 | 3 |
| Coryza, Week 39 | 19 |
| Coryza, Week 40 | 26 |
| Coryza, Week 41 | 11 |
| Coryza, Week 42 | 20 |
| Coryza, Week 43 | 4 |
| Coryza, Week 44 | 3 |
| Coryza, Week 45 | 7 |
| Coryza, Week 46 | 2 |
| Coryza, Week 47 | 0 |
| Coryza, Week 48 | 0 |
| Cough, Week 37 | 0 |
| Cough, Week 38 | 9 |
| Cough, Week 39 | 29 |
| Cough, Week 40 | 33 |
| Cough, Week 41 | 22 |
| Cough, Week 42 | 25 |
| Cough, Week 43 | 4 |
| Cough, Week 44 | 5 |
| Cough, Week 45 | 6 |
| Cough, Week 46 | 3 |
| Cough, Week 47 | 0 |
| Cough, Week 48 | 0 |
| Epistaxis, Week 37 | 0 |
| Epistaxis, Week 38 | 0 |
| Epistaxis, Week 39 | 1 |
| Epistaxis, Week 40 | 2 |
| Epistaxis, Week 41 | 3 |
| Epistaxis, Week 42 | 1 |
| Epistaxis, Week 43 | 0 |
| Epistaxis, Week 44 | 0 |
| Epistaxis, Week 45 | 2 |
| Epistaxis, Week 46 | 0 |
| Epistaxis, Week 47 | 0 |
| Epistaxis, Week 48 | 0 |
| Hoarseness, Week 37 | 0 |
| Hoarseness, Week 38 | 6 |
| Hoarseness, Week 39 | 15 |
| Hoarseness, Week 40 | 16 |
| Hoarseness, Week 41 | 14 |
| Hoarseness, Week 42 | 8 |
| Hoarseness, Week 43 | 2 |
| Hoarseness, Week 44 | 2 |
| Hoarseness, Week 45 | 3 |
| Hoarseness, Week 46 | 3 |
| Hoarseness, Week 47 | 0 |
| Hoarseness, Week 48 | 0 |
| Nasal congestion, Week 37 | 0 |
| Nasal congestion, Week 38 | 21 |
| Nasal congestion, Week 39 | 69 |
| Nasal congestion, Week 40 | 54 |
| Nasal congestion, Week 41 | 45 |
| Nasal congestion, Week 42 | 33 |
| Nasal congestion, Week 43 | 18 |
| Nasal congestion, Week 44 | 7 |
| Nasal congestion, Week 45 | 15 |
| Nasal congestion, Week 46 | 4 |
| Nasal congestion, Week 47 | 1 |
| Nasal congestion, Week 48 | 0 |
| Oropharyngeal pain, Week 37 | 0 |
| Oropharyngeal pain, Week 38 | 9 |
| Oropharyngeal pain, Week 39 | 32 |
| Oropharyngeal pain, Week 40 | 38 |
| Oropharyngeal pain, Week 41 | 21 |
| Oropharyngeal pain, Week 42 | 25 |
| Oropharyngeal pain, Week 43 | 9 |
| Oropharyngeal pain, Week 44 | 5 |
| Oropharyngeal pain, Week 45 | 7 |
| Oropharyngeal pain, Week 46 | 2 |
| Oropharyngeal pain, Week 47 | 2 |
| Oropharyngeal pain, Week 48 | 0 |
| Rhinorrhoea, Week 37 | 0 |
| Rhinorrhoea, Week 38 | 17 |
| Rhinorrhoea, Week 39 | 58 |
| Rhinorrhoea, Week 40 | 53 |
| Rhinorrhoea, Week 41 | 44 |
| Rhinorrhoea, Week 42 | 27 |
| Rhinorrhoea, Week 43 | 17 |
| Rhinorrhoea, Week 44 | 5 |
| Rhinorrhoea, Week 45 | 14 |
| Rhinorrhoea, Week 46 | 4 |
| Rhinorrhoea, Week 47 | 1 |
| Rhinorrhoea, Week 48 | 0 |
| Wheezing, Week 37 | 0 |
| Wheezing, Week 38 | 2 |
| Wheezing, Week 39 | 9 |
| Wheezing, Week 40 | 11 |
| Wheezing, Week 41 | 7 |
| Wheezing, Week 42 | 12 |
| Wheezing, Week 43 | 2 |
| Wheezing, Week 44 | 5 |
| Wheezing, Week 45 | 3 |
| Wheezing, Week 46 | 2 |
| Wheezing, Week 47 | 0 |
| Wheezing, Week 48 | 0 |
Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| Any, Week 37 | 0 |
| Any, Week 38 | 30 |
| Any, Week 39 | 130 |
| Any, Week 40 | 225 |
| Any, Week 41 | 289 |
| Any, Week 42 | 347 |
| Any, Week 43 | 369 |
| Any, Week 44 | 382 |
| Any, Week 45 | 401 |
| Any, Week 46 | 406 |
| Any, Week 47 | 408 |
| Any, Week 48 | 408 |
| Conjunctivitis, Week 37 | 0 |
| Conjunctivitis, Week 38 | 3 |
| Conjunctivitis, Week 39 | 10 |
| Conjunctivitis, Week 40 | 12 |
| Conjunctivitis, Week 41 | 15 |
| Conjunctivitis, Week 42 | 16 |
| Conjunctivitis, Week 43 | 17 |
| Conjunctivitis, Week 44 | 20 |
| Conjunctivitis, Week 45 | 21 |
| Conjunctivitis, Week 46 | 21 |
| Conjunctivitis, Week 47 | 21 |
| Conjunctivitis, Week 48 | 21 |
| Coryza, Week 37 | 0 |
| Coryza, Week 38 | 3 |
| Coryza, Week 39 | 22 |
| Coryza, Week 40 | 48 |
| Coryza, Week 41 | 59 |
| Coryza, Week 42 | 79 |
| Coryza, Week 43 | 83 |
| Coryza, Week 44 | 86 |
| Coryza, Week 45 | 93 |
| Coryza, Week 46 | 95 |
| Coryza, Week 47 | 95 |
| Coryza, Week 48 | 95 |
| Cough, Week 37 | 0 |
| Cough, Week 38 | 9 |
| Cough, Week 39 | 38 |
| Cough, Week 40 | 71 |
| Cough, Week 41 | 93 |
| Cough, Week 42 | 118 |
| Cough, Week 43 | 122 |
| Cough, Week 44 | 127 |
| Cough, Week 45 | 133 |
| Cough, Week 46 | 136 |
| Cough, Week 47 | 136 |
| Cough, Week 48 | 136 |
| Epistaxis, Week 37 | 0 |
| Epistaxis, Week 38 | 0 |
| Epistaxis, Week 39 | 1 |
| Epistaxis, Week 40 | 3 |
| Epistaxis, Week 41 | 6 |
| Epistaxis, Week 42 | 7 |
| Epistaxis, Week 43 | 7 |
| Epistaxis, Week 44 | 7 |
| Epistaxis, Week 45 | 9 |
| Epistaxis, Week 46 | 9 |
| Epistaxis, Week 47 | 9 |
| Epistaxis, Week 48 | 9 |
| Hoarseness, Week 37 | 0 |
| Hoarseness, Week 38 | 6 |
| Hoarseness, Week 39 | 21 |
| Hoarseness, Week 40 | 37 |
| Hoarseness, Week 41 | 51 |
| Hoarseness, Week 42 | 59 |
| Hoarseness, Week 43 | 61 |
| Hoarseness, Week 44 | 63 |
| Hoarseness, Week 45 | 66 |
| Hoarseness, Week 46 | 69 |
| Hoarseness, Week 47 | 69 |
| Hoarseness, Week 48 | 69 |
| Nasal congestion, Week 37 | 0 |
| Nasal congestion, Week 38 | 21 |
| Nasal congestion, Week 39 | 90 |
| Nasal congestion, Week 40 | 144 |
| Nasal congestion, Week 41 | 189 |
| Nasal congestion, Week 42 | 222 |
| Nasal congestion, Week 43 | 240 |
| Nasal congestion, Week 44 | 247 |
| Nasal congestion, Week 45 | 262 |
| Nasal congestion, Week 46 | 266 |
| Nasal congestion, Week 47 | 267 |
| Nasal congestion, Week 48 | 267 |
| Oropharyngeal pain, Week 37 | 0 |
| Oropharyngeal pain, Week 38 | 9 |
| Oropharyngeal pain, Week 39 | 41 |
| Oropharyngeal pain, Week 40 | 79 |
| Oropharyngeal pain, Week 41 | 100 |
| Oropharyngeal pain, Week 42 | 125 |
| Oropharyngeal pain, Week 43 | 134 |
| Oropharyngeal pain, Week 44 | 139 |
| Oropharyngeal pain, Week 45 | 146 |
| Oropharyngeal pain, Week 46 | 148 |
| Oropharyngeal pain, Week 47 | 150 |
| Oropharyngeal pain, Week 48 | 150 |
| Rhinorrhoea, Week 37 | 0 |
| Rhinorrhoea, Week 38 | 17 |
| Rhinorrhoea, Week 39 | 75 |
| Rhinorrhoea, Week 40 | 128 |
| Rhinorrhoea, Week 41 | 172 |
| Rhinorrhoea, Week 42 | 199 |
| Rhinorrhoea, Week 43 | 216 |
| Rhinorrhoea, Week 44 | 221 |
| Rhinorrhoea, Week 45 | 235 |
| Rhinorrhoea, Week 46 | 239 |
| Rhinorrhoea, Week 47 | 240 |
| Rhinorrhoea, Week 48 | 240 |
| Wheezing, Week 37 | 0 |
| Wheezing, Week 38 | 2 |
| Wheezing, Week 39 | 11 |
| Wheezing, Week 40 | 22 |
| Wheezing, Week 41 | 29 |
| Wheezing, Week 42 | 41 |
| Wheezing, Week 43 | 43 |
| Wheezing, Week 44 | 48 |
| Wheezing, Week 45 | 51 |
| Wheezing, Week 46 | 53 |
| Wheezing, Week 47 | 53 |
| Wheezing, Week 48 | 53 |
Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| Any, Week 37 | 0 |
| Any, Week 38 | 15 |
| Any, Week 39 | 29 |
| Any, Week 40 | 29 |
| Any, Week 41 | 21 |
| Any, Week 42 | 18 |
| Any, Week 43 | 6 |
| Any, Week 44 | 4 |
| Any, Week 45 | 5 |
| Any, Week 46 | 3 |
| Any, Week 47 | 0 |
| Any, Week 48 | 1 |
| Decreased appetite, Week 37 | 0 |
| Decreased appetite, Week 38 | 7 |
| Decreased appetite, Week 39 | 11 |
| Decreased appetite, Week 40 | 11 |
| Decreased appetite, Week 41 | 7 |
| Decreased appetite, Week 42 | 6 |
| Decreased appetite, Week 43 | 2 |
| Decreased appetite, Week 44 | 1 |
| Decreased appetite, Week 45 | 2 |
| Decreased appetite, Week 46 | 2 |
| Decreased appetite, Week 47 | 0 |
| Decreased appetite, Week 48 | 0 |
| Diarrhoea, Week 37 | 0 |
| Diarrhoea, Week 38 | 5 |
| Diarrhoea, Week 39 | 10 |
| Diarrhoea, Week 40 | 12 |
| Diarrhoea, Week 41 | 8 |
| Diarrhoea, Week 42 | 5 |
| Diarrhoea, Week 43 | 3 |
| Diarrhoea, Week 44 | 3 |
| Diarrhoea, Week 45 | 2 |
| Diarrhoea, Week 46 | 0 |
| Diarrhoea, Week 47 | 0 |
| Diarrhoea, Week 48 | 0 |
| Nausea, Week 37 | 0 |
| Nausea, Week 38 | 11 |
| Nausea, Week 39 | 17 |
| Nausea, Week 40 | 14 |
| Nausea, Week 41 | 8 |
| Nausea, Week 42 | 9 |
| Nausea, Week 43 | 2 |
| Nausea, Week 44 | 0 |
| Nausea, Week 45 | 4 |
| Nausea, Week 46 | 1 |
| Nausea, Week 47 | 0 |
| Nausea, Week 48 | 1 |
| Vomiting, Week 37 | 0 |
| Vomiting, Week 38 | 2 |
| Vomiting, Week 39 | 2 |
| Vomiting, Week 40 | 6 |
| Vomiting, Week 41 | 1 |
| Vomiting, Week 42 | 3 |
| Vomiting, Week 43 | 0 |
| Vomiting, Week 44 | 0 |
| Vomiting, Week 45 | 2 |
| Vomiting, Week 46 | 0 |
| Vomiting, Week 47 | 0 |
| Vomiting, Week 48 | 0 |
Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| Any, Week 37 | 0 |
| Any, Week 38 | 15 |
| Any, Week 39 | 44 |
| Any, Week 40 | 73 |
| Any, Week 41 | 94 |
| Any, Week 42 | 112 |
| Any, Week 43 | 118 |
| Any, Week 44 | 122 |
| Any, Week 45 | 127 |
| Any, Week 46 | 130 |
| Any, Week 47 | 130 |
| Any, Week 48 | 131 |
| Decreased appetite, Week 37 | 0 |
| Decreased appetite, Week 38 | 7 |
| Decreased appetite, Week 39 | 18 |
| Decreased appetite, Week 40 | 29 |
| Decreased appetite, Week 41 | 36 |
| Decreased appetite, Week 42 | 42 |
| Decreased appetite, Week 43 | 44 |
| Decreased appetite, Week 44 | 45 |
| Decreased appetite, Week 45 | 47 |
| Decreased appetite, Week 46 | 49 |
| Decreased appetite, Week 47 | 49 |
| Decreased appetite, Week 48 | 49 |
| Diarrhoea, Week 37 | 0 |
| Diarrhoea, Week 38 | 5 |
| Diarrhoea, Week 39 | 15 |
| Diarrhoea, Week 40 | 27 |
| Diarrhoea, Week 41 | 35 |
| Diarrhoea, Week 42 | 40 |
| Diarrhoea, Week 43 | 43 |
| Diarrhoea, Week 44 | 46 |
| Diarrhoea, Week 45 | 48 |
| Diarrhoea, Week 46 | 48 |
| Diarrhoea, Week 47 | 48 |
| Diarrhoea, Week 48 | 48 |
| Nausea, Week 37 | 0 |
| Nausea, Week 38 | 11 |
| Nausea, Week 39 | 28 |
| Nausea, Week 40 | 42 |
| Nausea, Week 41 | 50 |
| Nausea, Week 42 | 59 |
| Nausea, Week 43 | 61 |
| Nausea, Week 44 | 61 |
| Nausea, Week 45 | 65 |
| Nausea, Week 46 | 66 |
| Nausea, Week 47 | 66 |
| Nausea, Week 48 | 67 |
| Vomiting, Week 37 | 0 |
| Vomiting, Week 38 | 2 |
| Vomiting, Week 39 | 4 |
| Vomiting, Week 40 | 10 |
| Vomiting, Week 41 | 11 |
| Vomiting, Week 42 | 14 |
| Vomiting, Week 43 | 14 |
| Vomiting, Week 44 | 14 |
| Vomiting, Week 45 | 16 |
| Vomiting, Week 46 | 16 |
| Vomiting, Week 47 | 16 |
| Vomiting, Week 48 | 16 |
Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| Any, Week 37 | 0 |
| Any, Week 38 | 0 |
| Any, Week 39 | 0 |
| Any, Week 40 | 3 |
| Any, Week 41 | 0 |
| Any, Week 42 | 2 |
| Any, Week 43 | 0 |
| Any, Week 44 | 1 |
| Any, Week 45 | 1 |
| Any, Week 46 | 0 |
| Any, Week 47 | 0 |
| Any, Week 48 | 0 |
| Anaphylactic reactions, Week 37 | 0 |
| Anaphylactic reactions, Week 38 | 0 |
| Anaphylactic reactions, Week 39 | 0 |
| Anaphylactic reactions, Week 40 | 0 |
| Anaphylactic reactions, Week 41 | 0 |
| Anaphylactic reactions, Week 42 | 0 |
| Anaphylactic reactions, Week 43 | 0 |
| Anaphylactic reactions, Week 44 | 0 |
| Anaphylactic reactions, Week 45 | 0 |
| Anaphylactic reactions, Week 46 | 0 |
| Anaphylactic reactions, Week 47 | 0 |
| Anaphylactic reactions, Week 48 | 0 |
| Facial oedema, Week 37 | 0 |
| Facial oedema, Week 38 | 0 |
| Facial oedema, Week 39 | 0 |
| Facial oedema, Week 40 | 1 |
| Facial oedema, Week 41 | 0 |
| Facial oedema, Week 42 | 0 |
| Facial oedema, Week 43 | 0 |
| Facial oedema, Week 44 | 0 |
| Facial oedema, Week 45 | 0 |
| Facial oedema, Week 46 | 0 |
| Facial oedema, Week 47 | 0 |
| Facial oedema, Week 48 | 0 |
| Hypersensitivity reactions, Week 37 | 0 |
| Hypersensitivity reactions, Week 38 | 0 |
| Hypersensitivity reactions, Week 39 | 0 |
| Hypersensitivity reactions, Week 40 | 2 |
| Hypersensitivity reactions, Week 41 | 0 |
| Hypersensitivity reactions, Week 42 | 2 |
| Hypersensitivity reactions, Week 43 | 0 |
| Hypersensitivity reactions, Week 44 | 1 |
| Hypersensitivity reactions, Week 45 | 1 |
| Hypersensitivity reactions, Week 46 | 0 |
| Hypersensitivity reactions, Week 47 | 0 |
| Hypersensitivity reactions, Week 48 | 0 |
Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| Any, Week 37 | 0 |
| Any, Week 38 | 0 |
| Any, Week 39 | 0 |
| Any, Week 40 | 3 |
| Any, Week 41 | 3 |
| Any, Week 42 | 5 |
| Any, Week 43 | 5 |
| Any, Week 44 | 6 |
| Any, Week 45 | 7 |
| Any, Week 46 | 7 |
| Any, Week 47 | 7 |
| Any, Week 48 | 7 |
| Anaphylactic reactions, Week 37 | 0 |
| Anaphylactic reactions, Week 38 | 0 |
| Anaphylactic reactions, Week 39 | 0 |
| Anaphylactic reactions, Week 40 | 0 |
| Anaphylactic reactions, Week 41 | 0 |
| Anaphylactic reactions, Week 42 | 0 |
| Anaphylactic reactions, Week 43 | 0 |
| Anaphylactic reactions, Week 44 | 0 |
| Anaphylactic reactions, Week 45 | 0 |
| Anaphylactic reactions, Week 46 | 0 |
| Anaphylactic reactions, Week 47 | 0 |
| Anaphylactic reactions, Week 48 | 0 |
| Facial oedema, Week 37 | 0 |
| Facial oedema, Week 38 | 0 |
| Facial oedema, Week 39 | 0 |
| Facial oedema, Week 40 | 1 |
| Facial oedema, Week 41 | 1 |
| Facial oedema, Week 42 | 1 |
| Facial oedema, Week 43 | 1 |
| Facial oedema, Week 44 | 1 |
| Facial oedema, Week 45 | 1 |
| Facial oedema, Week 46 | 1 |
| Facial oedema, Week 47 | 1 |
| Facial oedema, Week 48 | 1 |
| Hypersensitivity reactions, Week 37 | 0 |
| Hypersensitivity reactions, Week 38 | 0 |
| Hypersensitivity reactions, Week 39 | 0 |
| Hypersensitivity reactions, Week 40 | 2 |
| Hypersensitivity reactions, Week 41 | 2 |
| Hypersensitivity reactions, Week 42 | 4 |
| Hypersensitivity reactions, Week 43 | 4 |
| Hypersensitivity reactions, Week 44 | 5 |
| Hypersensitivity reactions, Week 45 | 6 |
| Hypersensitivity reactions, Week 46 | 6 |
| Hypersensitivity reactions, Week 47 | 6 |
| Hypersensitivity reactions, Week 48 | 6 |
Rash AEs include any rash AEs, generalised rash and rash. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| Any, Week 37 | 0 |
| Any, Week 38 | 1 |
| Any, Week 39 | 0 |
| Any, Week 40 | 5 |
| Any, Week 41 | 1 |
| Any, Week 42 | 3 |
| Any, Week 43 | 3 |
| Any, Week 44 | 1 |
| Any, Week 45 | 1 |
| Any, Week 46 | 2 |
| Any, Week 47 | 0 |
| Any, Week 48 | 0 |
| Generalised rash, Week 37 | 0 |
| Generalised rash, Week 38 | 0 |
| Generalised rash, Week 39 | 0 |
| Generalised rash, Week 40 | 1 |
| Generalised rash, Week 41 | 0 |
| Generalised rash, Week 42 | 0 |
| Generalised rash, Week 43 | 0 |
| Generalised rash, Week 44 | 0 |
| Generalised rash, Week 45 | 0 |
| Generalised rash, Week 46 | 0 |
| Generalised rash, Week 47 | 0 |
| Generalised rash, Week 48 | 0 |
| Rash, Week 37 | 0 |
| Rash, Week 38 | 1 |
| Rash, Week 39 | 0 |
| Rash, Week 40 | 4 |
| Rash, Week 41 | 1 |
| Rash, Week 42 | 3 |
| Rash, Week 43 | 3 |
| Rash, Week 44 | 1 |
| Rash, Week 45 | 1 |
| Rash, Week 46 | 2 |
| Rash, Week 47 | 0 |
| Rash, Week 48 | 0 |
Rash AEs include any rash AEs, generalised rash and rash. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| Any, Week 37 | 0 |
| Any, Week 38 | 1 |
| Any, Week 39 | 1 |
| Any, Week 40 | 6 |
| Any, Week 41 | 7 |
| Any, Week 42 | 10 |
| Any, Week 43 | 13 |
| Any, Week 44 | 14 |
| Any, Week 45 | 15 |
| Any, Week 46 | 17 |
| Any, Week 47 | 17 |
| Any, Week 48 | 17 |
| Generalised rash, Week 37 | 0 |
| Generalised rash, Week 38 | 0 |
| Generalised rash, Week 39 | 0 |
| Generalised rash, Week 40 | 1 |
| Generalised rash, Week 41 | 1 |
| Generalised rash, Week 42 | 1 |
| Generalised rash, Week 43 | 1 |
| Generalised rash, Week 44 | 1 |
| Generalised rash, Week 45 | 1 |
| Generalised rash, Week 46 | 1 |
| Generalised rash, Week 47 | 1 |
| Generalised rash, Week 48 | 1 |
| Rash, Week 37 | 0 |
| Rash, Week 38 | 1 |
| Rash, Week 39 | 1 |
| Rash, Week 40 | 5 |
| Rash, Week 41 | 6 |
| Rash, Week 42 | 9 |
| Rash, Week 43 | 12 |
| Rash, Week 44 | 13 |
| Rash, Week 45 | 14 |
| Rash, Week 46 | 16 |
| Rash, Week 47 | 16 |
| Rash, Week 48 | 16 |
Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| Any, Week 37 | 0 |
| Any, Week 38 | 27 |
| Any, Week 39 | 60 |
| Any, Week 40 | 64 |
| Any, Week 41 | 32 |
| Any, Week 42 | 33 |
| Any, Week 43 | 7 |
| Any, Week 44 | 9 |
| Any, Week 45 | 13 |
| Any, Week 46 | 7 |
| Any, Week 47 | 2 |
| Any, Week 48 | 1 |
| Arthropathy, Week 37 | 0 |
| Arthropathy, Week 38 | 8 |
| Arthropathy, Week 39 | 17 |
| Arthropathy, Week 40 | 24 |
| Arthropathy, Week 41 | 9 |
| Arthropathy, Week 42 | 11 |
| Arthropathy, Week 43 | 2 |
| Arthropathy, Week 44 | 2 |
| Arthropathy, Week 45 | 5 |
| Arthropathy, Week 46 | 1 |
| Arthropathy, Week 47 | 0 |
| Arthropathy, Week 48 | 0 |
| Muscle aches/myalgia, Week 37 | 0 |
| Muscle aches/myalgia, Week 38 | 25 |
| Muscle aches/myalgia, Week 39 | 58 |
| Muscle aches/myalgia, Week 40 | 57 |
| Muscle aches/myalgia, Week 41 | 30 |
| Muscle aches/myalgia, Week 42 | 29 |
| Muscle aches/myalgia, Week 43 | 7 |
| Muscle aches/myalgia, Week 44 | 7 |
| Muscle aches/myalgia, Week 45 | 13 |
| Muscle aches/myalgia, Week 46 | 6 |
| Muscle aches/myalgia, Week 47 | 2 |
| Muscle aches/myalgia, Week 48 | 1 |
Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| Any, Week 37 | 0 |
| Any, Week 38 | 27 |
| Any, Week 39 | 87 |
| Any, Week 40 | 151 |
| Any, Week 41 | 183 |
| Any, Week 42 | 216 |
| Any, Week 43 | 223 |
| Any, Week 44 | 232 |
| Any, Week 45 | 245 |
| Any, Week 46 | 252 |
| Any, Week 47 | 254 |
| Any, Week 48 | 255 |
| Arthropathy, Week 37 | 0 |
| Arthropathy, Week 38 | 8 |
| Arthropathy, Week 39 | 25 |
| Arthropathy, Week 40 | 49 |
| Arthropathy, Week 41 | 58 |
| Arthropathy, Week 42 | 69 |
| Arthropathy, Week 43 | 71 |
| Arthropathy, Week 44 | 73 |
| Arthropathy, Week 45 | 78 |
| Arthropathy, Week 46 | 79 |
| Arthropathy, Week 47 | 79 |
| Arthropathy, Week 48 | 79 |
| Muscle aches/myalgia, Week 37 | 0 |
| Muscle aches/myalgia, Week 38 | 25 |
| Muscle aches/myalgia, Week 39 | 83 |
| Muscle aches/myalgia, Week 40 | 140 |
| Muscle aches/myalgia, Week 41 | 170 |
| Muscle aches/myalgia, Week 42 | 199 |
| Muscle aches/myalgia, Week 43 | 206 |
| Muscle aches/myalgia, Week 44 | 213 |
| Muscle aches/myalgia, Week 45 | 226 |
| Muscle aches/myalgia, Week 46 | 232 |
| Muscle aches/myalgia, Week 47 | 234 |
| Muscle aches/myalgia, Week 48 | 235 |
Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| Any, Week 37 | 0 |
| Any, Week 38 | 19 |
| Any, Week 39 | 48 |
| Any, Week 40 | 42 |
| Any, Week 41 | 25 |
| Any, Week 42 | 15 |
| Any, Week 43 | 10 |
| Any, Week 44 | 5 |
| Any, Week 45 | 10 |
| Any, Week 46 | 3 |
| Any, Week 47 | 0 |
| Any, Week 48 | 1 |
| Bell's palsy, Week 37 | 0 |
| Bell's palsy, Week 38 | 0 |
| Bell's palsy, Week 39 | 0 |
| Bell's palsy, Week 40 | 0 |
| Bell's palsy, Week 41 | 0 |
| Bell's palsy, Week 42 | 0 |
| Bell's palsy, Week 43 | 0 |
| Bell's palsy, Week 44 | 0 |
| Bell's palsy, Week 45 | 0 |
| Bell's palsy, Week 46 | 0 |
| Bell's palsy, Week 47 | 0 |
| Bell's palsy, Week 48 | 0 |
| Guillain-Barre Syndrome, Week 37 | 0 |
| Guillain-Barre Syndrome, Week 38 | 0 |
| Guillain-Barre Syndrome, Week 39 | 0 |
| Guillain-Barre Syndrome, Week 40 | 0 |
| Guillain-Barre Syndrome, Week 41 | 0 |
| Guillain-Barre Syndrome, Week 42 | 0 |
| Guillain-Barre Syndrome, Week 43 | 0 |
| Guillain-Barre Syndrome, Week 44 | 0 |
| Guillain-Barre Syndrome, Week 45 | 0 |
| Guillain-Barre Syndrome, Week 46 | 0 |
| Guillain-Barre Syndrome, Week 47 | 0 |
| Guillain-Barre Syndrome, Week 48 | 0 |
| Headache, Week 37 | 0 |
| Headache, Week 38 | 17 |
| Headache, Week 39 | 48 |
| Headache, Week 40 | 40 |
| Headache, Week 41 | 23 |
| Headache, Week 42 | 13 |
| Headache, Week 43 | 8 |
| Headache, Week 44 | 5 |
| Headache, Week 45 | 9 |
| Headache, Week 46 | 3 |
| Headache, Week 47 | 0 |
| Headache, Week 48 | 1 |
| Peripheral tremor, Week 37 | 0 |
| Peripheral tremor, Week 38 | 3 |
| Peripheral tremor, Week 39 | 5 |
| Peripheral tremor, Week 40 | 1 |
| Peripheral tremor, Week 41 | 7 |
| Peripheral tremor, Week 42 | 3 |
| Peripheral tremor, Week 43 | 2 |
| Peripheral tremor, Week 44 | 0 |
| Peripheral tremor, Week 45 | 1 |
| Peripheral tremor, Week 46 | 0 |
| Peripheral tremor, Week 47 | 0 |
| Peripheral tremor, Week 48 | 0 |
| Seizure/Febrile convulsions, Week 37 | 0 |
| Seizure/Febrile convulsions, Week 38 | 0 |
| Seizure/Febrile convulsions, Week 39 | 0 |
| Seizure/Febrile convulsions, Week 40 | 1 |
| Seizure/Febrile convulsions, Week 41 | 0 |
| Seizure/Febrile convulsions, Week 42 | 0 |
| Seizure/Febrile convulsions, Week 43 | 0 |
| Seizure/Febrile convulsions, Week 44 | 0 |
| Seizure/Febrile convulsions, Week 45 | 0 |
| Seizure/Febrile convulsions, Week 46 | 0 |
| Seizure/Febrile convulsions, Week 47 | 0 |
| Seizure/Febrile convulsions, Week 48 | 0 |
Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| Any, Week 37 | 0 |
| Any, Week 38 | 19 |
| Any, Week 39 | 67 |
| Any, Week 40 | 109 |
| Any, Week 41 | 134 |
| Any, Week 42 | 149 |
| Any, Week 43 | 159 |
| Any, Week 44 | 164 |
| Any, Week 45 | 174 |
| Any, Week 46 | 177 |
| Any, Week 47 | 177 |
| Any, Week 48 | 178 |
| Bell's palsy, Week 37 | 0 |
| Bell's palsy, Week 38 | 0 |
| Bell's palsy, Week 39 | 0 |
| Bell's palsy, Week 40 | 0 |
| Bell's palsy, Week 41 | 0 |
| Bell's palsy, Week 42 | 0 |
| Bell's palsy, Week 43 | 0 |
| Bell's palsy, Week 44 | 0 |
| Bell's palsy, Week 45 | 0 |
| Bell's palsy, Week 46 | 0 |
| Bell's palsy, Week 47 | 0 |
| Bell's palsy, Week 48 | 0 |
| Guillain-Barre Syndrome, Week 37 | 0 |
| Guillain-Barre Syndrome, Week 38 | 0 |
| Guillain-Barre Syndrome, Week 39 | 0 |
| Guillain-Barre Syndrome, Week 40 | 0 |
| Guillain-Barre Syndrome, Week 41 | 0 |
| Guillain-Barre Syndrome, Week 42 | 0 |
| Guillain-Barre Syndrome, Week 43 | 0 |
| Guillain-Barre Syndrome, Week 44 | 0 |
| Guillain-Barre Syndrome, Week 45 | 0 |
| Guillain-Barre Syndrome, Week 46 | 0 |
| Guillain-Barre Syndrome, Week 47 | 0 |
| Guillain-Barre Syndrome, Week 48 | 0 |
| Headache, Week 37 | 0 |
| Headache, Week 38 | 17 |
| Headache, Week 39 | 65 |
| Headache, Week 40 | 105 |
| Headache, Week 41 | 128 |
| Headache, Week 42 | 141 |
| Headache, Week 43 | 149 |
| Headache, Week 44 | 154 |
| Headache, Week 45 | 163 |
| Headache, Week 46 | 166 |
| Headache, Week 47 | 166 |
| Headache, Week 48 | 167 |
| Peripheral tremor, Week 37 | 0 |
| Peripheral tremor, Week 38 | 3 |
| Peripheral tremor, Week 39 | 8 |
| Peripheral tremor, Week 40 | 9 |
| Peripheral tremor, Week 41 | 16 |
| Peripheral tremor, Week 42 | 19 |
| Peripheral tremor, Week 43 | 21 |
| Peripheral tremor, Week 44 | 21 |
| Peripheral tremor, Week 45 | 22 |
| Peripheral tremor, Week 46 | 22 |
| Peripheral tremor, Week 47 | 22 |
| Peripheral tremor, Week 48 | 22 |
| Seizure/Febrile convulsions, Week 37 | 0 |
| Seizure/Febrile convulsions, Week 38 | 0 |
| Seizure/Febrile convulsions, Week 39 | 0 |
| Seizure/Febrile convulsions, Week 40 | 1 |
| Seizure/Febrile convulsions, Week 41 | 1 |
| Seizure/Febrile convulsions, Week 42 | 1 |
| Seizure/Febrile convulsions, Week 43 | 1 |
| Seizure/Febrile convulsions, Week 44 | 1 |
| Seizure/Febrile convulsions, Week 45 | 1 |
| Seizure/Febrile convulsions, Week 46 | 1 |
| Seizure/Febrile convulsions, Week 47 | 1 |
| Seizure/Febrile convulsions, Week 48 | 1 |
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| 6 months - 5 years, Week 37 | 0 |
| 6 months - 5 years, Week 38 | 0 |
| 6 months - 5 years, Week 39 | 0 |
| 6 months - 5 years, Week 40 | 0 |
| 6 months - 5 years, Week 41 | 0 |
| 6 months - 5 years, Week 42 | 0 |
| 6 months - 5 years, Week 43 | 0 |
| 6 months - 5 years, Week 44 | 0 |
| 6 months - 5 years, Week 45 | 0 |
| 6 months - 5 years, Week 46 | 0 |
| 6 months - 5 years, Week 47 | 0 |
| 6 months - 5 years, Week 48 | 0 |
| 6-12 years, Week 37 | 0 |
| 6-12 years, Week 38 | 0 |
| 6-12 years, Week 39 | 0 |
| 6-12 years, Week 40 | 0 |
| 6-12 years, Week 41 | 0 |
| 6-12 years, Week 42 | 0 |
| 6-12 years, Week 43 | 0 |
| 6-12 years, Week 44 | 0 |
| 6-12 years, Week 45 | 0 |
| 6-12 years, Week 46 | 0 |
| 6-12 years, Week 47 | 0 |
| 6-12 years, Week 48 | 0 |
| 13-17 years, Week 37 | 0 |
| 13-17 years, Week 38 | 0 |
| 13-17 years, Week 39 | 0 |
| 13-17 years, Week 40 | 0 |
| 13-17 years, Week 41 | 0 |
| 13-17 years, Week 42 | 1 |
| 13-17 years, Week 43 | 0 |
| 13-17 years, Week 44 | 0 |
| 13-17 years, Week 45 | 0 |
| 13-17 years, Week 46 | 0 |
| 13-17 years, Week 47 | 0 |
| 13-17 years, Week 48 | 0 |
| 18-65 years, Week 37 | 0 |
| 18-65 years, Week 38 | 21 |
| 18-65 years, Week 39 | 45 |
| 18-65 years, Week 40 | 57 |
| 18-65 years, Week 41 | 36 |
| 18-65 years, Week 42 | 38 |
| 18-65 years, Week 43 | 10 |
| 18-65 years, Week 44 | 12 |
| 18-65 years, Week 45 | 12 |
| 18-65 years, Week 46 | 5 |
| 18-65 years, Week 47 | 1 |
| 18-65 years, Week 48 | 1 |
| >65 years, Week 37 | 0 |
| >65 years, Week 38 | 46 |
| >65 years, Week 39 | 124 |
| >65 years, Week 40 | 107 |
| >65 years, Week 41 | 76 |
| >65 years, Week 42 | 46 |
| >65 years, Week 43 | 19 |
| >65 years, Week 44 | 19 |
| >65 years, Week 45 | 16 |
| >65 years, Week 46 | 8 |
| >65 years, Week 47 | 2 |
| >65 years, Week 48 | 1 |
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| 6 months - 5 years, Week 37 | 0 |
| 6 months - 5 years, Week 38 | 0 |
| 6 months - 5 years, Week 39 | 0 |
| 6 months - 5 years, Week 40 | 0 |
| 6 months - 5 years, Week 41 | 0 |
| 6 months - 5 years, Week 42 | 0 |
| 6 months - 5 years, Week 43 | 0 |
| 6 months - 5 years, Week 44 | 0 |
| 6 months - 5 years, Week 45 | 0 |
| 6 months - 5 years, Week 46 | 0 |
| 6 months - 5 years, Week 47 | 0 |
| 6 months - 5 years, Week 48 | 0 |
| 6-12 years, Week 37 | 0 |
| 6-12 years, Week 38 | 0 |
| 6-12 years, Week 39 | 0 |
| 6-12 years, Week 40 | 0 |
| 6-12 years, Week 41 | 0 |
| 6-12 years, Week 42 | 0 |
| 6-12 years, Week 43 | 0 |
| 6-12 years, Week 44 | 0 |
| 6-12 years, Week 45 | 0 |
| 6-12 years, Week 46 | 0 |
| 6-12 years, Week 47 | 0 |
| 6-12 years, Week 48 | 0 |
| 13-17 years, Week 37 | 0 |
| 13-17 years, Week 38 | 0 |
| 13-17 years, Week 39 | 0 |
| 13-17 years, Week 40 | 0 |
| 13-17 years, Week 41 | 0 |
| 13-17 years, Week 42 | 1 |
| 13-17 years, Week 43 | 1 |
| 13-17 years, Week 44 | 1 |
| 13-17 years, Week 45 | 1 |
| 13-17 years, Week 46 | 1 |
| 13-17 years, Week 47 | 1 |
| 13-17 years, Week 48 | 1 |
| 18-65 years, Week 37 | 0 |
| 18-65 years, Week 38 | 21 |
| 18-65 years, Week 39 | 66 |
| 18-65 years, Week 40 | 123 |
| 18-65 years, Week 41 | 159 |
| 18-65 years, Week 42 | 197 |
| 18-65 years, Week 43 | 207 |
| 18-65 years, Week 44 | 219 |
| 18-65 years, Week 45 | 231 |
| 18-65 years, Week 46 | 236 |
| 18-65 years, Week 47 | 237 |
| 18-65 years, Week 48 | 238 |
| >65 years, Week 37 | 0 |
| >65 years, Week 38 | 46 |
| >65 years, Week 39 | 170 |
| >65 years, Week 40 | 277 |
| >65 years, Week 41 | 353 |
| >65 years, Week 42 | 399 |
| >65 years, Week 43 | 418 |
| >65 years, Week 44 | 437 |
| >65 years, Week 45 | 453 |
| >65 years, Week 46 | 461 |
| >65 years, Week 47 | 463 |
| >65 years, Week 48 | 464 |
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR .
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| 6 months - 5 years, Week 37 | 0 |
| 6 months - 5 years, Week 38 | 0 |
| 6 months - 5 years, Week 39 | 0 |
| 6 months - 5 years, Week 40 | 0 |
| 6 months - 5 years, Week 41 | 0 |
| 6 months - 5 years, Week 42 | 0 |
| 6 months - 5 years, Week 43 | 0 |
| 6 months - 5 years, Week 44 | 0 |
| 6 months - 5 years, Week 45 | 0 |
| 6 months - 5 years, Week 46 | 0 |
| 6 months - 5 years, Week 47 | 0 |
| 6 months - 5 years, Week 48 | 0 |
| 6-12 years, Week 37 | 0 |
| 6-12 years, Week 38 | 0 |
| 6-12 years, Week 39 | 0 |
| 6-12 years, Week 40 | 0 |
| 6-12 years, Week 41 | 0 |
| 6-12 years, Week 42 | 0 |
| 6-12 years, Week 43 | 0 |
| 6-12 years, Week 44 | 0 |
| 6-12 years, Week 45 | 0 |
| 6-12 years, Week 46 | 0 |
| 6-12 years, Week 47 | 0 |
| 6-12 years, Week 48 | 0 |
| 13-17 years, Week 37 | 0 |
| 13-17 years, Week 38 | 0 |
| 13-17 years, Week 39 | 0 |
| 13-17 years, Week 40 | 0 |
| 13-17 years, Week 41 | 0 |
| 13-17 years, Week 42 | 0 |
| 13-17 years, Week 43 | 0 |
| 13-17 years, Week 44 | 0 |
| 13-17 years, Week 45 | 0 |
| 13-17 years, Week 46 | 0 |
| 13-17 years, Week 47 | 0 |
| 13-17 years, Week 48 | 0 |
| 18-65 years, Week 37 | 0 |
| 18-65 years, Week 38 | 1 |
| 18-65 years, Week 39 | 6 |
| 18-65 years, Week 40 | 3 |
| 18-65 years, Week 41 | 4 |
| 18-65 years, Week 42 | 5 |
| 18-65 years, Week 43 | 1 |
| 18-65 years, Week 44 | 1 |
| 18-65 years, Week 45 | 1 |
| 18-65 years, Week 46 | 1 |
| 18-65 years, Week 47 | 0 |
| 18-65 years, Week 48 | 0 |
| >65 years, Week 37 | 0 |
| >65 years, Week 38 | 3 |
| >65 years, Week 39 | 9 |
| >65 years, Week40 | 5 |
| >65 years, Week 41 | 6 |
| >65 years, Week 42 | 4 |
| >65 years, Week 43 | 2 |
| >65 years, Week 44 | 1 |
| >65 years, Week 45 | 2 |
| >65 years, Week 46 | 3 |
| >65 years, Week 47 | 0 |
| >65 years, Week 48 | 0 |
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who receive d the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR .
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| 6 months - 5 years, Week 37 | 0 |
| 6 months - 5 years, Week 38 | 0 |
| 6 months - 5 years, Week 39 | 0 |
| 6 months - 5 years, Week 40 | 0 |
| 6 months - 5 years, Week 41 | 0 |
| 6 months - 5 years, Week 42 | 0 |
| 6 months - 5 years, Week 43 | 0 |
| 6 months - 5 years, Week 44 | 0 |
| 6 months - 5 years, Week 45 | 0 |
| 6 months - 5 years, Week 46 | 0 |
| 6 months - 5 years, Week 47 | 0 |
| 6 months - 5 years, Week 48 | 0 |
| 6-12 years, Week 37 | 0 |
| 6-12 years, Week 38 | 0 |
| 6-12 years, Week 39 | 0 |
| 6-12 years, Week 40 | 0 |
| 6-12 years, Week 41 | 0 |
| 6-12 years, Week 42 | 0 |
| 6-12 years, Week 43 | 0 |
| 6-12 years, Week 44 | 0 |
| 6-12 years, Week 45 | 0 |
| 6-12 years, Week 46 | 0 |
| 6-12 years, Week 47 | 0 |
| 6-12 years, Week 48 | 0 |
| 13-17 years, Week 37 | 0 |
| 13-17 years, Week 38 | 0 |
| 13-17 years, Week 39 | 0 |
| 13-17 years, Week 40 | 0 |
| 13-17 years, Week 41 | 0 |
| 13-17 years, Week 42 | 0 |
| 13-17 years, Week 43 | 0 |
| 13-17 years, Week 44 | 0 |
| 13-17 years, Week 45 | 0 |
| 13-17 years, Week 46 | 0 |
| 13-17 years, Week 47 | 0 |
| 13-17 years, Week 48 | 0 |
| 18-65 years, Week 37 | 0 |
| 18-65 years, Week 38 | 1 |
| 18-65 years, Week 39 | 7 |
| 18-65 years, Week 40 | 10 |
| 18-65 years, Week 41 | 14 |
| 18-65 years, Week 42 | 19 |
| 18-65 years, Week 43 | 20 |
| 18-65 years, Week 44 | 21 |
| 18-65 years, Week 45 | 22 |
| 18-65 years, Week 46 | 23 |
| 18-65 years, Week 47 | 23 |
| 18-65 years, Week 48 | 23 |
| >65 years, Week 37 | 0 |
| >65 years, Week 38 | 3 |
| >65 years, Week 39 | 12 |
| >65 years, Week 40 | 17 |
| >65 years, Week 41 | 23 |
| >65 years, Week 42 | 27 |
| >65 years, Week 43 | 29 |
| >65 years, Week 44 | 30 |
| >65 years, Week 45 | 32 |
| >65 years, Week 46 | 35 |
| >65 years, Week 47 | 35 |
| >65 years, Week 48 | 35 |
Local symptoms included local erythema. The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| 6 months - 5 years: Week 37 | 0 |
| 6 months - 5 years: Week 38 | 0 |
| 6 months - 5 years: Week 39 | 0 |
| 6 months - 5 years: Week 40 | 0 |
| 6 months - 5 years: Week 41 | 0 |
| 6 months - 5 years: Week 42 | 0 |
| 6 months - 5 years: Week 43 | 0 |
| 6 months - 5 years: Week 44 | 0 |
| 6 months - 5 years: Week 45 | 0 |
| 6 months - 5 years: Week 46 | 0 |
| 6 months - 5 years: Week 47 | 0 |
| 6 months - 5 years: Week 48 | 0 |
| 6-12 years: Week 37 | 0 |
| 6-12 years: Week 38 | 0 |
| 6-12 years: Week 39 | 0 |
| 6-12 years: Week 40 | 0 |
| 6-12 years: Week 41 | 0 |
| 6-12 years: Week 42 | 0 |
| 6-12 years: Week 43 | 0 |
| 6-12 years: Week 44 | 0 |
| 6-12 years: Week 45 | 0 |
| 6-12 years: Week 46 | 0 |
| 6-12 years: Week 47 | 0 |
| 6-12 years: Week 48 | 0 |
| 13-17 years: Week 37 | 0 |
| 13-17 years: Week 38 | 0 |
| 13-17 years: Week 39 | 0 |
| 13-17 years: Week 40 | 0 |
| 13-17 years: Week 41 | 0 |
| 13-17 years: Week 42 | 0 |
| 13-17 years: Week 43 | 0 |
| 13-17 years: Week 44 | 0 |
| 13-17 years: Week 45 | 0 |
| 13-17 years: Week 46 | 0 |
| 13-17 years: Week 47 | 0 |
| 13-17 years: Week 48 | 0 |
| 18-65 years: Week 37 | 0 |
| 18-65 years: Week 38 | 9 |
| 18-65 years: Week 39 | 8 |
| 18-65 years: Week 40 | 10 |
| 18-65 years: Week 41 | 12 |
| 18-65 years: Week 42 | 9 |
| 18-65 years: Week 43 | 1 |
| 18-65 years: Week 44 | 4 |
| 18-65 years: Week 45 | 3 |
| 18-65 years: Week 46 | 3 |
| 18-65 years: Week 47 | 0 |
| 18-65 years: Week 48 | 0 |
| >65 years: Week 37 | 0 |
| >65 years: Week 38 | 7 |
| >65 years: Week 39 | 12 |
| >65 years: Week 40 | 14 |
| >65 years: Week 41 | 16 |
| >65 years: Week 42 | 6 |
| >65 years: Week 43 | 5 |
| >65 years: Week 44 | 3 |
| >65 years: Week 45 | 5 |
| >65 years: Week 46 | 0 |
| >65 years: Week 47 | 0 |
| >65 years: Week 48 | 0 |
Local symptoms included local erythema. The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR .
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| 6 months - 5 years: Week 37 | 0 |
| 6 months - 5 years: Week 38 | 0 |
| 6 months - 5 years: Week 39 | 0 |
| 6 months - 5 years: Week 40 | 0 |
| 6 months - 5 years: Week 41 | 0 |
| 6 months - 5 years: Week 42 | 0 |
| 6 months - 5 years: Week 43 | 0 |
| 6 months - 5 years: Week 44 | 0 |
| 6 months - 5 years: Week 45 | 0 |
| 6 months - 5 years: Week 46 | 0 |
| 6 months - 5 years: Week 47 | 0 |
| 6 months - 5 years: Week 48 | 0 |
| 6-12 years: Week 37 | 0 |
| 6-12 years: Week 38 | 0 |
| 6-12 years: Week 39 | 0 |
| 6-12 years: Week 40 | 0 |
| 6-12 years: Week 41 | 0 |
| 6-12 years: Week 42 | 0 |
| 6-12 years: Week 43 | 0 |
| 6-12 years: Week 44 | 0 |
| 6-12 years: Week 45 | 0 |
| 6-12 years: Week 46 | 0 |
| 6-12 years: Week 47 | 0 |
| 6-12 years: Week 48 | 0 |
| 13-17 years: Week 37 | 0 |
| 13-17 years: Week 38 | 0 |
| 13-17 years: Week 39 | 0 |
| 13-17 years: Week 40 | 0 |
| 13-17 years: Week 41 | 0 |
| 13-17 years: Week 42 | 0 |
| 13-17 years: Week 43 | 0 |
| 13-17 years: Week 44 | 0 |
| 13-17 years: Week 45 | 0 |
| 13-17 years: Week 46 | 0 |
| 13-17 years: Week 47 | 0 |
| 13-17 years: Week 48 | 0 |
| 18-65 years: Week 37 | 0 |
| 18-65 years: Week 38 | 9 |
| 18-65 years: Week 39 | 17 |
| 18-65 years: Week 40 | 27 |
| 18-65 years: Week 41 | 39 |
| 18-65 years: Week 42 | 48 |
| 18-65 years: Week 43 | 49 |
| 18-65 years: Week 44 | 53 |
| 18-65 years: Week 45 | 56 |
| 18-65 years: Week 46 | 59 |
| 18-65 years: Week 47 | 59 |
| 18-65 years: Week 48 | 59 |
| >65 years: Week 37 | 0 |
| >65 years: Week 38 | 7 |
| >65 years: Week 39 | 19 |
| >65 years: Week 40 | 33 |
| >65 years: Week 41 | 49 |
| >65 years: Week 42 | 55 |
| >65 years: Week 43 | 60 |
| >65 years: Week 44 | 63 |
| >65 years: Week 45 | 68 |
| >65 years: Week 46 | 68 |
| >65 years: Week 47 | 68 |
| >65 years: Week 48 | 68 |
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR .
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| 6 months - 5 years: Week 37 | 0 |
| 6 months - 5 years: Week 38 | 0 |
| 6 months - 5 years: Week 39 | 0 |
| 6 months - 5 years: Week 40 | 0 |
| 6 months - 5 years: Week 41 | 0 |
| 6 months - 5 years: Week 42 | 0 |
| 6 months - 5 years: Week 43 | 0 |
| 6 months - 5 years: Week 44 | 0 |
| 6 months - 5 years: Week 45 | 0 |
| 6 months - 5 years: Week 46 | 0 |
| 6 months - 5 years: Week 47 | 0 |
| 6 months - 5 years: Week 48 | 0 |
| 6-12 years: Week 37 | 0 |
| 6-12 years: Week 38 | 0 |
| 6-12 years: Week 39 | 0 |
| 6-12 years: Week 40 | 0 |
| 6-12 years: Week 41 | 0 |
| 6-12 years: Week 42 | 0 |
| 6-12 years: Week 43 | 0 |
| 6-12 years: Week 44 | 0 |
| 6-12 years: Week 45 | 0 |
| 6-12 years: Week 46 | 0 |
| 6-12 years: Week 47 | 0 |
| 6-12 years: Week 48 | 0 |
| 13-17 years: Week 37 | 0 |
| 13-17 years: Week 38 | 0 |
| 13-17 years: Week 39 | 0 |
| 13-17 years: Week 40 | 0 |
| 13-17 years: Week 41 | 0 |
| 13-17 years: Week 42 | 1 |
| 13-17 years: Week 43 | 0 |
| 13-17 years: Week 44 | 0 |
| 13-17 years: Week 45 | 0 |
| 13-17 years: Week 46 | 0 |
| 13-17 years: Week 47 | 0 |
| 13-17 years: Week 48 | 0 |
| 18-65 years: Week 37 | 0 |
| 18-65 years: Week 38 | 6 |
| 18-65 years: Week 39 | 15 |
| 18-65 years: Week 40 | 17 |
| 18-65 years: Week 41 | 3 |
| 18-65 years: Week 42 | 9 |
| 18-65 years: Week 43 | 0 |
| 18-65 years: Week 44 | 2 |
| 18-65 years: Week 45 | 5 |
| 18-65 years: Week 46 | 2 |
| 18-65 years: Week 47 | 0 |
| 18-65 years: Week 48 | 1 |
| >65 years: Week 37 | 0 |
| >65 years: Week 38 | 14 |
| >65 years: Week 39 | 32 |
| >65 years: Week 40 | 26 |
| >65 years: Week 41 | 22 |
| >65 years: Week 42 | 10 |
| >65 years: Week 43 | 3 |
| >65 years: Week 44 | 4 |
| >65 years: Week 45 | 4 |
| >65 years: Week 46 | 4 |
| >65 years: Week 47 | 2 |
| >65 years: Week 48 | 0 |
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| 6 months - 5 years: Week 37 | 0 |
| 6 months - 5 years: Week 38 | 0 |
| 6 months - 5 years: Week 39 | 0 |
| 6 months - 5 years: Week 40 | 0 |
| 6 months - 5 years: Week 41 | 0 |
| 6 months - 5 years: Week 42 | 0 |
| 6 months - 5 years: Week 43 | 0 |
| 6 months - 5 years: Week 44 | 0 |
| 6 months - 5 years: Week 45 | 0 |
| 6 months - 5 years: Week 46 | 0 |
| 6 months - 5 years: Week 47 | 0 |
| 6 months - 5 years: Week 48 | 0 |
| 6-12 years: Week 37 | 0 |
| 6-12 years: Week 38 | 0 |
| 6-12 years: Week 39 | 0 |
| 6-12 years: Week 40 | 0 |
| 6-12 years: Week 41 | 0 |
| 6-12 years: Week 42 | 0 |
| 6-12 years: Week 43 | 0 |
| 6-12 years: Week 44 | 0 |
| 6-12 years: Week 45 | 0 |
| 6-12 years: Week 46 | 0 |
| 6-12 years: Week 47 | 0 |
| 6-12 years: Week 48 | 0 |
| 13-17 years: Week 37 | 0 |
| 13-17 years: Week 38 | 0 |
| 13-17 years: Week 39 | 0 |
| 13-17 years: Week 40 | 0 |
| 13-17 years: Week 41 | 0 |
| 13-17 years: Week 42 | 1 |
| 13-17 years: Week 43 | 1 |
| 13-17 years: Week 44 | 1 |
| 13-17 years: Week 45 | 1 |
| 13-17 years: Week 46 | 1 |
| 13-17 years: Week 47 | 1 |
| 13-17 years: Week 48 | 1 |
| 18-65 years: Week 37 | 0 |
| 18-65 years: Week 38 | 6 |
| 18-65 years: Week 39 | 21 |
| 18-65 years: Week 40 | 38 |
| 18-65 years: Week 41 | 41 |
| 18-65 years: Week 42 | 50 |
| 18-65 years: Week 43 | 50 |
| 18-65 years: Week 44 | 52 |
| 18-65 years: Week 45 | 57 |
| 18-65 years: Week 46 | 59 |
| 18-65 years: Week 47 | 59 |
| 18-65 years: Week 48 | 60 |
| >65 years: Week 37 | 0 |
| >65 years: Week 38 | 14 |
| >65 years: Week 39 | 46 |
| >65 years: Week 40 | 72 |
| >65 years: Week 41 | 94 |
| >65 years: Week 42 | 104 |
| >65 years: Week 43 | 107 |
| >65 years: Week 44 | 111 |
| >65 years: Week 45 | 115 |
| >65 years: Week 46 | 119 |
| >65 years: Week 47 | 121 |
| >65 years: Week 48 | 121 |
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| 6 months - 5 years: Week 37 | 0 |
| 6 months - 5 years: Week 38 | 0 |
| 6 months - 5 years: Week 39 | 0 |
| 6 months - 5 years: Week 40 | 0 |
| 6 months - 5 years: Week 41 | 0 |
| 6 months - 5 years: Week 42 | 0 |
| 6 months - 5 years: Week 43 | 0 |
| 6 months - 5 years: Week 44 | 0 |
| 6 months - 5 years: Week 45 | 0 |
| 6 months - 5 years: Week 46 | 0 |
| 6 months - 5 years: Week 47 | 0 |
| 6 months - 5 years: Week 48 | 0 |
| 6-12 years: Week 37 | 0 |
| 6-12 years: Week 38 | 0 |
| 6-12 years: Week 39 | 0 |
| 6-12 years: Week 40 | 0 |
| 6-12 years: Week 41 | 0 |
| 6-12 years: Week 42 | 0 |
| 6-12 years: Week 43 | 0 |
| 6-12 years: Week 44 | 0 |
| 6-12 years: Week 45 | 0 |
| 6-12 years: Week 46 | 0 |
| 6-12 years: Week 47 | 0 |
| 6-12 years: Week 48 | 0 |
| 13-17 years: Week 37 | 0 |
| 13-17 years: Week 38 | 0 |
| 13-17 years: Week 39 | 0 |
| 13-17 years: Week 40 | 0 |
| 13-17 years: Week 41 | 0 |
| 13-17 years: Week 42 | 1 |
| 13-17 years: Week 43 | 0 |
| 13-17 years: Week 44 | 0 |
| 13-17 years: Week 45 | 0 |
| 13-17 years: Week 46 | 0 |
| 13-17 years: Week 47 | 0 |
| 13-17 years: Week 48 | 0 |
| 18-65 years: Week 37 | 0 |
| 18-65 years: Week 38 | 8 |
| 18-65 years: Week 39 | 25 |
| 18-65 years: Week 40 | 32 |
| 18-65 years: Week 41 | 17 |
| 18-65 years: Week 42 | 27 |
| 18-65 years: Week 43 | 9 |
| 18-65 years: Week 44 | 4 |
| 18-65 years: Week 45 | 10 |
| 18-65 years: Week 46 | 2 |
| 18-65 years: Week 47 | 1 |
| 18-65 years: Week 48 | 0 |
| >65 years: Week 37 | 0 |
| >65 years: Week 38 | 22 |
| >65 years: Week 39 | 75 |
| >65 years: Week 40 | 63 |
| >65 years: Week 41 | 47 |
| >65 years: Week 42 | 30 |
| >65 years: Week 43 | 13 |
| >65 years: Week 44 | 9 |
| >65 years: Week 45 | 9 |
| >65 years: Week 46 | 3 |
| >65 years: Week 47 | 1 |
| >65 years: Week 48 | 0 |
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| 6 months - 5 years: Week 37 | 0 |
| 6 months - 5 years: Week 38 | 0 |
| 6 months - 5 years: Week 39 | 0 |
| 6 months - 5 years: Week 40 | 0 |
| 6 months - 5 years: Week 41 | 0 |
| 6 months - 5 years: Week 42 | 0 |
| 6 months - 5 years: Week 43 | 0 |
| 6 months - 5 years: Week 44 | 0 |
| 6 months - 5 years: Week 45 | 0 |
| 6 months - 5 years: Week 46 | 0 |
| 6 months - 5 years: Week 47 | 0 |
| 6 months - 5 years: Week 48 | 0 |
| 6-12 years: Week 37 | 0 |
| 6-12 years: Week 38 | 0 |
| 6-12 years: Week 39 | 0 |
| 6-12 years: Week 40 | 0 |
| 6-12 years: Week 41 | 0 |
| 6-12 years: Week 42 | 0 |
| 6-12 years: Week 43 | 0 |
| 6-12 years: Week 44 | 0 |
| 6-12 years: Week 45 | 0 |
| 6-12 years: Week 46 | 0 |
| 6-12 years: Week 47 | 0 |
| 6-12 years: Week 48 | 0 |
| 13-17 years: Week 37 | 0 |
| 13-17 years: Week 38 | 0 |
| 13-17 years: Week 39 | 0 |
| 13-17 years: Week 40 | 0 |
| 13-17 years: Week 41 | 0 |
| 13-17 years: Week 42 | 1 |
| 13-17 years: Week 43 | 1 |
| 13-17 years: Week 44 | 1 |
| 13-17 years: Week 45 | 1 |
| 13-17 years: Week 46 | 1 |
| 13-17 years: Week 47 | 1 |
| 13-17 years: Week 48 | 1 |
| 18-65 years: Week 37 | 0 |
| 18-65 years: Week 38 | 8 |
| 18-65 years: Week 39 | 33 |
| 18-65 years: Week 40 | 65 |
| 18-65 years: Week 41 | 82 |
| 18-65 years: Week 42 | 109 |
| 18-65 years: Week 43 | 118 |
| 18-65 years: Week 44 | 122 |
| 18-65 years: Week 45 | 132 |
| 18-65 years: Week 46 | 134 |
| 18-65 years: Week 47 | 135 |
| 18-65 years: Week 48 | 135 |
| >65 years: Week 37 | 0 |
| >65 years: Week 38 | 22 |
| >65 years: Week 39 | 97 |
| >65 years: Week 40 | 160 |
| >65 years: Week 41 | 207 |
| >65 years: Week 42 | 237 |
| >65 years: Week 43 | 250 |
| >65 years: Week 44 | 259 |
| >65 years: Week 45 | 268 |
| >65 years: Week 46 | 271 |
| >65 years: Week 47 | 272 |
| >65 years: Week 48 | 272 |
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| 6 months - 5 years: Week 37 | 0 |
| 6 months - 5 years: Week 38 | 0 |
| 6 months - 5 years: Week 39 | 0 |
| 6 months - 5 years: Week 40 | 0 |
| 6 months - 5 years: Week 41 | 0 |
| 6 months - 5 years: Week 42 | 0 |
| 6 months - 5 years: Week 43 | 0 |
| 6 months - 5 years: Week 44 | 0 |
| 6 months - 5 years: Week 45 | 0 |
| 6 months - 5 years: Week 46 | 0 |
| 6 months - 5 years: Week 47 | 0 |
| 6 months - 5 years: Week 48 | 0 |
| 6-12 years: Week 37 | 0 |
| 6-12 years: Week 38 | 0 |
| 6-12 years: Week 39 | 0 |
| 6-12 years: Week 40 | 0 |
| 6-12 years: Week 41 | 0 |
| 6-12 years: Week 42 | 0 |
| 6-12 years: Week 43 | 0 |
| 6-12 years: Week 44 | 0 |
| 6-12 years: Week 45 | 0 |
| 6-12 years: Week 46 | 0 |
| 6-12 years: Week 47 | 0 |
| 6-12 years: Week 48 | 0 |
| 13-17 years: Week 37 | 0 |
| 13-17 years: Week 38 | 0 |
| 13-17 years: Week 39 | 0 |
| 13-17 years: Week 40 | 0 |
| 13-17 years: Week 41 | 0 |
| 13-17 years: Week 42 | 0 |
| 13-17 years: Week 43 | 0 |
| 13-17 years: Week 44 | 0 |
| 13-17 years: Week 45 | 0 |
| 13-17 years: Week 46 | 0 |
| 13-17 years: Week 47 | 0 |
| 13-17 years: Week 48 | 0 |
| 18-65 years: Week 37 | 0 |
| 18-65 years: Week 38 | 7 |
| 18-65 years: Week 39 | 9 |
| 18-65 years: Week 40 | 10 |
| 18-65 years: Week 41 | 7 |
| 18-65 years: Week 42 | 7 |
| 18-65 years: Week 43 | 3 |
| 18-65 years: Week 44 | 2 |
| 18-65 years: Week 45 | 3 |
| 18-65 years: Week 46 | 2 |
| 18-65 years: Week 47 | 0 |
| 18-65 years: Week 48 | 1 |
| >65 years: Week 37 | 0 |
| >65 years: Week 38 | 8 |
| >65 years: Week 39 | 20 |
| >65 years: Week 40 | 19 |
| >65 years: Week 41 | 14 |
| >65 years: Week 42 | 11 |
| >65 years: Week 43 | 3 |
| >65 years: Week 44 | 2 |
| >65 years: Week 45 | 2 |
| >65 years: Week 46 | 1 |
| >65 years: Week 47 | 0 |
| >65 years: Week 48 | 0 |
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| 6 months - 5 years: Week 37 | 0 |
| 6 months - 5 years: Week 38 | 0 |
| 6 months - 5 years: Week 39 | 0 |
| 6 months - 5 years: Week 40 | 0 |
| 6 months - 5 years: Week 41 | 0 |
| 6 months - 5 years: Week 42 | 0 |
| 6 months - 5 years: Week 43 | 0 |
| 6 months - 5 years: Week 44 | 0 |
| 6 months - 5 years: Week 45 | 0 |
| 6 months - 5 years: Week 46 | 0 |
| 6 months - 5 years: Week 47 | 0 |
| 6 months - 5 years: Week 48 | 0 |
| 6-12 years: Week 37 | 0 |
| 6-12 years: Week 38 | 0 |
| 6-12 years: Week 39 | 0 |
| 6-12 years: Week 40 | 0 |
| 6-12 years: Week 41 | 0 |
| 6-12 years: Week 42 | 0 |
| 6-12 years: Week 43 | 0 |
| 6-12 years: Week 44 | 0 |
| 6-12 years: Week 45 | 0 |
| 6-12 years: Week 46 | 0 |
| 6-12 years: Week 47 | 0 |
| 6-12 years: Week 48 | 0 |
| 13-17 years: Week 37 | 0 |
| 13-17 years: Week 38 | 0 |
| 13-17 years: Week 39 | 0 |
| 13-17 years: Week 40 | 0 |
| 13-17 years: Week 41 | 0 |
| 13-17 years: Week 42 | 0 |
| 13-17 years: Week 43 | 0 |
| 13-17 years: Week 44 | 0 |
| 13-17 years: Week 45 | 0 |
| 13-17 years: Week 46 | 0 |
| 13-17 years: Week 47 | 0 |
| 13-17 years: Week 48 | 0 |
| 18-65 years: Week 37 | 0 |
| 18-65 years: Week 38 | 7 |
| 18-65 years: Week 39 | 16 |
| 18-65 years: Week 40 | 26 |
| 18-65 years: Week 41 | 33 |
| 18-65 years: Week 42 | 40 |
| 18-65 years: Week 43 | 43 |
| 18-65 years: Week 44 | 45 |
| 18-65 years: Week 45 | 48 |
| 18-65 years: Week 46 | 50 |
| 18-65 years: Week 47 | 50 |
| 18-65 years: Week 48 | 51 |
| >65 years: Week 37 | 0 |
| >65 years: Week 38 | 8 |
| >65 years: Week 39 | 28 |
| >65 years: Week 40 | 47 |
| >65 years: Week 41 | 61 |
| >65 years: Week 42 | 72 |
| >65 years: Week 43 | 75 |
| >65 years: Week 44 | 77 |
| >65 years: Week 45 | 79 |
| >65 years: Week 46 | 80 |
| >65 years: Week 47 | 80 |
| >65 years: Week 48 | 80 |
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| 6 months - 5 years: Week 37 | 0 |
| 6 months - 5 years: Week 38 | 0 |
| 6 months - 5 years: Week 39 | 0 |
| 6 months - 5 years: Week 40 | 0 |
| 6 months - 5 years: Week 41 | 0 |
| 6 months - 5 years: Week 42 | 0 |
| 6 months - 5 years: Week 43 | 0 |
| 6 months - 5 years: Week 44 | 0 |
| 6 months - 5 years: Week 45 | 0 |
| 6 months - 5 years: Week 46 | 0 |
| 6 months - 5 years: Week 47 | 0 |
| 6 months - 5 years: Week 48 | 0 |
| 6-12 years: Week 37 | 0 |
| 6-12 years: Week 38 | 0 |
| 6-12 years: Week 39 | 0 |
| 6-12 years: Week 40 | 0 |
| 6-12 years: Week 41 | 0 |
| 6-12 years: Week 42 | 0 |
| 6-12 years: Week 43 | 0 |
| 6-12 years: Week 44 | 0 |
| 6-12 years: Week 45 | 0 |
| 6-12 years: Week 46 | 0 |
| 6-12 years: Week 47 | 0 |
| 6-12 years: Week 48 | 0 |
| 13-17 years: Week 37 | 0 |
| 13-17 years: Week 38 | 0 |
| 13-17 years: Week 39 | 0 |
| 13-17 years: Week 40 | 0 |
| 13-17 years: Week 41 | 0 |
| 13-17 years: Week 42 | 0 |
| 13-17 years: Week 43 | 0 |
| 13-17 years: Week 44 | 0 |
| 13-17 years: Week 45 | 0 |
| 13-17 years: Week 46 | 0 |
| 13-17 years: Week 47 | 0 |
| 13-17 years: Week 48 | 0 |
| 18-65 years: Week 37 | 0 |
| 18-65 years: Week 38 | 0 |
| 18-65 years: Week 39 | 0 |
| 18-65 years: Week 40 | 2 |
| 18-65 years: Week 41 | 0 |
| 18-65 years: Week 42 | 1 |
| 18-65 years: Week 43 | 0 |
| 18-65 years: Week 44 | 1 |
| 18-65 years: Week 45 | 0 |
| 18-65 years: Week 46 | 0 |
| 18-65 years: Week 47 | 0 |
| 18-65 years: Week 48 | 0 |
| >65 years: Week 37 | 0 |
| >65 years: Week 38 | 0 |
| >65 years: Week 39 | 0 |
| >65 years: Week 40 | 1 |
| >65 years: Week 41 | 0 |
| >65 years: Week 42 | 1 |
| >65 years: Week 43 | 0 |
| >65 years: Week 44 | 0 |
| >65 years: Week 45 | 1 |
| >65 years: Week 46 | 0 |
| >65 years: Week 47 | 0 |
| >65 years: Week 48 | 0 |
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| 6 months - 5 years: Week 37 | 0 |
| 6 months - 5 years: Week 38 | 0 |
| 6 months - 5 years: Week 39 | 0 |
| 6 months - 5 years: Week 40 | 0 |
| 6 months - 5 years: Week 41 | 0 |
| 6 months - 5 years: Week 42 | 0 |
| 6 months - 5 years: Week 43 | 0 |
| 6 months - 5 years: Week 44 | 0 |
| 6 months - 5 years: Week 45 | 0 |
| 6 months - 5 years: Week 46 | 0 |
| 6 months - 5 years: Week 47 | 0 |
| 6 months - 5 years: Week 48 | 0 |
| 6-12 years: Week 37 | 0 |
| 6-12 years: Week 38 | 0 |
| 6-12 years: Week 39 | 0 |
| 6-12 years: Week 40 | 0 |
| 6-12 years: Week 41 | 0 |
| 6-12 years: Week 42 | 0 |
| 6-12 years: Week 43 | 0 |
| 6-12 years: Week 44 | 0 |
| 6-12 years: Week 45 | 0 |
| 6-12 years: Week 46 | 0 |
| 6-12 years: Week 47 | 0 |
| 6-12 years: Week 48 | 0 |
| 13-17 years: Week 37 | 0 |
| 13-17 years: Week 38 | 0 |
| 13-17 years: Week 39 | 0 |
| 13-17 years: Week 40 | 0 |
| 13-17 years: Week 41 | 0 |
| 13-17 years: Week 42 | 0 |
| 13-17 years: Week 43 | 0 |
| 13-17 years: Week 44 | 0 |
| 13-17 years: Week 45 | 0 |
| 13-17 years: Week 46 | 0 |
| 13-17 years: Week 47 | 0 |
| 13-17 years: Week 48 | 0 |
| 18-65 years: Week 37 | 0 |
| 18-65 years: Week 38 | 0 |
| 18-65 years: Week 39 | 0 |
| 18-65 years: Week 40 | 2 |
| 18-65 years: Week 41 | 2 |
| 18-65 years: Week 42 | 3 |
| 18-65 years: Week 43 | 3 |
| 18-65 years: Week 44 | 4 |
| 18-65 years: Week 45 | 4 |
| 18-65 years: Week 46 | 4 |
| 18-65 years: Week 47 | 4 |
| 18-65 years: Week 48 | 4 |
| >65 years: Week 37 | 0 |
| >65 years: Week 38 | 0 |
| >65 years: Week 39 | 0 |
| >65 years: Week 40 | 1 |
| >65 years: Week 41 | 1 |
| >65 years: Week 42 | 2 |
| >65 years: Week 43 | 2 |
| >65 years: Week 44 | 2 |
| >65 years: Week 45 | 3 |
| >65 years: Week 46 | 3 |
| >65 years: Week 47 | 3 |
| >65 years: Week 48 | 3 |
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| 6 months - 5 years: Week 37 | 0 |
| 6 months - 5 years: Week 38 | 0 |
| 6 months - 5 years: Week 39 | 0 |
| 6 months - 5 years: Week 40 | 0 |
| 6 months - 5 years: Week 41 | 0 |
| 6 months - 5 years: Week 42 | 0 |
| 6 months - 5 years: Week 43 | 0 |
| 6 months - 5 years: Week 44 | 0 |
| 6 months - 5 years: Week 45 | 0 |
| 6 months - 5 years: Week 46 | 0 |
| 6 months - 5 years: Week 47 | 0 |
| 6 months - 5 years: Week 48 | 0 |
| 6-12 years: Week 37 | 0 |
| 6-12 years: Week 38 | 0 |
| 6-12 years: Week 39 | 0 |
| 6-12 years: Week 40 | 0 |
| 6-12 years: Week 41 | 0 |
| 6-12 years: Week 42 | 0 |
| 6-12 years: Week 43 | 0 |
| 6-12 years: Week 44 | 0 |
| 6-12 years: Week 45 | 0 |
| 6-12 years: Week 46 | 0 |
| 6-12 years: Week 47 | 0 |
| 6-12 years: Week 48 | 0 |
| 13-17 years: Week 37 | 0 |
| 13-17 years: Week 38 | 0 |
| 13-17 years: Week 39 | 0 |
| 13-17 years: Week 40 | 0 |
| 13-17 years: Week 41 | 0 |
| 13-17 years: Week 42 | 0 |
| 13-17 years: Week 43 | 0 |
| 13-17 years: Week 44 | 0 |
| 13-17 years: Week 45 | 0 |
| 13-17 years: Week 46 | 0 |
| 13-17 years: Week 47 | 0 |
| 13-17 years: Week 48 | 0 |
| 18-65 years: Week 37 | 0 |
| 18-65 years: Week 38 | 0 |
| 18-65 years: Week 39 | 0 |
| 18-65 years: Week 40 | 2 |
| 18-65 years: Week 41 | 0 |
| 18-65 years: Week 42 | 2 |
| 18-65 years: Week 43 | 1 |
| 18-65 years: Week 44 | 0 |
| 18-65 years: Week 45 | 0 |
| 18-65 years: Week 46 | 1 |
| 18-65 years: Week 47 | 0 |
| 18-65 years: Week 48 | 0 |
| >65 years: Week 37 | 0 |
| >65 years: Week 38 | 1 |
| >65 years: Week 39 | 0 |
| >65 years: Week 40 | 3 |
| >65 years: Week 41 | 1 |
| >65 years: Week 42 | 1 |
| >65 years: Week 43 | 2 |
| >65 years: Week 44 | 1 |
| >65 years: Week 45 | 1 |
| >65 years: Week 46 | 1 |
| >65 years: Week 47 | 0 |
| >65 years: Week 48 | 0 |
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| 6 months - 5 years: Week 37 | 0 |
| 6 months - 5 years: Week 38 | 0 |
| 6 months - 5 years: Week 39 | 0 |
| 6 months - 5 years: Week 40 | 0 |
| 6 months - 5 years: Week 41 | 0 |
| 6 months - 5 years: Week 42 | 0 |
| 6 months - 5 years: Week 43 | 0 |
| 6 months - 5 years: Week 44 | 0 |
| 6 months - 5 years: Week 45 | 0 |
| 6 months - 5 years: Week 46 | 0 |
| 6 months - 5 years: Week 47 | 0 |
| 6 months - 5 years: Week 48 | 0 |
| 6-12 years: Week 37 | 0 |
| 6-12 years: Week 38 | 0 |
| 6-12 years: Week 39 | 0 |
| 6-12 years: Week 40 | 0 |
| 6-12 years: Week 41 | 0 |
| 6-12 years: Week 42 | 0 |
| 6-12 years: Week 43 | 0 |
| 6-12 years: Week 44 | 0 |
| 6-12 years: Week 45 | 0 |
| 6-12 years: Week 46 | 0 |
| 6-12 years: Week 47 | 0 |
| 6-12 years: Week 48 | 0 |
| 13-17 years: Week 37 | 0 |
| 13-17 years: Week 38 | 0 |
| 13-17 years: Week 39 | 0 |
| 13-17 years: Week 40 | 0 |
| 13-17 years: Week 41 | 0 |
| 13-17 years: Week 42 | 0 |
| 13-17 years: Week 43 | 0 |
| 13-17 years: Week 44 | 0 |
| 13-17 years: Week 45 | 0 |
| 13-17 years: Week 46 | 0 |
| 13-17 years: Week 47 | 0 |
| 13-17 years: Week 48 | 0 |
| 18-65 years: Week 37 | 0 |
| 18-65 years: Week 38 | 0 |
| 18-65 years: Week 39 | 0 |
| 18-65 years: Week 40 | 2 |
| 18-65 years: Week 41 | 2 |
| 18-65 years: Week 42 | 4 |
| 18-65 years: Week 43 | 5 |
| 18-65 years: Week 44 | 5 |
| 18-65 years: Week 45 | 5 |
| 18-65 years: Week 46 | 6 |
| 18-65 years: Week 47 | 6 |
| 18-65 years: Week 48 | 6 |
| >65 years: Week 37 | 0 |
| >65 years: Week 38 | 1 |
| >65 years: Week 39 | 1 |
| >65 years: Week 40 | 4 |
| >65 years: Week 41 | 5 |
| >65 years: Week 42 | 6 |
| >65 years: Week 43 | 8 |
| >65 years: Week 44 | 9 |
| >65 years: Week 45 | 10 |
| >65 years: Week 46 | 11 |
| >65 years: Week 47 | 11 |
| >65 years: Week 48 | 11 |
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| 6 months - 5 years: Week 37 | 0 |
| 6 months - 5 years: Week 38 | 0 |
| 6 months - 5 years: Week 39 | 0 |
| 6 months - 5 years: Week 40 | 0 |
| 6 months - 5 years: Week 41 | 0 |
| 6 months - 5 years: Week 42 | 0 |
| 6 months - 5 years: Week 43 | 0 |
| 6 months - 5 years: Week 44 | 0 |
| 6 months - 5 years: Week 45 | 0 |
| 6 months - 5 years: Week 46 | 0 |
| 6 months - 5 years: Week 47 | 0 |
| 6 months - 5 years: Week 48 | 0 |
| 6-12 years: Week 37 | 0 |
| 6-12 years: Week 38 | 0 |
| 6-12 years: Week 39 | 0 |
| 6-12 years: Week 40 | 0 |
| 6-12 years: Week 41 | 0 |
| 6-12 years: Week 42 | 0 |
| 6-12 years: Week 43 | 0 |
| 6-12 years: Week 44 | 0 |
| 6-12 years: Week 45 | 0 |
| 6-12 years: Week 46 | 0 |
| 6-12 years: Week 47 | 0 |
| 6-12 years: Week 48 | 0 |
| 13-17 years: Week 37 | 0 |
| 13-17 years: Week 38 | 0 |
| 13-17 years: Week 39 | 0 |
| 13-17 years: Week 40 | 0 |
| 13-17 years: Week 41 | 0 |
| 13-17 years: Week 42 | 0 |
| 13-17 years: Week 43 | 0 |
| 13-17 years: Week 44 | 0 |
| 13-17 years: Week 45 | 0 |
| 13-17 years: Week 46 | 0 |
| 13-17 years: Week 47 | 0 |
| 13-17 years: Week 48 | 0 |
| 18-65 years: Week 37 | 0 |
| 18-65 years: Week 38 | 11 |
| 18-65 years: Week 39 | 18 |
| 18-65 years: Week 40 | 22 |
| 18-65 years: Week 41 | 12 |
| 18-65 years: Week 42 | 18 |
| 18-65 years: Week 43 | 5 |
| 18-65 years: Week 44 | 3 |
| 18-65 years: Week 45 | 7 |
| 18-65 years: Week 46 | 3 |
| 18-65 years: Week 47 | 1 |
| 18-65 years: Week 48 | 0 |
| >65 years: Week 37 | 0 |
| >65 years: Week 38 | 16 |
| >65 years: Week 39 | 42 |
| >65 years: Week 40 | 42 |
| >65 years: Week 41 | 20 |
| >65 years: Week 42 | 15 |
| >65 years: Week 43 | 2 |
| >65 years: Week 44 | 6 |
| >65 years: Week 45 | 6 |
| >65 years: Week 46 | 4 |
| >65 years: Week 47 | 1 |
| >65 years: Week 48 | 1 |
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| 6 months - 5 years: Week 37 | 0 |
| 6 months - 5 years: Week 38 | 0 |
| 6 months - 5 years: Week 39 | 0 |
| 6 months - 5 years: Week 40 | 0 |
| 6 months - 5 years: Week 41 | 0 |
| 6 months - 5 years: Week 42 | 0 |
| 6 months - 5 years: Week 43 | 0 |
| 6 months - 5 years: Week 44 | 0 |
| 6 months - 5 years: Week 45 | 0 |
| 6 months - 5 years: Week 46 | 0 |
| 6 months - 5 years: Week 47 | 0 |
| 6 months - 5 years: Week 48 | 0 |
| 6-12 years: Week 37 | 0 |
| 6-12 years: Week 38 | 0 |
| 6-12 years: Week 39 | 0 |
| 6-12 years: Week 40 | 0 |
| 6-12 years: Week 41 | 0 |
| 6-12 years: Week 42 | 0 |
| 6-12 years: Week 43 | 0 |
| 6-12 years: Week 44 | 0 |
| 6-12 years: Week 45 | 0 |
| 6-12 years: Week 46 | 0 |
| 6-12 years: Week 47 | 0 |
| 6-12 years: Week 48 | 0 |
| 13-17 years: Week 37 | 0 |
| 13-17 years: Week 38 | 0 |
| 13-17 years: Week 39 | 0 |
| 13-17 years: Week 40 | 0 |
| 13-17 years: Week 41 | 0 |
| 13-17 years: Week 42 | 0 |
| 13-17 years: Week 43 | 0 |
| 13-17 years: Week 44 | 0 |
| 13-17 years: Week 45 | 0 |
| 13-17 years: Week 46 | 0 |
| 13-17 years: Week 47 | 0 |
| 13-17 years: Week 48 | 0 |
| 18-65 years: Week 37 | 0 |
| 18-65 years: Week 38 | 11 |
| 18-65 years: Week 39 | 29 |
| 18-65 years: Week 40 | 51 |
| 18-65 years: Week 41 | 63 |
| 18-65 years: Week 42 | 81 |
| 18-65 years: Week 43 | 86 |
| 18-65 years: Week 44 | 89 |
| 18-65 years: Week 45 | 96 |
| 18-65 years: Week 46 | 99 |
| 18-65 years: Week 47 | 100 |
| 18-65 years: Week 48 | 100 |
| >65 years: Week 37 | 0 |
| >65 years: Week 38 | 16 |
| >65 years: Week 39 | 58 |
| >65 years: Week 40 | 100 |
| >65 years: Week 41 | 120 |
| >65 years: Week 42 | 135 |
| >65 years: Week 43 | 137 |
| >65 years: Week 44 | 143 |
| >65 years: Week 45 | 149 |
| >65 years: Week 46 | 153 |
| >65 years: Week 47 | 154 |
| >65 years: Week 48 | 155 |
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| 6 months - 5 years: Week 37 | 0 |
| 6 months - 5 years: Week 38 | 0 |
| 6 months - 5 years: Week 39 | 0 |
| 6 months - 5 years: Week 40 | 0 |
| 6 months - 5 years: Week 41 | 0 |
| 6 months - 5 years: Week 42 | 0 |
| 6 months - 5 years: Week 43 | 0 |
| 6 months - 5 years: Week 44 | 0 |
| 6 months - 5 years: Week 45 | 0 |
| 6 months - 5 years: Week 46 | 0 |
| 6 months - 5 years: Week 47 | 0 |
| 6 months - 5 years: Week 48 | 0 |
| 6-12 years: Week 37 | 0 |
| 6-12 years: Week 38 | 0 |
| 6-12 years: Week 39 | 0 |
| 6-12 years: Week 40 | 0 |
| 6-12 years: Week 41 | 0 |
| 6-12 years: Week 42 | 0 |
| 6-12 years: Week 43 | 0 |
| 6-12 years: Week 44 | 0 |
| 6-12 years: Week 45 | 0 |
| 6-12 years: Week 46 | 0 |
| 6-12 years: Week 47 | 0 |
| 6-12 years: Week 48 | 0 |
| 13-17 years: Week 37 | 0 |
| 13-17 years: Week 38 | 0 |
| 13-17 years: Week 39 | 0 |
| 13-17 years: Week 40 | 0 |
| 13-17 years: Week 41 | 0 |
| 13-17 years: Week 42 | 0 |
| 13-17 years: Week 43 | 0 |
| 13-17 years: Week 44 | 0 |
| 13-17 years: Week 45 | 0 |
| 13-17 years: Week 46 | 0 |
| 13-17 years: Week 47 | 0 |
| 13-17 years: Week 48 | 0 |
| 18-65 years: Week 37 | 0 |
| 18-65 years: Week 38 | 9 |
| 18-65 years: Week 39 | 20 |
| 18-65 years: Week 40 | 17 |
| 18-65 years: Week 41 | 8 |
| 18-65 years: Week 42 | 8 |
| 18-65 years: Week 43 | 6 |
| 18-65 years: Week 44 | 1 |
| 18-65 years: Week 45 | 7 |
| 18-65 years: Week 46 | 1 |
| 18-65 years: Week 47 | 0 |
| 18-65 years: Week 48 | 1 |
| >65 years: Week 37 | 0 |
| >65 years: Week 38 | 10 |
| >65 years: Week 39 | 28 |
| >65 years: Week 40 | 25 |
| >65 years: Week 41 | 17 |
| >65 years: Week 42 | 7 |
| >65 years: Week 43 | 4 |
| >65 years: Week 44 | 4 |
| >65 years: Week 45 | 3 |
| >65 years: Week 46 | 2 |
| >65 years: Week 47 | 0 |
| >65 years: Week 48 | 0 |
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| 6 months - 5 years: Week 37 | 0 |
| 6 months - 5 years: Week 38 | 0 |
| 6 months - 5 years: Week 39 | 0 |
| 6 months - 5 years: Week 40 | 0 |
| 6 months - 5 years: Week 41 | 0 |
| 6 months - 5 years: Week 42 | 0 |
| 6 months - 5 years: Week 43 | 0 |
| 6 months - 5 years: Week 44 | 0 |
| 6 months - 5 years: Week 45 | 0 |
| 6 months - 5 years: Week 46 | 0 |
| 6 months - 5 years: Week 47 | 0 |
| 6 months - 5 years: Week 48 | 0 |
| 6-12 years: Week 37 | 0 |
| 6-12 years: Week 38 | 0 |
| 6-12 years: Week 39 | 0 |
| 6-12 years: Week 40 | 0 |
| 6-12 years: Week 41 | 0 |
| 6-12 years: Week 42 | 0 |
| 6-12 years: Week 43 | 0 |
| 6-12 years: Week 44 | 0 |
| 6-12 years: Week 45 | 0 |
| 6-12 years: Week 46 | 0 |
| 6-12 years: Week 47 | 0 |
| 6-12 years: Week 48 | 0 |
| 13-17 years: Week 37 | 0 |
| 13-17 years: Week 38 | 0 |
| 13-17 years: Week 39 | 0 |
| 13-17 years: Week 40 | 0 |
| 13-17 years: Week 41 | 0 |
| 13-17 years: Week 42 | 0 |
| 13-17 years: Week 43 | 0 |
| 13-17 years: Week 44 | 0 |
| 13-17 years: Week 45 | 0 |
| 13-17 years: Week 46 | 0 |
| 13-17 years: Week 47 | 0 |
| 13-17 years: Week 48 | 0 |
| 18-65 years: Week 37 | 0 |
| 18-65 years: Week 38 | 9 |
| 18-65 years: Week 39 | 29 |
| 18-65 years: Week 40 | 46 |
| 18-65 years: Week 41 | 54 |
| 18-65 years: Week 42 | 62 |
| 18-65 years: Week 43 | 68 |
| 18-65 years: Week 44 | 69 |
| 18-65 years: Week 45 | 76 |
| 18-65 years: Week 46 | 77 |
| 18-65 years: Week 47 | 77 |
| 18-65 years: Week 48 | 78 |
| >65 years: Week 37 | 0 |
| >65 years: Week 38 | 10 |
| >65 years: Week 39 | 38 |
| >65 years: Week 40 | 63 |
| >65 years: Week 41 | 80 |
| >65 years: Week 42 | 87 |
| >65 years: Week 43 | 91 |
| >65 years: Week 44 | 95 |
| >65 years: Week 45 | 98 |
| >65 years: Week 46 | 100 |
| >65 years: Week 47 | 100 |
| >65 years: Week 48 | 100 |
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| At Risk: Week 37 | 0 |
| At Risk: Week 38 | 62 |
| At Risk: Week 39 | 159 |
| At Risk: Week 40 | 151 |
| At Risk: Week 41 | 102 |
| At Risk: Week 42 | 74 |
| At Risk: Week 43 | 29 |
| At Risk: Week 44 | 28 |
| At Risk: Week 45 | 25 |
| At Risk: Week 46 | 11 |
| At Risk: Week 47 | 2 |
| At Risk: Week 48 | 1 |
| Not at risk: Week 37 | 0 |
| Not at risk: Week 38 | 5 |
| Not at risk: Week 39 | 10 |
| Not at risk: Week 40 | 13 |
| Not at risk: Week 41 | 10 |
| Not at risk: Week 42 | 11 |
| Not at risk: Week 43 | 0 |
| Not at risk: Week 44 | 3 |
| Not at risk: Week 45 | 3 |
| Not at risk: Week 46 | 2 |
| Not at risk: Week 47 | 1 |
| Not at risk: Week 48 | 1 |
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| At risk: Week 37 | 0 |
| At risk: Week 38 | 62 |
| At risk: Week 39 | 221 |
| At risk: Week 40 | 372 |
| At risk: Week 41 | 474 |
| At risk: Week 42 | 548 |
| At risk: Week 43 | 577 |
| At risk: Week 44 | 605 |
| At risk: Week 45 | 630 |
| At risk: Week 46 | 641 |
| At risk: Week 47 | 643 |
| At risk: Week 48 | 644 |
| Not at risk: Week 37 | 0 |
| Not at risk: Week 38 | 5 |
| Not at risk: Week 39 | 15 |
| Not at risk: Week 40 | 28 |
| Not at risk: Week 41 | 38 |
| Not at risk: Week 42 | 49 |
| Not at risk: Week 43 | 49 |
| Not at risk: Week 44 | 52 |
| Not at risk: Week 45 | 55 |
| Not at risk: Week 46 | 57 |
| Not at risk: Week 47 | 58 |
| Not at risk: Week 48 | 59 |
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| At risk: Week 37 | 0 |
| At risk: Week 38 | 4 |
| At risk: Week 39 | 15 |
| At risk: Week 40 | 8 |
| At risk: Week 41 | 8 |
| At risk: Week 42 | 8 |
| At risk: Week 43 | 3 |
| At risk: Week 44 | 2 |
| At risk: Week 45 | 3 |
| At risk: Week 46 | 4 |
| At risk: Week 47 | 0 |
| At risk: Week 48 | 0 |
| Not at risk: Week 37 | 0 |
| Not at risk: Week 38 | 0 |
| Not at risk: Week 39 | 0 |
| Not at risk: Week 40 | 0 |
| Not at risk: Week 41 | 2 |
| Not at risk: Week 42 | 1 |
| Not at risk: Week 43 | 0 |
| Not at risk: Week 44 | 0 |
| Not at risk: Week 45 | 0 |
| Not at risk: Week 46 | 0 |
| Not at risk: Week 47 | 0 |
| Not at risk: Week 48 | 0 |
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| At risk: Week 37 | 0 |
| At risk: Week 38 | 4 |
| At risk: Week 39 | 19 |
| At risk: Week 40 | 27 |
| At risk: Week 41 | 35 |
| At risk: Week 42 | 43 |
| At risk: Week 43 | 46 |
| At risk: Week 44 | 48 |
| At risk: Week 45 | 51 |
| At risk: Week 46 | 55 |
| At risk: Week 47 | 55 |
| At risk: Week 48 | 55 |
| Not at risk: Week 37 | 0 |
| Not at risk: Week 38 | 0 |
| Not at risk: Week 39 | 0 |
| Not at risk: Week 40 | 0 |
| Not at risk: Week 41 | 2 |
| Not at risk: Week 42 | 3 |
| Not at risk: Week 43 | 3 |
| Not at risk: Week 44 | 3 |
| Not at risk: Week 45 | 3 |
| Not at risk: Week 46 | 3 |
| Not at risk: Week 47 | 3 |
| Not at risk: Week 48 | 3 |
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| At risk: Week 37 | 0 |
| At risk: Week 38 | 14 |
| At risk: Week 39 | 19 |
| At risk: Week 40 | 21 |
| At risk: Week 41 | 26 |
| At risk: Week 42 | 13 |
| At risk: Week 43 | 6 |
| At risk: Week 44 | 5 |
| At risk: Week 45 | 8 |
| At risk: Week 46 | 2 |
| At risk: Week 47 | 0 |
| At risk: Week 48 | 0 |
| Not at risk: Week 37 | 0 |
| Not at risk: Week 38 | 2 |
| Not at risk: Week 39 | 1 |
| Not at risk: Week 40 | 3 |
| Not at risk: Week 41 | 2 |
| Not at risk: Week 42 | 2 |
| Not at risk: Week 43 | 0 |
| Not at risk: Week 44 | 2 |
| Not at risk: Week 45 | 0 |
| Not at risk: Week 46 | 1 |
| Not at risk: Week 47 | 0 |
| Not at risk: Week 48 | 0 |
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| At risk: Week 37 | 0 |
| At risk: Week 38 | 14 |
| At risk: Week 39 | 33 |
| At risk: Week 40 | 54 |
| At risk: Week 41 | 80 |
| At risk: Week 42 | 93 |
| At risk: Week 43 | 99 |
| At risk: Week 44 | 104 |
| At risk: Week 45 | 112 |
| At risk: Week 46 | 114 |
| At risk: Week 47 | 114 |
| At risk: Week 48 | 114 |
| Not at risk: Week 37 | 0 |
| Not at risk: Week 38 | 2 |
| Not at risk: Week 39 | 3 |
| Not at risk: Week 40 | 6 |
| Not at risk: Week 41 | 8 |
| Not at risk: Week 42 | 10 |
| Not at risk: Week 43 | 10 |
| Not at risk: Week 44 | 12 |
| Not at risk: Week 45 | 12 |
| Not at risk: Week 46 | 13 |
| Not at risk: Week 47 | 13 |
| Not at risk: Week 48 | 13 |
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| At risk: Week 37 | 0 |
| At risk: Week 38 | 18 |
| At risk: Week 39 | 42 |
| At risk: Week 40 | 41 |
| At risk: Week 41 | 25 |
| At risk: Week 42 | 18 |
| At risk: Week 43 | 3 |
| At risk: Week 44 | 6 |
| At risk: Week 45 | 7 |
| At risk: Week 46 | 5 |
| At risk: Week 47 | 2 |
| At risk: Week 48 | 0 |
| Not at risk: Week 37 | 0 |
| Not at risk: Week 38 | 2 |
| Not at risk: Week 39 | 5 |
| Not at risk: Week 40 | 2 |
| Not at risk: Week 41 | 0 |
| Not at risk: Week 42 | 2 |
| Not at risk: Week 43 | 0 |
| Not at risk: Week 44 | 0 |
| Not at risk: Week 45 | 2 |
| Not at risk: Week 46 | 1 |
| Not at risk: Week 47 | 0 |
| Not at risk: Week 48 | 1 |
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| At risk: Week 37 | 0 |
| At risk: Week 38 | 18 |
| At risk: Week 39 | 60 |
| At risk: Week 40 | 101 |
| At risk: Week 41 | 126 |
| At risk: Week 42 | 144 |
| At risk: Week 43 | 147 |
| At risk: Week 44 | 153 |
| At risk: Week 45 | 160 |
| At risk: Week 46 | 165 |
| At risk: Week 47 | 167 |
| At risk: Week 48 | 167 |
| Not at risk: Week 37 | 0 |
| Not at risk: Week 38 | 2 |
| Not at risk: Week 39 | 7 |
| Not at risk: Week 40 | 9 |
| Not at risk: Week 41 | 9 |
| Not at risk: Week 42 | 11 |
| Not at risk: Week 43 | 11 |
| Not at risk: Week 44 | 11 |
| Not at risk: Week 45 | 13 |
| Not at risk: Week 46 | 14 |
| Not at risk: Week 47 | 14 |
| Not at risk: Week 48 | 15 |
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| At risk: Week 37 | 0 |
| At risk: Week 38 | 28 |
| At risk: Week 39 | 94 |
| At risk: Week 40 | 88 |
| At risk: Week 41 | 62 |
| At risk: Week 42 | 49 |
| At risk: Week 43 | 22 |
| At risk: Week 44 | 12 |
| At risk: Week 45 | 16 |
| At risk: Week 46 | 5 |
| At risk: Week 47 | 1 |
| At risk: Week 48 | 0 |
| Not at risk: Week 37 | 0 |
| Not at risk: Week 38 | 2 |
| Not at risk: Week 39 | 6 |
| Not at risk: Week 40 | 7 |
| Not at risk: Week 41 | 2 |
| Not at risk: Week 42 | 9 |
| Not at risk: Week 43 | 0 |
| Not at risk: Week 44 | 1 |
| Not at risk: Week 45 | 3 |
| Not at risk: Week 46 | 0 |
| Not at risk: Week 47 | 1 |
| Not at risk: Week 48 | 0 |
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| At risk: Week 37 | 0 |
| At risk: Week 38 | 28 |
| At risk: Week 39 | 122 |
| At risk: Week 40 | 210 |
| At risk: Week 41 | 272 |
| At risk: Week 42 | 321 |
| At risk: Week 43 | 343 |
| At risk: Week 44 | 355 |
| At risk: Week 45 | 371 |
| At risk: Week 46 | 376 |
| At risk: Week 47 | 377 |
| At risk: Week 48 | 377 |
| Not at risk: Week 37 | 0 |
| Not at risk: Week 38 | 2 |
| Not at risk: Week 39 | 8 |
| Not at risk: Week 40 | 15 |
| Not at risk: Week 41 | 17 |
| Not at risk: Week 42 | 26 |
| Not at risk: Week 43 | 26 |
| Not at risk: Week 44 | 27 |
| Not at risk: Week 45 | 30 |
| Not at risk: Week 46 | 30 |
| Not at risk: Week 47 | 31 |
| Not at risk: Week 48 | 31 |
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| At risk: Week 37 | 0 |
| At risk: Week 38 | 13 |
| At risk: Week 39 | 27 |
| At risk: Week 40 | 28 |
| At risk: Week 41 | 18 |
| At risk: Week 42 | 17 |
| At risk: Week 43 | 6 |
| At risk: Week 44 | 4 |
| At risk: Week 45 | 5 |
| At risk: Week 46 | 3 |
| At risk: Week 47 | 0 |
| At risk: Week 48 | 0 |
| Not at risk: Week 37 | 0 |
| Not at risk: Week 38 | 2 |
| Not at risk: Week 39 | 2 |
| Not at risk: Week 40 | 1 |
| Not at risk: Week 41 | 3 |
| Not at risk: Week 42 | 1 |
| Not at risk: Week 43 | 0 |
| Not at risk: Week 44 | 0 |
| Not at risk: Week 45 | 0 |
| Not at risk: Week 46 | 0 |
| Not at risk: Week 47 | 0 |
| Not at risk: Week 48 | 1 |
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| At risk: Week 37 | 0 |
| At risk: Week 38 | 13 |
| At risk: Week 39 | 40 |
| At risk: Week 40 | 68 |
| At risk: Week 41 | 86 |
| At risk: Week 42 | 103 |
| At risk: Week 43 | 109 |
| At risk: Week 44 | 113 |
| At risk: Week 45 | 118 |
| At risk: Week 46 | 121 |
| At risk: Week 47 | 121 |
| At risk: Week 48 | 121 |
| Not at risk: Week 37 | 0 |
| Not at risk: Week 38 | 2 |
| Not at risk: Week 39 | 4 |
| Not at risk: Week 40 | 5 |
| Not at risk: Week 41 | 8 |
| Not at risk: Week 42 | 9 |
| Not at risk: Week 43 | 9 |
| Not at risk: Week 44 | 9 |
| Not at risk: Week 45 | 9 |
| Not at risk: Week 46 | 9 |
| Not at risk: Week 47 | 9 |
| Not at risk: Week 48 | 10 |
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| At risk: Week 37 | 0 |
| At risk: Week 38 | 0 |
| At risk: Week 39 | 0 |
| At risk: Week 40 | 3 |
| At risk: Week 41 | 0 |
| At risk: Week 42 | 1 |
| At risk: Week 43 | 0 |
| At risk: Week 44 | 1 |
| At risk: Week 45 | 1 |
| At risk: Week 46 | 0 |
| At risk: Week 47 | 0 |
| At risk: Week 48 | 0 |
| Not at risk: Week 37 | 0 |
| Not at risk: Week 38 | 0 |
| Not at risk: Week 39 | 0 |
| Not at risk: Week 40 | 0 |
| Not at risk: Week 41 | 0 |
| Not at risk: Week 42 | 1 |
| Not at risk: Week 43 | 0 |
| Not at risk: Week 44 | 0 |
| Not at risk: Week 45 | 0 |
| Not at risk: Week 46 | 0 |
| Not at risk: Week 47 | 0 |
| Not at risk: Week 48 | 0 |
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| At risk: Week 37 | 0 |
| At risk: Week 38 | 0 |
| At risk: Week 39 | 0 |
| At risk: Week 40 | 3 |
| At risk: Week 41 | 3 |
| At risk: Week 42 | 4 |
| At risk: Week 43 | 4 |
| At risk: Week 44 | 5 |
| At risk: Week 45 | 6 |
| At risk: Week 46 | 6 |
| At risk: Week 47 | 6 |
| At risk: Week 48 | 6 |
| Not at risk: Week 37 | 0 |
| Not at risk: Week 38 | 0 |
| Not at risk: Week 39 | 0 |
| Not at risk: Week 40 | 0 |
| Not at risk: Week 41 | 0 |
| Not at risk: Week 42 | 1 |
| Not at risk: Week 43 | 1 |
| Not at risk: Week 44 | 1 |
| Not at risk: Week 45 | 1 |
| Not at risk: Week 46 | 1 |
| Not at risk: Week 47 | 1 |
| Not at risk: Week 48 | 1 |
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| At risk: Week 37 | 0 |
| At risk: Week 38 | 1 |
| At risk: Week 39 | 0 |
| At risk: Week 40 | 5 |
| At risk: Week 41 | 1 |
| At risk: Week 42 | 2 |
| At risk: Week 43 | 3 |
| At risk: Week 44 | 1 |
| At risk: Week 45 | 1 |
| At risk: Week 46 | 2 |
| At risk: Week 47 | 0 |
| At risk: Week 48 | 0 |
| Not at risk: Week 37 | 0 |
| Not at risk: Week 38 | 0 |
| Not at risk: Week 39 | 0 |
| Not at risk: Week 40 | 0 |
| Not at risk: Week 41 | 0 |
| Not at risk: Week 42 | 1 |
| Not at risk: Week 43 | 0 |
| Not at risk: Week 44 | 0 |
| Not at risk: Week 45 | 0 |
| Not at risk: Week 46 | 0 |
| Not at risk: Week 47 | 0 |
| Not at risk: Week 48 | 0 |
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| At risk: Week 37 | 0 |
| At risk: Week 38 | 1 |
| At risk: Week 39 | 1 |
| At risk: Week 40 | 6 |
| At risk: Week 41 | 7 |
| At risk: Week 42 | 9 |
| At risk: Week 43 | 12 |
| At risk: Week 44 | 13 |
| At risk: Week 45 | 14 |
| At risk: Week 46 | 16 |
| At risk: Week 47 | 16 |
| At risk: Week 48 | 16 |
| Not at risk: Week 37 | 0 |
| Not at risk: Week 38 | 0 |
| Not at risk: Week 39 | 0 |
| Not at risk: Week 40 | 0 |
| Not at risk: Week 41 | 0 |
| Not at risk: Week 42 | 1 |
| Not at risk: Week 43 | 1 |
| Not at risk: Week 44 | 1 |
| Not at risk: Week 45 | 1 |
| Not at risk: Week 46 | 1 |
| Not at risk: Week 47 | 1 |
| Not at risk: Week 48 | 1 |
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| At risk: Week 37 | 0 |
| At risk: Week 38 | 24 |
| At risk: Week 39 | 54 |
| At risk: Week 40 | 61 |
| At risk: Week 41 | 29 |
| At risk: Week 42 | 31 |
| At risk: Week 43 | 7 |
| At risk: Week 44 | 9 |
| At risk: Week 45 | 11 |
| At risk: Week 46 | 5 |
| At risk: Week 47 | 1 |
| At risk: Week 48 | 1 |
| Not at risk: Week 37 | 0 |
| Not at risk: Week 38 | 3 |
| Not at risk: Week 39 | 6 |
| Not at risk: Week 40 | 3 |
| Not at risk: Week 41 | 3 |
| Not at risk: Week 42 | 2 |
| Not at risk: Week 43 | 0 |
| Not at risk: Week 44 | 0 |
| Not at risk: Week 45 | 2 |
| Not at risk: Week 46 | 2 |
| Not at risk: Week 47 | 1 |
| Not at risk: Week 48 | 0 |
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| At risk: Week 37 | 0 |
| At risk: Week 38 | 24 |
| At risk: Week 39 | 78 |
| At risk: Week 40 | 139 |
| At risk: Week 41 | 168 |
| At risk: Week 42 | 199 |
| At risk: Week 43 | 206 |
| At risk: Week 44 | 215 |
| At risk: Week 45 | 226 |
| At risk: Week 46 | 231 |
| At risk: Week 47 | 232 |
| At risk: Week 48 | 233 |
| Not at risk: Week 37 | 0 |
| Not at risk: Week 38 | 3 |
| Not at risk: Week 39 | 9 |
| Not at risk: Week 40 | 12 |
| Not at risk: Week 41 | 15 |
| Not at risk: Week 42 | 17 |
| Not at risk: Week 43 | 17 |
| Not at risk: Week 44 | 17 |
| Not at risk: Week 45 | 19 |
| Not at risk: Week 46 | 21 |
| Not at risk: Week 47 | 22 |
| Not at risk: Week 48 | 22 |
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| At risk: Week 37 | 0 |
| At risk: Week 38 | 17 |
| At risk: Week 39 | 44 |
| At risk: Week 40 | 37 |
| At risk: Week 41 | 24 |
| At risk: Week 42 | 13 |
| At risk: Week 43 | 10 |
| At risk: Week 44 | 5 |
| At risk: Week 45 | 8 |
| At risk: Week 46 | 3 |
| At risk: Week 47 | 0 |
| At risk: Week 48 | 0 |
| Not at risk: Week 37 | 0 |
| Not at risk: Week 38 | 2 |
| Not at risk: Week 39 | 4 |
| Not at risk: Week 40 | 5 |
| Not at risk: Week 41 | 1 |
| Not at risk: Week 42 | 2 |
| Not at risk: Week 43 | 0 |
| Not at risk: Week 44 | 0 |
| Not at risk: Week 45 | 2 |
| Not at risk: Week 46 | 0 |
| Not at risk: Week 47 | 0 |
| Not at risk: Week 48 | 1 |
The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.
| Participants | Vaccinated_Fluarix Tetra Group |
|---|---|
| At risk: Week 37 | 0 |
| At risk: Week 38 | 17 |
| At risk: Week 39 | 61 |
| At risk: Week 40 | 98 |
| At risk: Week 41 | 122 |
| At risk: Week 42 | 135 |
| At risk: Week 43 | 145 |
| At risk: Week 44 | 150 |
| At risk: Week 45 | 158 |
| At risk: Week 46 | 161 |
| At risk: Week 47 | 161 |
| At risk: Week 48 | 161 |
| Not at risk: Week 37 | 0 |
| Not at risk: Week 38 | 2 |
| Not at risk: Week 39 | 6 |
| Not at risk: Week 40 | 11 |
| Not at risk: Week 41 | 12 |
| Not at risk: Week 42 | 14 |
| Not at risk: Week 43 | 14 |
| Not at risk: Week 44 | 14 |
| Not at risk: Week 45 | 16 |
| Not at risk: Week 46 | 16 |
| Not at risk: Week 47 | 16 |
| Not at risk: Week 48 | 17 |
AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| Week 37 | 0 | 0 | 0 |
| Week 38 | 87 | 4 | 7 |
| Week 39 | 227 | 10 | 3 |
| Week 40 | 218 | 11 | 4 |
| Week 41 | 172 | 5 | 7 |
| Week 42 | 118 | 10 | 8 |
| Week 43 | 57 | 4 | 10 |
| Week 44 | 52 | 6 | 4 |
| Week 45 | 54 | 2 | 4 |
| Week 46 | 37 | 6 | 2 |
| Week 47 | 14 | 2 | 3 |
| Week 48 | 13 | 2 | 2 |
AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| Week 37 | 0 | 0 | 0 |
| Week 38 | 87 | 4 | 7 |
| Week 39 | 314 | 14 | 10 |
| Week 40 | 532 | 25 | 14 |
| Week 41 | 704 | 30 | 21 |
| Week 42 | 822 | 40 | 29 |
| Week 43 | 879 | 44 | 39 |
| Week 44 | 931 | 50 | 43 |
| Week 45 | 985 | 52 | 47 |
| Week 46 | 1022 | 58 | 49 |
| Week 47 | 1036 | 60 | 52 |
| Week 48 | 1049 | 62 | 54 |
AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| Week 37 | 0 | 0 | 0 |
| Week 38 | 8 | 2 | 2 |
| Week 39 | 23 | 5 | 0 |
| Week 40 | 22 | 5 | 0 |
| Week 41 | 20 | 3 | 1 |
| Week 42 | 15 | 4 | 2 |
| Week 43 | 13 | 0 | 3 |
| Week 44 | 6 | 2 | 3 |
| Week 45 | 8 | 2 | 2 |
| Week 46 | 11 | 1 | 0 |
| Week 47 | 2 | 0 | 1 |
| Week 48 | 5 | 1 | 2 |
AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| Week 37 | 0 | 0 | 0 |
| Week 38 | 8 | 2 | 2 |
| Week 39 | 31 | 7 | 2 |
| Week 40 | 53 | 12 | 2 |
| Week 41 | 73 | 15 | 3 |
| Week 42 | 88 | 19 | 5 |
| Week 43 | 101 | 19 | 8 |
| Week 44 | 107 | 21 | 11 |
| Week 45 | 115 | 23 | 13 |
| Week 46 | 126 | 24 | 13 |
| Week 47 | 128 | 24 | 14 |
| Week 48 | 133 | 25 | 16 |
AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| Week 37 | 0 | 0 | 0 |
| Week 38 | 16 | 0 | 0 |
| Week 39 | 20 | 0 | 0 |
| Week 40 | 24 | 0 | 0 |
| Week 41 | 28 | 0 | 0 |
| Week 42 | 15 | 0 | 0 |
| Week 43 | 6 | 0 | 0 |
| Week 44 | 7 | 0 | 0 |
| Week 45 | 8 | 0 | 0 |
| Week 46 | 3 | 0 | 0 |
| Week 47 | 0 | 0 | 0 |
| Week 48 | 0 | 0 | 0 |
AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| Week 37 | 0 | 0 | 0 |
| Week 38 | 16 | 0 | 0 |
| Week 39 | 36 | 0 | 0 |
| Week 40 | 60 | 0 | 0 |
| Week 41 | 88 | 0 | 0 |
| Week 42 | 103 | 0 | 0 |
| Week 43 | 109 | 0 | 0 |
| Week 44 | 116 | 0 | 0 |
| Week 45 | 124 | 0 | 0 |
| Week 46 | 127 | 0 | 0 |
| Week 47 | 127 | 0 | 0 |
| Week 48 | 127 | 0 | 0 |
AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| Any, Week 37 | 0 | 0 | 0 |
| Any, Week 38 | 21 | 0 | 0 |
| Any, Week 39 | 51 | 1 | 0 |
| Any, Week 40 | 48 | 0 | 0 |
| Any, Week 41 | 28 | 0 | 0 |
| Any, Week 42 | 22 | 0 | 1 |
| Any, Week 43 | 5 | 0 | 0 |
| Any, Week 44 | 7 | 0 | 0 |
| Any, Week 45 | 10 | 0 | 0 |
| Any, Week 46 | 7 | 0 | 0 |
| Any, Week 47 | 2 | 0 | 0 |
| Any, Week 48 | 1 | 0 | 0 |
| Drowsiness, Week 37 | 0 | 0 | 0 |
| Drowsiness, Week 38 | 8 | 0 | 0 |
| Drowsiness, Week 39 | 20 | 0 | 0 |
| Drowsiness, Week 40 | 18 | 0 | 0 |
| Drowsiness, Week 41 | 10 | 0 | 0 |
| Drowsiness, Week 42 | 9 | 0 | 0 |
| Drowsiness, Week 43 | 1 | 0 | 0 |
| Drowsiness, Week 44 | 1 | 0 | 0 |
| Drowsiness, Week 45 | 2 | 0 | 0 |
| Drowsiness, Week 46 | 2 | 0 | 0 |
| Drowsiness, Week 47 | 1 | 0 | 0 |
| Drowsiness, Week 48 | 0 | 0 | 0 |
| Fatigue, Week 37 | 0 | 0 | 0 |
| Fatigue, Week 38 | 20 | 0 | 0 |
| Fatigue, Week 39 | 44 | 0 | 0 |
| Fatigue, Week 40 | 39 | 0 | 0 |
| Fatigue, Week 41 | 22 | 0 | 0 |
| Fatigue, Week 42 | 15 | 0 | 1 |
| Fatigue, Week 43 | 5 | 0 | 0 |
| Fatigue, Week 44 | 6 | 0 | 0 |
| Fatigue, Week 45 | 9 | 0 | 0 |
| Fatigue, Week 46 | 7 | 0 | 0 |
| Fatigue, Week 47 | 1 | 0 | 0 |
| Fatigue, Week 48 | 1 | 0 | 0 |
| Irritability, Week 37 | 0 | 0 | 0 |
| Irritability, Week 38 | 3 | 0 | 0 |
| Irritability, Week 39 | 2 | 0 | 0 |
| Irritability, Week 40 | 7 | 0 | 0 |
| Irritability, Week 41 | 1 | 0 | 0 |
| Irritability, Week 42 | 1 | 0 | 0 |
| Irritability, Week 43 | 1 | 0 | 0 |
| Irritability, Week 44 | 1 | 0 | 0 |
| Irritability, Week 45 | 1 | 0 | 0 |
| Irritability, Week 46 | 0 | 0 | 0 |
| Irritability, Week 47 | 0 | 0 | 0 |
| Irritability, Week 48 | 0 | 0 | 0 |
| Malaise, Week 37 | 0 | 0 | 0 |
| Malaise, Week 38 | 1 | 0 | 0 |
| Malaise, Week 39 | 0 | 1 | 0 |
| Malaise, Week 40 | 0 | 0 | 0 |
| Malaise, Week 41 | 1 | 0 | 0 |
| Malaise, Week 42 | 0 | 0 | 0 |
| Malaise, Week 43 | 0 | 0 | 0 |
| Malaise, Week 44 | 1 | 0 | 0 |
| Malaise, Week 45 | 1 | 0 | 0 |
| Malaise, Week 46 | 0 | 0 | 0 |
| Malaise, Week 47 | 0 | 0 | 0 |
| Malaise, Week 48 | 0 | 0 | 0 |
AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| Any, Week 37 | 0 | 0 | 0 |
| Any, Week 38 | 21 | 0 | 0 |
| Any, Week 39 | 72 | 1 | 0 |
| Any, Week 40 | 120 | 1 | 0 |
| Any, Week 41 | 148 | 1 | 0 |
| Any, Week 42 | 170 | 1 | 1 |
| Any, Week 43 | 175 | 1 | 1 |
| Any, Week 44 | 182 | 1 | 1 |
| Any, Week 45 | 192 | 1 | 1 |
| Any, Week 46 | 199 | 1 | 1 |
| Any, Week 47 | 201 | 1 | 1 |
| Any, Week 48 | 202 | 1 | 1 |
| Drowsiness, Week 37 | 0 | 0 | 0 |
| Drowsiness, Week 38 | 8 | 0 | 0 |
| Drowsiness, Week 39 | 28 | 0 | 0 |
| Drowsiness, Week 40 | 46 | 0 | 0 |
| Drowsiness, Week 41 | 56 | 0 | 0 |
| Drowsiness, Week 42 | 65 | 0 | 0 |
| Drowsiness, Week 43 | 66 | 0 | 0 |
| Drowsiness, Week 44 | 67 | 0 | 0 |
| Drowsiness, Week 45 | 69 | 0 | 0 |
| Drowsiness, Week 46 | 71 | 0 | 0 |
| Drowsiness, Week 47 | 72 | 0 | 0 |
| Drowsiness, Week 48 | 72 | 0 | 0 |
| Fatigue, Week 37 | 0 | 0 | 0 |
| Fatigue, Week 38 | 20 | 0 | 0 |
| Fatigue, Week 39 | 64 | 0 | 0 |
| Fatigue, Week 40 | 103 | 0 | 0 |
| Fatigue, Week 41 | 125 | 0 | 0 |
| Fatigue, Week 42 | 140 | 0 | 1 |
| Fatigue, Week 43 | 145 | 0 | 1 |
| Fatigue, Week 44 | 151 | 0 | 1 |
| Fatigue, Week 45 | 160 | 0 | 1 |
| Fatigue, Week 46 | 167 | 0 | 1 |
| Fatigue, Week 47 | 168 | 0 | 1 |
| Fatigue, Week 48 | 169 | 0 | 1 |
| Irritability, Week 37 | 0 | 0 | 0 |
| Irritability, Week 38 | 3 | 0 | 0 |
| Irritability, Week 39 | 5 | 0 | 0 |
| Irritability, Week 40 | 12 | 0 | 0 |
| Irritability, Week 41 | 13 | 0 | 0 |
| Irritability, Week 42 | 14 | 0 | 0 |
| Irritability, Week 43 | 15 | 0 | 0 |
| Irritability, Week 44 | 16 | 0 | 0 |
| Irritability, Week 45 | 17 | 0 | 0 |
| Irritability, Week 46 | 17 | 0 | 0 |
| Irritability, Week 47 | 17 | 0 | 0 |
| Irritability, Week 48 | 17 | 0 | 0 |
| Malaise, Week 37 | 0 | 0 | 0 |
| Malaise, Week 38 | 1 | 0 | 0 |
| Malaise, Week 39 | 1 | 1 | 0 |
| Malaise, Week 40 | 1 | 1 | 0 |
| Malaise, Week 41 | 2 | 1 | 0 |
| Malaise, Week 42 | 2 | 1 | 0 |
| Malaise, Week 43 | 2 | 1 | 0 |
| Malaise, Week 44 | 3 | 1 | 0 |
| Malaise, Week 45 | 4 | 1 | 0 |
| Malaise, Week 46 | 4 | 1 | 0 |
| Malaise, Week 47 | 4 | 1 | 0 |
| Malaise, Week 48 | 4 | 1 | 0 |
Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| Any, Week 37 | 0 | 0 | 0 |
| Any, Week 38 | 34 | 1 | 1 |
| Any, Week 39 | 120 | 3 | 0 |
| Any, Week 40 | 111 | 2 | 1 |
| Any, Week 41 | 82 | 2 | 2 |
| Any, Week 42 | 65 | 4 | 3 |
| Any, Week 43 | 29 | 1 | 5 |
| Any, Week 44 | 20 | 4 | 1 |
| Any, Week 45 | 29 | 0 | 0 |
| Any, Week 46 | 14 | 3 | 0 |
| Any, Week 47 | 7 | 2 | 0 |
| Any, Week 48 | 2 | 1 | 0 |
| Conjunctivitis, Week 37 | 0 | 0 | 0 |
| Conjunctivitis, Week 38 | 4 | 0 | 0 |
| Conjunctivitis, Week 39 | 10 | 0 | 0 |
| Conjunctivitis, Week 40 | 2 | 1 | 0 |
| Conjunctivitis, Week 41 | 5 | 0 | 0 |
| Conjunctivitis, Week 42 | 2 | 0 | 0 |
| Conjunctivitis, Week 43 | 1 | 0 | 0 |
| Conjunctivitis, Week 44 | 3 | 0 | 0 |
| Conjunctivitis, Week 45 | 1 | 0 | 0 |
| Conjunctivitis, Week 46 | 0 | 0 | 0 |
| Conjunctivitis, Week 47 | 0 | 0 | 0 |
| Conjunctivitis, Week 48 | 0 | 1 | 0 |
| Coryza, Week 37 | 0 | 0 | 0 |
| Coryza, Week 38 | 3 | 0 | 0 |
| Coryza, Week 39 | 19 | 0 | 0 |
| Coryza, Week 40 | 26 | 0 | 0 |
| Coryza, Week 41 | 11 | 0 | 0 |
| Coryza, Week 42 | 20 | 0 | 0 |
| Coryza, Week 43 | 4 | 0 | 0 |
| Coryza, Week 44 | 3 | 0 | 0 |
| Coryza, Week 45 | 7 | 0 | 0 |
| Coryza, Week 46 | 2 | 0 | 0 |
| Coryza, Week 47 | 0 | 0 | 0 |
| Coryza, Week 48 | 1 | 0 | 0 |
| Cough, Week 37 | 0 | 0 | 0 |
| Cough, Week 38 | 11 | 1 | 1 |
| Cough, Week 39 | 43 | 2 | 0 |
| Cough, Week 40 | 45 | 0 | 1 |
| Cough, Week 41 | 33 | 2 | 2 |
| Cough, Week 42 | 30 | 2 | 3 |
| Cough, Week 43 | 8 | 1 | 5 |
| Cough, Week 44 | 12 | 4 | 1 |
| Cough, Week 45 | 14 | 0 | 0 |
| Cough, Week 46 | 10 | 3 | 0 |
| Cough, Week 47 | 3 | 2 | 0 |
| Cough, Week 48 | 1 | 0 | 0 |
| Epistaxis, Week 37 | 0 | 0 | 0 |
| Epistaxis, Week 38 | 0 | 0 | 0 |
| Epistaxis, Week 39 | 2 | 1 | 0 |
| Epistaxis, Week 40 | 2 | 0 | 0 |
| Epistaxis, Week 41 | 4 | 0 | 0 |
| Epistaxis, Week 42 | 2 | 0 | 0 |
| Epistaxis, Week 43 | 0 | 0 | 0 |
| Epistaxis, Week 44 | 0 | 0 | 0 |
| Epistaxis, Week 45 | 2 | 0 | 0 |
| Epistaxis, Week 46 | 0 | 0 | 0 |
| Epistaxis, Week 47 | 0 | 0 | 0 |
| Epistaxis, Week 48 | 0 | 0 | 0 |
| Hoarseness, Week 37 | 0 | 0 | 0 |
| Hoarseness, Week 38 | 6 | 0 | 0 |
| Hoarseness, Week 39 | 15 | 0 | 0 |
| Hoarseness, Week 40 | 16 | 0 | 0 |
| Hoarseness, Week 41 | 15 | 0 | 0 |
| Hoarseness, Week 42 | 8 | 0 | 0 |
| Hoarseness, Week 43 | 3 | 0 | 0 |
| Hoarseness, Week 44 | 2 | 0 | 0 |
| Hoarseness, Week 45 | 3 | 0 | 0 |
| Hoarseness, Week 46 | 3 | 0 | 0 |
| Hoarseness, Week 47 | 0 | 0 | 0 |
| Hoarseness, Week 48 | 0 | 0 | 0 |
| Nasal congestion, Week 37 | 0 | 0 | 0 |
| Nasal congestion, Week 38 | 22 | 0 | 0 |
| Nasal congestion, Week 39 | 70 | 0 | 0 |
| Nasal congestion, Week 40 | 57 | 1 | 0 |
| Nasal congestion, Week 41 | 46 | 0 | 0 |
| Nasal congestion, Week 42 | 33 | 2 | 0 |
| Nasal congestion, Week 43 | 19 | 0 | 0 |
| Nasal congestion, Week 44 | 7 | 0 | 0 |
| Nasal congestion, Week 45 | 15 | 0 | 0 |
| Nasal congestion, Week 46 | 5 | 0 | 0 |
| Nasal congestion, Week 47 | 2 | 0 | 0 |
| Nasal congestion, Week 48 | 0 | 0 | 0 |
| Oropharyngeal pain, Week 37 | 0 | 0 | 0 |
| Oropharyngeal pain, Week 38 | 9 | 0 | 0 |
| Oropharyngeal pain, Week 39 | 33 | 0 | 0 |
| Oropharyngeal pain, Week 40 | 39 | 0 | 0 |
| Oropharyngeal pain, Week 41 | 21 | 0 | 0 |
| Oropharyngeal pain, Week 42 | 25 | 2 | 0 |
| Oropharyngeal pain, Week 43 | 10 | 0 | 0 |
| Oropharyngeal pain, Week 44 | 5 | 0 | 0 |
| Oropharyngeal pain, Week 45 | 8 | 0 | 0 |
| Oropharyngeal pain, Week 46 | 2 | 0 | 0 |
| Oropharyngeal pain, Week 47 | 3 | 0 | 0 |
| Oropharyngeal pain, Week 48 | 0 | 0 | 0 |
| Rhinorrhoea, Week 37 | 0 | 0 | 0 |
| Rhinorrhoea, Week 38 | 17 | 0 | 0 |
| Rhinorrhoea, Week 39 | 58 | 0 | 0 |
| Rhinorrhoea, Week 40 | 54 | 0 | 0 |
| Rhinorrhoea, Week 41 | 45 | 0 | 0 |
| Rhinorrhoea, Week 42 | 27 | 2 | 0 |
| Rhinorrhoea, Week 43 | 17 | 0 | 0 |
| Rhinorrhoea, Week 44 | 5 | 0 | 0 |
| Rhinorrhoea, Week 45 | 15 | 0 | 0 |
| Rhinorrhoea, Week 46 | 4 | 0 | 0 |
| Rhinorrhoea, Week 47 | 1 | 0 | 0 |
| Rhinorrhoea, Week 48 | 0 | 0 | 0 |
| Wheezing, Week 37 | 0 | 0 | 0 |
| Wheezing, Week 38 | 2 | 0 | 0 |
| Wheezing, Week 39 | 11 | 0 | 0 |
| Wheezing, Week 40 | 13 | 0 | 1 |
| Wheezing, Week 41 | 10 | 0 | 0 |
| Wheezing, Week 42 | 12 | 0 | 0 |
| Wheezing, Week 43 | 2 | 0 | 0 |
| Wheezing, Week 44 | 6 | 0 | 0 |
| Wheezing, Week 45 | 3 | 0 | 0 |
| Wheezing, Week 46 | 4 | 0 | 0 |
| Wheezing, Week 47 | 0 | 0 | 0 |
| Wheezing, Week 48 | 0 | 0 | 0 |
Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| Any, Week 37 | 0 | 0 | 0 |
| Any, Week 38 | 34 | 1 | 1 |
| Any, Week 39 | 154 | 4 | 1 |
| Any, Week 40 | 265 | 6 | 2 |
| Any, Week 41 | 347 | 8 | 4 |
| Any, Week 42 | 412 | 12 | 7 |
| Any, Week 43 | 441 | 13 | 12 |
| Any, Week 44 | 461 | 17 | 13 |
| Any, Week 45 | 490 | 17 | 13 |
| Any, Week 46 | 504 | 20 | 13 |
| Any, Week 47 | 511 | 22 | 13 |
| Any, Week 48 | 513 | 23 | 13 |
| Conjunctivitis, Week 37 | 0 | 0 | 0 |
| Conjunctivitis, Week 38 | 4 | 0 | 0 |
| Conjunctivitis, Week 39 | 14 | 0 | 0 |
| Conjunctivitis, Week 40 | 16 | 1 | 0 |
| Conjunctivitis, Week 41 | 21 | 1 | 0 |
| Conjunctivitis, Week 42 | 23 | 1 | 0 |
| Conjunctivitis, Week 43 | 24 | 1 | 0 |
| Conjunctivitis, Week 44 | 27 | 1 | 0 |
| Conjunctivitis, Week 45 | 28 | 1 | 0 |
| Conjunctivitis, Week 46 | 28 | 1 | 0 |
| Conjunctivitis, Week 47 | 28 | 1 | 0 |
| Conjunctivitis, Week 48 | 28 | 2 | 0 |
| Coryza, Week 37 | 0 | 0 | 0 |
| Coryza, Week 38 | 3 | 0 | 0 |
| Coryza, Week 39 | 22 | 0 | 0 |
| Coryza, Week 40 | 48 | 0 | 0 |
| Coryza, Week 41 | 59 | 0 | 0 |
| Coryza, Week 42 | 79 | 0 | 0 |
| Coryza, Week 43 | 83 | 0 | 0 |
| Coryza, Week 44 | 86 | 0 | 0 |
| Coryza, Week 45 | 93 | 0 | 0 |
| Coryza, Week 46 | 95 | 0 | 0 |
| Coryza, Week 47 | 95 | 0 | 0 |
| Coryza, Week 48 | 96 | 0 | 0 |
| Cough, Week 37 | 0 | 0 | 0 |
| Cough, Week 38 | 11 | 1 | 1 |
| Cough, Week 39 | 54 | 3 | 1 |
| Cough, Week 40 | 99 | 3 | 2 |
| Cough, Week 41 | 132 | 5 | 4 |
| Cough, Week 42 | 162 | 7 | 7 |
| Cough, Week 43 | 170 | 8 | 12 |
| Cough, Week 44 | 182 | 12 | 13 |
| Cough, Week 45 | 196 | 12 | 13 |
| Cough, Week 46 | 206 | 15 | 13 |
| Cough, Week 47 | 209 | 17 | 13 |
| Cough, Week 48 | 210 | 17 | 13 |
| Epistaxis, Week 37 | 0 | 0 | 0 |
| Epistaxis, Week 38 | 0 | 0 | 0 |
| Epistaxis, Week 39 | 2 | 1 | 0 |
| Epistaxis, Week 40 | 4 | 1 | 0 |
| Epistaxis, Week 41 | 8 | 1 | 0 |
| Epistaxis, Week 42 | 10 | 1 | 0 |
| Epistaxis, Week 43 | 10 | 1 | 0 |
| Epistaxis, Week 44 | 10 | 1 | 0 |
| Epistaxis, Week 45 | 12 | 1 | 0 |
| Epistaxis, Week 46 | 12 | 1 | 0 |
| Epistaxis, Week 47 | 12 | 1 | 0 |
| Epistaxis, Week 48 | 12 | 1 | 0 |
| Hoarseness, Week 37 | 0 | 0 | 0 |
| Hoarseness, Week 38 | 6 | 0 | 0 |
| Hoarseness, Week 39 | 21 | 0 | 0 |
| Hoarseness, Week 40 | 37 | 0 | 0 |
| Hoarseness, Week 41 | 52 | 0 | 0 |
| Hoarseness, Week 42 | 60 | 0 | 0 |
| Hoarseness, Week 43 | 63 | 0 | 0 |
| Hoarseness, Week 44 | 65 | 0 | 0 |
| Hoarseness, Week 45 | 68 | 0 | 0 |
| Hoarseness, Week 46 | 71 | 0 | 0 |
| Hoarseness, Week 47 | 71 | 0 | 0 |
| Hoarseness, Week 48 | 71 | 0 | 0 |
| Nasal congestion, Week 37 | 0 | 0 | 0 |
| Nasal congestion, Week 38 | 22 | 0 | 0 |
| Nasal congestion, Week 39 | 92 | 0 | 0 |
| Nasal congestion, Week 40 | 149 | 1 | 0 |
| Nasal congestion, Week 41 | 195 | 1 | 0 |
| Nasal congestion, Week 42 | 228 | 3 | 0 |
| Nasal congestion, Week 43 | 247 | 3 | 0 |
| Nasal congestion, Week 44 | 254 | 3 | 0 |
| Nasal congestion, Week 45 | 269 | 3 | 0 |
| Nasal congestion, Week 46 | 274 | 3 | 0 |
| Nasal congestion, Week 47 | 276 | 3 | 0 |
| Nasal congestion, Week 48 | 276 | 3 | 0 |
| Oropharyngeal pain, Week 37 | 0 | 0 | 0 |
| Oropharyngeal pain, Week 38 | 9 | 0 | 0 |
| Oropharyngeal pain, Week 39 | 42 | 0 | 0 |
| Oropharyngeal pain, Week 40 | 81 | 0 | 0 |
| Oropharyngeal pain, Week 41 | 102 | 0 | 0 |
| Oropharyngeal pain, Week 42 | 127 | 2 | 0 |
| Oropharyngeal pain, Week 43 | 137 | 2 | 0 |
| Oropharyngeal pain, Week 44 | 142 | 2 | 0 |
| Oropharyngeal pain, Week 45 | 150 | 2 | 0 |
| Oropharyngeal pain, Week 46 | 152 | 2 | 0 |
| Oropharyngeal pain, Week 47 | 155 | 2 | 0 |
| Oropharyngeal pain, Week 48 | 155 | 2 | 0 |
| Rhinorrhoea, Week 37 | 0 | 0 | 0 |
| Rhinorrhoea, Week 38 | 17 | 0 | 0 |
| Rhinorrhoea, Week 39 | 75 | 0 | 0 |
| Rhinorrhoea, Week 40 | 129 | 0 | 0 |
| Rhinorrhoea, Week 41 | 174 | 0 | 0 |
| Rhinorrhoea, Week 42 | 201 | 2 | 0 |
| Rhinorrhoea, Week 43 | 218 | 2 | 0 |
| Rhinorrhoea, Week 44 | 223 | 2 | 0 |
| Rhinorrhoea, Week 45 | 238 | 2 | 0 |
| Rhinorrhoea, Week 46 | 242 | 2 | 0 |
| Rhinorrhoea, Week 47 | 243 | 2 | 0 |
| Rhinorrhoea, Week 48 | 243 | 2 | 0 |
| Wheezing, Week 37 | 0 | 0 | 0 |
| Wheezing, Week 38 | 2 | 0 | 0 |
| Wheezing, Week 39 | 13 | 0 | 0 |
| Wheezing, Week 40 | 26 | 0 | 1 |
| Wheezing, Week 41 | 36 | 0 | 1 |
| Wheezing, Week 42 | 48 | 0 | 1 |
| Wheezing, Week 43 | 50 | 0 | 1 |
| Wheezing, Week 44 | 56 | 0 | 1 |
| Wheezing, Week 45 | 59 | 0 | 1 |
| Wheezing, Week 46 | 63 | 0 | 1 |
| Wheezing, Week 47 | 63 | 0 | 1 |
| Wheezing, Week 48 | 63 | 0 | 1 |
Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| Any, Week 37 | 0 | 0 | 0 |
| Any, Week 38 | 18 | 0 | 0 |
| Any, Week 39 | 32 | 0 | 0 |
| Any, Week 40 | 34 | 0 | 1 |
| Any, Week 41 | 25 | 0 | 1 |
| Any, Week 42 | 19 | 2 | 0 |
| Any, Week 43 | 9 | 0 | 0 |
| Any, Week 44 | 5 | 0 | 0 |
| Any, Week 45 | 6 | 0 | 0 |
| Any, Week 46 | 4 | 0 | 1 |
| Any, Week 47 | 1 | 0 | 0 |
| Any, Week 48 | 1 | 0 | 0 |
| Decreased appetite, Week 37 | 0 | 0 | 0 |
| Decreased appetite, Week 38 | 7 | 0 | 0 |
| Decreased appetite, Week 39 | 11 | 0 | 0 |
| Decreased appetite, Week 40 | 12 | 0 | 1 |
| Decreased appetite, Week 41 | 7 | 0 | 0 |
| Decreased appetite, Week 42 | 6 | 1 | 0 |
| Decreased appetite, Week 43 | 2 | 0 | 0 |
| Decreased appetite, Week 44 | 1 | 0 | 0 |
| Decreased appetite, Week 45 | 2 | 0 | 0 |
| Decreased appetite, Week 46 | 2 | 0 | 0 |
| Decreased appetite, Week 47 | 0 | 0 | 0 |
| Decreased appetite, Week 48 | 0 | 0 | 0 |
| Diarrhoea, Week 37 | 0 | 0 | 0 |
| Diarrhoea, Week 38 | 6 | 0 | 0 |
| Diarrhoea, Week 39 | 12 | 0 | 0 |
| Diarrhoea, Week 40 | 14 | 0 | 0 |
| Diarrhoea, Week 41 | 12 | 0 | 1 |
| Diarrhoea, Week 42 | 6 | 0 | 0 |
| Diarrhoea, Week 43 | 5 | 0 | 0 |
| Diarrhoea, Week 44 | 4 | 0 | 0 |
| Diarrhoea, Week 45 | 3 | 0 | 0 |
| Diarrhoea, Week 46 | 1 | 0 | 1 |
| Diarrhoea, Week 47 | 1 | 0 | 0 |
| Diarrhoea, Week 48 | 0 | 0 | 0 |
| Nausea, Week 37 | 0 | 0 | 0 |
| Nausea, Week 38 | 12 | 0 | 0 |
| Nausea, Week 39 | 18 | 0 | 0 |
| Nausea, Week 40 | 15 | 0 | 0 |
| Nausea, Week 41 | 8 | 0 | 0 |
| Nausea, Week 42 | 9 | 0 | 0 |
| Nausea, Week 43 | 3 | 0 | 0 |
| Nausea, Week 44 | 0 | 0 | 0 |
| Nausea, Week 45 | 4 | 0 | 0 |
| Nausea, Week 46 | 1 | 0 | 0 |
| Nausea, Week 47 | 0 | 0 | 0 |
| Nausea, Week 48 | 1 | 0 | 0 |
| Vomiting, Week 37 | 0 | 0 | 0 |
| Vomiting, Week 38 | 3 | 0 | 0 |
| Vomiting, Week 39 | 2 | 0 | 0 |
| Vomiting, Week 40 | 7 | 0 | 0 |
| Vomiting, Week 41 | 1 | 0 | 0 |
| Vomiting, Week 42 | 3 | 1 | 0 |
| Vomiting, Week 43 | 1 | 0 | 0 |
| Vomiting, Week 44 | 0 | 0 | 0 |
| Vomiting, Week 45 | 2 | 0 | 0 |
| Vomiting, Week 46 | 0 | 0 | 0 |
| Vomiting, Week 47 | 0 | 0 | 0 |
| Vomiting, Week 48 | 0 | 0 | 0 |
Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| Any, Week 37 | 0 | 0 | 0 |
| Any, Week 38 | 18 | 0 | 0 |
| Any, Week 39 | 50 | 0 | 0 |
| Any, Week 40 | 84 | 0 | 1 |
| Any, Week 41 | 109 | 0 | 2 |
| Any, Week 42 | 128 | 2 | 2 |
| Any, Week 43 | 137 | 2 | 2 |
| Any, Week 44 | 142 | 2 | 2 |
| Any, Week 45 | 148 | 2 | 2 |
| Any, Week 46 | 152 | 2 | 3 |
| Any, Week 47 | 153 | 2 | 3 |
| Any, Week 48 | 154 | 2 | 3 |
| Decreased appetite, Week 37 | 0 | 0 | 0 |
| Decreased appetite, Week 38 | 7 | 0 | 0 |
| Decreased appetite, Week 39 | 18 | 0 | 0 |
| Decreased appetite, Week 40 | 30 | 0 | 1 |
| Decreased appetite, Week 41 | 37 | 0 | 1 |
| Decreased appetite, Week 42 | 43 | 1 | 1 |
| Decreased appetite, Week 43 | 45 | 1 | 1 |
| Decreased appetite, Week 44 | 46 | 1 | 1 |
| Decreased appetite, Week 45 | 48 | 1 | 1 |
| Decreased appetite, Week 46 | 50 | 1 | 1 |
| Decreased appetite, Week 47 | 50 | 1 | 1 |
| Decreased appetite, Week 48 | 50 | 1 | 1 |
| Diarrhoea, Week 37 | 0 | 0 | 0 |
| Diarrhoea, Week 38 | 6 | 0 | 0 |
| Diarrhoea, Week 39 | 18 | 0 | 0 |
| Diarrhoea, Week 40 | 32 | 0 | 0 |
| Diarrhoea, Week 41 | 44 | 0 | 1 |
| Diarrhoea, Week 42 | 50 | 0 | 1 |
| Diarrhoea, Week 43 | 55 | 0 | 1 |
| Diarrhoea, Week 44 | 59 | 0 | 1 |
| Diarrhoea, Week 45 | 62 | 0 | 1 |
| Diarrhoea, Week 46 | 63 | 0 | 2 |
| Diarrhoea, Week 47 | 64 | 0 | 2 |
| Diarrhoea, Week 48 | 64 | 0 | 2 |
| Nausea, Week 37 | 0 | 0 | 0 |
| Nausea, Week 38 | 12 | 0 | 0 |
| Nausea, Week 39 | 30 | 0 | 0 |
| Nausea, Week 40 | 45 | 0 | 0 |
| Nausea, Week 41 | 53 | 0 | 0 |
| Nausea, Week 42 | 62 | 0 | 0 |
| Nausea, Week 43 | 65 | 0 | 0 |
| Nausea, Week 44 | 65 | 0 | 0 |
| Nausea, Week 45 | 69 | 0 | 0 |
| Nausea, Week 46 | 70 | 0 | 0 |
| Nausea, Week 47 | 70 | 0 | 0 |
| Nausea, Week 48 | 71 | 0 | 0 |
| Vomiting, Week 37 | 0 | 0 | 0 |
| Vomiting, Week 38 | 3 | 0 | 0 |
| Vomiting, Week 39 | 5 | 0 | 0 |
| Vomiting, Week 40 | 12 | 0 | 0 |
| Vomiting, Week 41 | 13 | 0 | 0 |
| Vomiting, Week 42 | 16 | 1 | 0 |
| Vomiting, Week 43 | 17 | 1 | 0 |
| Vomiting, Week 44 | 17 | 1 | 0 |
| Vomiting, Week 45 | 19 | 1 | 0 |
| Vomiting, Week 46 | 19 | 1 | 0 |
| Vomiting, Week 47 | 19 | 1 | 0 |
| Vomiting, Week 48 | 19 | 1 | 0 |
Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| Any, Week 37 | 0 | 0 | 0 |
| Any, Week 38 | 1 | 1 | 0 |
| Any, Week 39 | 2 | 0 | 0 |
| Any, Week 40 | 3 | 0 | 0 |
| Any, Week 41 | 0 | 0 | 0 |
| Any, Week 42 | 3 | 0 | 0 |
| Any, Week 43 | 2 | 0 | 0 |
| Any, Week 44 | 1 | 0 | 0 |
| Any, Week 45 | 1 | 0 | 0 |
| Any, Week 46 | 1 | 0 | 0 |
| Any, Week 47 | 0 | 0 | 0 |
| Any, Week 48 | 1 | 0 | 0 |
| Anaphylactic reactions, Week 37 | 0 | 0 | 0 |
| Anaphylactic reactions, Week 38 | 0 | 0 | 0 |
| Anaphylactic reactions, Week 39 | 0 | 0 | 0 |
| Anaphylactic reactions, Week 40 | 0 | 0 | 0 |
| Anaphylactic reactions, Week 41 | 0 | 0 | 0 |
| Anaphylactic reactions, Week 42 | 0 | 0 | 0 |
| Anaphylactic reactions, Week 43 | 0 | 0 | 0 |
| Anaphylactic reactions, Week 44 | 0 | 0 | 0 |
| Anaphylactic reactions, Week 45 | 0 | 0 | 0 |
| Anaphylactic reactions, Week 46 | 0 | 0 | 0 |
| Anaphylactic reactions, Week 47 | 0 | 0 | 0 |
| Anaphylactic reactions, Week 48 | 0 | 0 | 0 |
| Facial oedema, Week 37 | 0 | 0 | 0 |
| Facial oedema, Week 38 | 0 | 0 | 0 |
| Facial oedema, Week 39 | 0 | 0 | 0 |
| Facial oedema, Week 40 | 1 | 0 | 0 |
| Facial oedema, Week 41 | 0 | 0 | 0 |
| Facial oedema, Week 42 | 0 | 0 | 0 |
| Facial oedema, Week 43 | 0 | 0 | 0 |
| Facial oedema, Week 44 | 0 | 0 | 0 |
| Facial oedema, Week 45 | 0 | 0 | 0 |
| Facial oedema, Week 46 | 0 | 0 | 0 |
| Facial oedema, Week 47 | 0 | 0 | 0 |
| Facial oedema, Week 48 | 0 | 0 | 0 |
| Hypersensitivity reactions, Week 37 | 0 | 0 | 0 |
| Hypersensitivity reactions, Week 38 | 1 | 1 | 0 |
| Hypersensitivity reactions, Week 39 | 2 | 0 | 0 |
| Hypersensitivity reactions, Week 40 | 2 | 0 | 0 |
| Hypersensitivity reactions, Week 41 | 0 | 0 | 0 |
| Hypersensitivity reactions, Week 42 | 3 | 0 | 0 |
| Hypersensitivity reactions, Week 43 | 2 | 0 | 0 |
| Hypersensitivity reactions, Week 44 | 1 | 0 | 0 |
| Hypersensitivity reactions, Week 45 | 1 | 0 | 0 |
| Hypersensitivity reactions, Week 46 | 1 | 0 | 0 |
| Hypersensitivity reactions, Week 47 | 0 | 0 | 0 |
| Hypersensitivity reactions, Week 48 | 1 | 0 | 0 |
Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| Any, Week 37 | 0 | 0 | 0 |
| Any, Week 38 | 1 | 1 | 0 |
| Any, Week 39 | 3 | 1 | 0 |
| Any, Week 40 | 6 | 1 | 0 |
| Any, Week 41 | 6 | 1 | 0 |
| Any, Week 42 | 9 | 1 | 0 |
| Any, Week 43 | 11 | 1 | 0 |
| Any, Week 44 | 12 | 1 | 0 |
| Any, Week 45 | 13 | 1 | 0 |
| Any, Week 46 | 14 | 1 | 0 |
| Any, Week 47 | 14 | 1 | 0 |
| Any, Week 48 | 15 | 1 | 0 |
| Anaphylactic reactions, Week 37 | 0 | 0 | 0 |
| Anaphylactic reactions, Week 38 | 0 | 0 | 0 |
| Anaphylactic reactions, Week 39 | 0 | 0 | 0 |
| Anaphylactic reactions, Week 40 | 0 | 0 | 0 |
| Anaphylactic reactions, Week 41 | 0 | 0 | 0 |
| Anaphylactic reactions, Week 42 | 0 | 0 | 0 |
| Anaphylactic reactions, Week 43 | 0 | 0 | 0 |
| Anaphylactic reactions, Week 44 | 0 | 0 | 0 |
| Anaphylactic reactions, Week 45 | 0 | 0 | 0 |
| Anaphylactic reactions, Week 46 | 0 | 0 | 0 |
| Anaphylactic reactions, Week 47 | 0 | 0 | 0 |
| Anaphylactic reactions, Week 48 | 0 | 0 | 0 |
| Facial oedema, Week 37 | 0 | 0 | 0 |
| Facial oedema, Week 38 | 0 | 0 | 0 |
| Facial oedema, Week 39 | 0 | 0 | 0 |
| Facial oedema, Week 40 | 1 | 0 | 0 |
| Facial oedema, Week 41 | 1 | 0 | 0 |
| Facial oedema, Week 42 | 1 | 0 | 0 |
| Facial oedema, Week 43 | 1 | 0 | 0 |
| Facial oedema, Week 44 | 1 | 0 | 0 |
| Facial oedema, Week 45 | 1 | 0 | 0 |
| Facial oedema, Week 46 | 1 | 0 | 0 |
| Facial oedema, Week 47 | 1 | 0 | 0 |
| Facial oedema, Week 48 | 1 | 0 | 0 |
| Hypersensitivity reactions, Week 37 | 0 | 0 | 0 |
| Hypersensitivity reactions, Week 38 | 1 | 1 | 0 |
| Hypersensitivity reactions, Week 39 | 3 | 1 | 0 |
| Hypersensitivity reactions, Week 40 | 5 | 1 | 0 |
| Hypersensitivity reactions, Week 41 | 5 | 1 | 0 |
| Hypersensitivity reactions, Week 42 | 8 | 1 | 0 |
| Hypersensitivity reactions, Week 43 | 10 | 1 | 0 |
| Hypersensitivity reactions, Week 44 | 11 | 1 | 0 |
| Hypersensitivity reactions, Week 45 | 12 | 1 | 0 |
| Hypersensitivity reactions, Week 46 | 13 | 1 | 0 |
| Hypersensitivity reactions, Week 47 | 13 | 1 | 0 |
| Hypersensitivity reactions, Week 48 | 14 | 1 | 0 |
Rash AEs include any rash AEs, generalised rash and rash.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| Any, Week 37 | 0 | 0 | 0 |
| Any, Week 38 | 2 | 0 | 0 |
| Any, Week 39 | 10 | 0 | 0 |
| Any, Week 40 | 7 | 3 | 0 |
| Any, Week 41 | 7 | 0 | 0 |
| Any, Week 42 | 5 | 2 | 0 |
| Any, Week 43 | 4 | 1 | 0 |
| Any, Week 44 | 3 | 0 | 0 |
| Any, Week 45 | 2 | 0 | 0 |
| Any, Week 46 | 4 | 0 | 1 |
| Any, Week 47 | 3 | 0 | 1 |
| Any, Week 48 | 0 | 0 | 0 |
| Generalised rash, Week 37 | 0 | 0 | 0 |
| Generalised rash, Week 38 | 1 | 0 | 0 |
| Generalised rash, Week 39 | 10 | 0 | 0 |
| Generalised rash, Week 40 | 3 | 3 | 0 |
| Generalised rash, Week 41 | 6 | 0 | 0 |
| Generalised rash, Week 42 | 2 | 2 | 0 |
| Generalised rash, Week 43 | 1 | 1 | 0 |
| Generalised rash, Week 44 | 2 | 0 | 0 |
| Generalised rash, Week 45 | 1 | 0 | 0 |
| Generalised rash, Week 46 | 2 | 0 | 1 |
| Generalised rash, Week 47 | 3 | 0 | 1 |
| Generalised rash, Week 48 | 0 | 0 | 0 |
| Rash, Week 37 | 0 | 0 | 0 |
| Rash, Week 38 | 1 | 0 | 0 |
| Rash, Week 39 | 0 | 0 | 0 |
| Rash, Week 40 | 4 | 0 | 0 |
| Rash, Week 41 | 1 | 0 | 0 |
| Rash, Week 42 | 3 | 0 | 0 |
| Rash, Week 43 | 3 | 0 | 0 |
| Rash, Week 44 | 1 | 0 | 0 |
| Rash, Week 45 | 1 | 0 | 0 |
| Rash, Week 46 | 2 | 0 | 0 |
| Rash, Week 47 | 0 | 0 | 0 |
| Rash, Week 48 | 0 | 0 | 0 |
Rash AEs include any rash AEs, generalised rash and rash.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| Any, Week 37 | 0 | 0 | 0 |
| Any, Week 38 | 2 | 0 | 0 |
| Any, Week 39 | 12 | 0 | 0 |
| Any, Week 40 | 19 | 3 | 0 |
| Any, Week 41 | 26 | 3 | 0 |
| Any, Week 42 | 31 | 5 | 0 |
| Any, Week 43 | 35 | 6 | 0 |
| Any, Week 44 | 38 | 6 | 0 |
| Any, Week 45 | 40 | 6 | 0 |
| Any, Week 46 | 44 | 6 | 1 |
| Any, Week 47 | 47 | 6 | 2 |
| Any, Week 48 | 47 | 6 | 2 |
| Generalised rash, Week 37 | 0 | 0 | 0 |
| Generalised rash, Week 38 | 1 | 0 | 0 |
| Generalised rash, Week 39 | 11 | 0 | 0 |
| Generalised rash, Week 40 | 14 | 3 | 0 |
| Generalised rash, Week 41 | 20 | 3 | 0 |
| Generalised rash, Week 42 | 22 | 5 | 0 |
| Generalised rash, Week 43 | 23 | 6 | 0 |
| Generalised rash, Week 44 | 25 | 6 | 0 |
| Generalised rash, Week 45 | 26 | 6 | 0 |
| Generalised rash, Week 46 | 28 | 6 | 1 |
| Generalised rash, Week 47 | 31 | 6 | 2 |
| Generalised rash, Week 48 | 31 | 6 | 2 |
| Rash, Week 37 | 0 | 0 | 0 |
| Rash, Week 38 | 1 | 0 | 0 |
| Rash, Week 39 | 1 | 0 | 0 |
| Rash, Week 40 | 5 | 0 | 0 |
| Rash, Week 41 | 6 | 0 | 0 |
| Rash, Week 42 | 9 | 0 | 0 |
| Rash, Week 43 | 12 | 0 | 0 |
| Rash, Week 44 | 13 | 0 | 0 |
| Rash, Week 45 | 14 | 0 | 0 |
| Rash, Week 46 | 16 | 0 | 0 |
| Rash, Week 47 | 16 | 0 | 0 |
| Rash, Week 48 | 16 | 0 | 0 |
Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| Any, Week 37 | 0 | 0 | 0 |
| Any, Week 38 | 32 | 1 | 4 |
| Any, Week 39 | 71 | 2 | 3 |
| Any, Week 40 | 75 | 1 | 3 |
| Any, Week 41 | 48 | 1 | 0 |
| Any, Week 42 | 46 | 0 | 2 |
| Any, Week 43 | 8 | 1 | 0 |
| Any, Week 44 | 15 | 0 | 0 |
| Any, Week 45 | 18 | 0 | 2 |
| Any, Week 46 | 12 | 1 | 0 |
| Any, Week 47 | 2 | 0 | 1 |
| Any, Week 48 | 4 | 0 | 0 |
| Arthropathy, Week 37 | 0 | 0 | 0 |
| Arthropathy, Week 38 | 8 | 0 | 0 |
| Arthropathy, Week 39 | 17 | 0 | 0 |
| Arthropathy, Week 40 | 24 | 0 | 0 |
| Arthropathy, Week 41 | 9 | 0 | 0 |
| Arthropathy, Week 42 | 11 | 0 | 0 |
| Arthropathy, Week 43 | 2 | 0 | 0 |
| Arthropathy, Week 44 | 2 | 0 | 0 |
| Arthropathy, Week 45 | 5 | 0 | 0 |
| Arthropathy, Week 46 | 1 | 0 | 0 |
| Arthropathy, Week 47 | 0 | 0 | 0 |
| Arthropathy, Week 48 | 0 | 0 | 0 |
| Muscle aches/myalgia, Week 37 | 0 | 0 | 0 |
| Muscle aches/myalgia, Week 38 | 30 | 1 | 4 |
| Muscle aches/myalgia, Week 39 | 69 | 2 | 3 |
| Muscle aches/myalgia, Week 40 | 68 | 1 | 3 |
| Muscle aches/myalgia, Week 41 | 46 | 1 | 0 |
| Muscle aches/myalgia, Week 42 | 42 | 0 | 2 |
| Muscle aches/myalgia, Week 43 | 8 | 1 | 0 |
| Muscle aches/myalgia, Week 44 | 13 | 0 | 0 |
| Muscle aches/myalgia, Week 45 | 18 | 0 | 2 |
| Muscle aches/myalgia, Week 46 | 11 | 1 | 0 |
| Muscle aches/myalgia, Week 47 | 2 | 0 | 1 |
| Muscle aches/myalgia, Week 48 | 4 | 0 | 0 |
Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| Any, Week 37 | 0 | 0 | 0 |
| Any, Week 38 | 32 | 1 | 4 |
| Any, Week 39 | 103 | 3 | 7 |
| Any, Week 40 | 178 | 4 | 10 |
| Any, Week 41 | 226 | 5 | 10 |
| Any, Week 42 | 272 | 5 | 12 |
| Any, Week 43 | 280 | 6 | 12 |
| Any, Week 44 | 295 | 6 | 12 |
| Any, Week 45 | 313 | 6 | 14 |
| Any, Week 46 | 325 | 7 | 14 |
| Any, Week 47 | 327 | 7 | 15 |
| Any, Week 48 | 331 | 7 | 15 |
| Arthropathy, Week 37 | 0 | 0 | 0 |
| Arthropathy, Week 38 | 8 | 0 | 0 |
| Arthropathy, Week 39 | 25 | 0 | 0 |
| Arthropathy, Week 40 | 49 | 0 | 0 |
| Arthropathy, Week 41 | 58 | 0 | 0 |
| Arthropathy, Week 42 | 69 | 0 | 0 |
| Arthropathy, Week 43 | 71 | 0 | 0 |
| Arthropathy, Week 44 | 73 | 0 | 0 |
| Arthropathy, Week 45 | 78 | 0 | 0 |
| Arthropathy, Week 46 | 79 | 0 | 0 |
| Arthropathy, Week 47 | 79 | 0 | 0 |
| Arthropathy, Week 48 | 79 | 0 | 0 |
| Muscle aches/myalgia, Week 37 | 0 | 0 | 0 |
| Muscle aches/myalgia, Week 38 | 30 | 1 | 4 |
| Muscle aches/myalgia, Week 39 | 99 | 3 | 7 |
| Muscle aches/myalgia, Week 40 | 167 | 4 | 10 |
| Muscle aches/myalgia, Week 41 | 213 | 5 | 10 |
| Muscle aches/myalgia, Week 42 | 255 | 5 | 12 |
| Muscle aches/myalgia, Week 43 | 263 | 6 | 12 |
| Muscle aches/myalgia, Week 44 | 276 | 6 | 12 |
| Muscle aches/myalgia, Week 45 | 294 | 6 | 14 |
| Muscle aches/myalgia, Week 46 | 305 | 7 | 14 |
| Muscle aches/myalgia, Week 47 | 307 | 7 | 15 |
| Muscle aches/myalgia, Week 48 | 311 | 7 | 15 |
Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| Any, Week 37 | 0 | 0 | 0 |
| Any, Week 38 | 22 | 0 | 0 |
| Any, Week 39 | 52 | 1 | 0 |
| Any, Week 40 | 46 | 1 | 0 |
| Any, Week 41 | 31 | 0 | 3 |
| Any, Week 42 | 17 | 1 | 0 |
| Any, Week 43 | 13 | 1 | 2 |
| Any, Week 44 | 7 | 1 | 0 |
| Any, Week 45 | 13 | 0 | 0 |
| Any, Week 46 | 3 | 1 | 0 |
| Any, Week 47 | 1 | 0 | 0 |
| Any, Week 48 | 1 | 0 | 0 |
| Bell's palsy, Week 37 | 0 | 0 | 0 |
| Bell's palsy, Week 38 | 0 | 0 | 0 |
| Bell's palsy, Week 39 | 0 | 0 | 0 |
| Bell's palsy, Week 40 | 0 | 0 | 0 |
| Bell's palsy, Week 41 | 0 | 0 | 0 |
| Bell's palsy, Week 42 | 0 | 0 | 0 |
| Bell's palsy, Week 43 | 0 | 0 | 0 |
| Bell's palsy, Week 44 | 0 | 0 | 0 |
| Bell's palsy, Week 45 | 0 | 0 | 0 |
| Bell's palsy, Week 46 | 0 | 0 | 0 |
| Bell's palsy, Week 47 | 0 | 0 | 0 |
| Bell's palsy, Week 48 | 0 | 0 | 0 |
| Guillain-Barre Syndrome, Week 37 | 0 | 0 | 0 |
| Guillain-Barre Syndrome, Week 38 | 0 | 0 | 0 |
| Guillain-Barre Syndrome, Week 39 | 0 | 0 | 0 |
| Guillain-Barre Syndrome, Week 40 | 0 | 0 | 0 |
| Guillain-Barre Syndrome, Week 41 | 0 | 0 | 0 |
| Guillain-Barre Syndrome, Week 42 | 0 | 0 | 0 |
| Guillain-Barre Syndrome, Week 43 | 0 | 0 | 0 |
| Guillain-Barre Syndrome, Week 44 | 0 | 0 | 0 |
| Guillain-Barre Syndrome, Week 45 | 0 | 0 | 0 |
| Guillain-Barre Syndrome, Week 46 | 0 | 0 | 0 |
| Guillain-Barre Syndrome, Week 47 | 0 | 0 | 0 |
| Guillain-Barre Syndrome, Week 48 | 0 | 0 | 0 |
| Headache, Week 37 | 0 | 0 | 0 |
| Headache, Week 38 | 20 | 0 | 0 |
| Headache, Week 39 | 52 | 1 | 0 |
| Headache, Week 40 | 44 | 1 | 0 |
| Headache, Week 41 | 28 | 0 | 3 |
| Headache, Week 42 | 15 | 1 | 0 |
| Headache, Week 43 | 11 | 1 | 2 |
| Headache, Week 44 | 6 | 1 | 0 |
| Headache, Week 45 | 11 | 0 | 0 |
| Headache, Week 46 | 3 | 1 | 0 |
| Headache, Week 47 | 1 | 0 | 0 |
| Headache, Week 48 | 1 | 0 | 0 |
| Peripheral tremor, Week 37 | 0 | 0 | 0 |
| Peripheral tremor, Week 38 | 3 | 0 | 0 |
| Peripheral tremor, Week 39 | 5 | 0 | 0 |
| Peripheral tremor, Week 40 | 1 | 0 | 0 |
| Peripheral tremor, Week 41 | 8 | 0 | 0 |
| Peripheral tremor, Week 42 | 3 | 0 | 0 |
| Peripheral tremor, Week 43 | 2 | 0 | 0 |
| Peripheral tremor, Week 44 | 1 | 0 | 0 |
| Peripheral tremor, Week 45 | 1 | 0 | 0 |
| Peripheral tremor, Week 46 | 0 | 0 | 0 |
| Peripheral tremor, Week 47 | 0 | 0 | 0 |
| Peripheral tremor, Week 48 | 0 | 0 | 0 |
| Seizure/Febrile convulsions, Week 37 | 0 | 0 | 0 |
| Seizure/Febrile convulsions, Week 38 | 0 | 0 | 0 |
| Seizure/Febrile convulsions, Week 39 | 0 | 0 | 0 |
| Seizure/Febrile convulsions, Week 40 | 1 | 0 | 0 |
| Seizure/Febrile convulsions, Week 41 | 0 | 0 | 0 |
| Seizure/Febrile convulsions, Week 42 | 0 | 0 | 0 |
| Seizure/Febrile convulsions, Week 43 | 0 | 0 | 0 |
| Seizure/Febrile convulsions, Week 44 | 0 | 0 | 0 |
| Seizure/Febrile convulsions, Week 45 | 1 | 0 | 0 |
| Seizure/Febrile convulsions, Week 46 | 0 | 0 | 0 |
| Seizure/Febrile convulsions, Week 47 | 0 | 0 | 0 |
| Seizure/Febrile convulsions, Week 48 | 0 | 0 | 0 |
Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| Any, Week 37 | 0 | 0 | 0 |
| Any, Week 38 | 22 | 0 | 0 |
| Any, Week 39 | 74 | 1 | 0 |
| Any, Week 40 | 120 | 2 | 0 |
| Any, Week 41 | 151 | 2 | 3 |
| Any, Week 42 | 168 | 3 | 3 |
| Any, Week 43 | 181 | 4 | 5 |
| Any, Week 44 | 188 | 5 | 5 |
| Any, Week 45 | 201 | 5 | 5 |
| Any, Week 46 | 204 | 6 | 5 |
| Any, Week 47 | 205 | 6 | 5 |
| Any, Week 48 | 206 | 6 | 5 |
| Bell's palsy, Week 37 | 0 | 0 | 0 |
| Bell's palsy, Week 38 | 0 | 0 | 0 |
| Bell's palsy, Week 39 | 0 | 0 | 0 |
| Bell's palsy, Week 40 | 0 | 0 | 0 |
| Bell's palsy, Week 41 | 0 | 0 | 0 |
| Bell's palsy, Week 42 | 0 | 0 | 0 |
| Bell's palsy, Week 43 | 0 | 0 | 0 |
| Bell's palsy, Week 44 | 0 | 0 | 0 |
| Bell's palsy, Week 45 | 0 | 0 | 0 |
| Bell's palsy, Week 46 | 0 | 0 | 0 |
| Bell's palsy, Week 47 | 0 | 0 | 0 |
| Bell's palsy, Week 48 | 0 | 0 | 0 |
| Guillain-Barre Syndrome, Week 37 | 0 | 0 | 0 |
| Guillain-Barre Syndrome, Week 38 | 0 | 0 | 0 |
| Guillain-Barre Syndrome, Week 39 | 0 | 0 | 0 |
| Guillain-Barre Syndrome, Week 40 | 0 | 0 | 0 |
| Guillain-Barre Syndrome, Week 41 | 0 | 0 | 0 |
| Guillain-Barre Syndrome, Week 42 | 0 | 0 | 0 |
| Guillain-Barre Syndrome, Week 43 | 0 | 0 | 0 |
| Guillain-Barre Syndrome, Week 44 | 0 | 0 | 0 |
| Guillain-Barre Syndrome, Week 45 | 0 | 0 | 0 |
| Guillain-Barre Syndrome, Week 46 | 0 | 0 | 0 |
| Guillain-Barre Syndrome, Week 47 | 0 | 0 | 0 |
| Guillain-Barre Syndrome, Week 48 | 0 | 0 | 0 |
| Headache, Week 37 | 0 | 0 | 0 |
| Headache, Week 38 | 20 | 0 | 0 |
| Headache, Week 39 | 72 | 1 | 0 |
| Headache, Week 40 | 116 | 2 | 0 |
| Headache, Week 41 | 144 | 2 | 3 |
| Headache, Week 42 | 159 | 3 | 3 |
| Headache, Week 43 | 170 | 4 | 5 |
| Headache, Week 44 | 176 | 5 | 5 |
| Headache, Week 45 | 187 | 5 | 5 |
| Headache, Week 46 | 190 | 6 | 5 |
| Headache, Week 47 | 191 | 6 | 5 |
| Headache, Week 48 | 192 | 6 | 5 |
| Peripheral tremor, Week 37 | 0 | 0 | 0 |
| Peripheral tremor, Week 38 | 3 | 0 | 0 |
| Peripheral tremor, Week 39 | 8 | 0 | 0 |
| Peripheral tremor, Week 40 | 9 | 0 | 0 |
| Peripheral tremor, Week 41 | 17 | 0 | 0 |
| Peripheral tremor, Week 42 | 20 | 0 | 0 |
| Peripheral tremor, Week 43 | 22 | 0 | 0 |
| Peripheral tremor, Week 44 | 23 | 0 | 0 |
| Peripheral tremor, Week 45 | 24 | 0 | 0 |
| Peripheral tremor, Week 46 | 24 | 0 | 0 |
| Peripheral tremor, Week 47 | 24 | 0 | 0 |
| Peripheral tremor, Week 48 | 24 | 0 | 0 |
| Seizure / Febrile convulsions, Week 37 | 0 | 0 | 0 |
| Seizure / Febrile convulsions, Week 38 | 0 | 0 | 0 |
| Seizure / Febrile convulsions, Week 39 | 0 | 0 | 0 |
| Seizure / Febrile convulsions, Week 40 | 1 | 0 | 0 |
| Seizure / Febrile convulsions, Week 41 | 1 | 0 | 0 |
| Seizure / Febrile convulsions, Week 42 | 1 | 0 | 0 |
| Seizure / Febrile convulsions, Week 43 | 1 | 0 | 0 |
| Seizure / Febrile convulsions, Week 44 | 1 | 0 | 0 |
| Seizure / Febrile convulsions, Week 45 | 2 | 0 | 0 |
| Seizure / Febrile convulsions, Week 46 | 2 | 0 | 0 |
| Seizure / Febrile convulsions, Week 47 | 2 | 0 | 0 |
| Seizure / Febrile convulsions, Week 48 | 2 | 0 | 0 |
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| 6 months - 5 years, Week 37 | 0 | 0 | 0 |
| 6 months - 5 years, Week 38 | 0 | 0 | 0 |
| 6 months - 5 years, Week 39 | 0 | 0 | 0 |
| 6 months - 5 years, Week 40 | 0 | 2 | 0 |
| 6 months - 5 years, Week 41 | 0 | 3 | 0 |
| 6 months - 5 years, Week 42 | 1 | 6 | 0 |
| 6 months - 5 years, Week 43 | 0 | 0 | 0 |
| 6 months - 5 years, Week 44 | 0 | 4 | 1 |
| 6 months - 5 years, Week 45 | 0 | 2 | 2 |
| 6 months - 5 years, Week 46 | 0 | 4 | 0 |
| 6 months - 5 years, Week 47 | 1 | 0 | 0 |
| 6 months - 5 years, Week 48 | 0 | 2 | 0 |
| 6-12 years, Week 37 | 0 | 0 | 0 |
| 6-12 years, Week 38 | 0 | 0 | 0 |
| 6-12 years, Week 39 | 0 | 0 | 0 |
| 6-12 years, Week 40 | 1 | 2 | 0 |
| 6-12 years, Week 41 | 0 | 0 | 1 |
| 6-12 years, Week 42 | 0 | 0 | 0 |
| 6-12 years, Week 43 | 1 | 1 | 1 |
| 6-12 years, Week 44 | 0 | 1 | 0 |
| 6-12 years, Week 45 | 0 | 0 | 0 |
| 6-12 years, Week 46 | 1 | 0 | 1 |
| 6-12 years, Week 47 | 0 | 2 | 1 |
| 6-12 years, Week 48 | 0 | 0 | 2 |
| 13-17 years, Week 37 | 0 | 0 | 0 |
| 13-17 years, Week 38 | 0 | 0 | 0 |
| 13-17 years, Week 39 | 0 | 0 | 0 |
| 13-17 years, Week 40 | 0 | 0 | 0 |
| 13-17 years, Week 41 | 0 | 0 | 0 |
| 13-17 years, Week 42 | 1 | 2 | 0 |
| 13-17 years, Week 43 | 0 | 0 | 0 |
| 13-17 years, Week 44 | 0 | 0 | 0 |
| 13-17 years, Week 45 | 0 | 0 | 0 |
| 13-17 years, Week 46 | 0 | 1 | 0 |
| 13-17 years, Week 47 | 0 | 0 | 0 |
| 13-17 years, Week 48 | 0 | 0 | 0 |
| 18-65 years, Week 37 | 0 | 0 | 0 |
| 18-65 years, Week 38 | 28 | 3 | 2 |
| 18-65 years, Week 39 | 67 | 6 | 1 |
| 18-65 years, Week 40 | 77 | 5 | 1 |
| 18-65 years, Week 41 | 60 | 1 | 3 |
| 18-65 years, Week 42 | 49 | 1 | 3 |
| 18-65 years, Week 43 | 23 | 1 | 4 |
| 18-65 years, Week 44 | 21 | 0 | 2 |
| 18-65 years, Week 45 | 27 | 0 | 0 |
| 18-65 years, Week 46 | 21 | 1 | 1 |
| 18-65 years, Week 47 | 5 | 0 | 1 |
| 18-65 years, Week 48 | 6 | 0 | 0 |
| >65 years, Week 37 | 0 | 0 | 0 |
| >65 years, Week 38 | 59 | 1 | 5 |
| >65 years, Week 39 | 160 | 4 | 2 |
| >65 years, Week 40 | 140 | 2 | 3 |
| >65 years, Week 41 | 112 | 1 | 3 |
| >65 years, Week 42 | 67 | 1 | 5 |
| >65 years, Week 43 | 33 | 2 | 5 |
| >65 years, Week 44 | 31 | 1 | 1 |
| >65 years, Week 45 | 27 | 0 | 2 |
| >65 years, Week 46 | 15 | 0 | 0 |
| >65 years, Week 47 | 8 | 0 | 0 |
| >65 years, Week 48 | 7 | 0 | 0 |
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| 6 months - 5 years, Week 37 | 0 | 0 | 0 |
| 6 months - 5 years, Week 38 | 0 | 0 | 0 |
| 6 months - 5 years, Week 39 | 0 | 0 | 0 |
| 6 months - 5 years, Week 40 | 0 | 2 | 0 |
| 6 months - 5 years, Week 41 | 0 | 5 | 0 |
| 6 months - 5 years, Week 42 | 1 | 11 | 0 |
| 6 months - 5 years, Week 43 | 1 | 11 | 0 |
| 6 months - 5 years, Week 44 | 1 | 15 | 1 |
| 6 months - 5 years, Week 45 | 1 | 17 | 3 |
| 6 months - 5 years, Week 46 | 1 | 21 | 3 |
| 6 months - 5 years, Week 47 | 2 | 21 | 4 |
| 6 months - 5 years, Week 48 | 2 | 23 | 4 |
| 6-12 years, Week 37 | 0 | 0 | 0 |
| 6-12 years, Week 38 | 0 | 0 | 0 |
| 6-12 years, Week 39 | 0 | 0 | 0 |
| 6-12 years, Week 40 | 1 | 2 | 0 |
| 6-12 years, Week 41 | 1 | 2 | 1 |
| 6-12 years, Week 42 | 1 | 2 | 1 |
| 6-12 years, Week 43 | 2 | 3 | 2 |
| 6-12 years, Week 44 | 2 | 4 | 2 |
| 6-12 years, Week 45 | 2 | 4 | 2 |
| 6-12 years, Week 46 | 3 | 4 | 3 |
| 6-12 years, Week 47 | 3 | 6 | 2 |
| 6-12 years, Week 48 | 3 | 6 | 6 |
| 13-17 years, Week 37 | 0 | 0 | 0 |
| 13-17 years, Week 38 | 0 | 0 | 0 |
| 13-17 years, Week 39 | 0 | 0 | 0 |
| 13-17 years, Week 40 | 0 | 0 | 0 |
| 13-17 years, Week 41 | 0 | 0 | 0 |
| 13-17 years, Week 42 | 1 | 2 | 0 |
| 13-17 years, Week 43 | 1 | 2 | 0 |
| 13-17 years, Week 44 | 1 | 2 | 0 |
| 13-17 years, Week 45 | 1 | 2 | 0 |
| 13-17 years, Week 46 | 1 | 3 | 0 |
| 13-17 years, Week 47 | 1 | 3 | 0 |
| 13-17 years, Week 48 | 1 | 3 | 0 |
| 18-65 years, Week 37 | 0 | 0 | 0 |
| 18-65 years, Week 38 | 28 | 3 | 2 |
| 18-65 years, Week 39 | 95 | 9 | 3 |
| 18-65 years, Week 40 | 172 | 14 | 4 |
| 18-65 years, Week 41 | 232 | 15 | 7 |
| 18-65 years, Week 42 | 281 | 16 | 10 |
| 18-65 years, Week 43 | 304 | 17 | 14 |
| 18-65 years, Week 44 | 325 | 17 | 16 |
| 18-65 years, Week 45 | 352 | 17 | 16 |
| 18-65 years, Week 46 | 373 | 18 | 17 |
| 18-65 years, Week 47 | 378 | 18 | 18 |
| 18-65 years, Week 48 | 384 | 18 | 18 |
| >65 years, Week 37 | 0 | 0 | 0 |
| >65 years, Week 38 | 59 | 1 | 5 |
| >65 years, Week 39 | 219 | 5 | 7 |
| >65 years, Week 40 | 359 | 7 | 10 |
| >65 years, Week 41 | 471 | 8 | 13 |
| >65 years, Week 42 | 538 | 9 | 18 |
| >65 years, Week 43 | 571 | 11 | 23 |
| >65 years, Week 44 | 602 | 12 | 24 |
| >65 years, Week 45 | 629 | 12 | 26 |
| >65 years, Week 46 | 644 | 12 | 26 |
| >65 years, Week 47 | 652 | 12 | 26 |
| >65 years, Week 48 | 659 | 12 | 26 |
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| 6 months - 5 years, Week 37 | 0 | 0 | 0 |
| 6 months - 5 years, Week 38 | 0 | 0 | 0 |
| 6 months - 5 years, Week 39 | 0 | 0 | 0 |
| 6 months - 5 years, Week 40 | 0 | 1 | 0 |
| 6 months - 5 years, Week 41 | 0 | 3 | 0 |
| 6 months - 5 years, Week 42 | 1 | 3 | 0 |
| 6 months - 5 years, Week 43 | 0 | 0 | 0 |
| 6 months - 5 years, Week 44 | 0 | 1 | 1 |
| 6 months - 5 years, Week 45 | 0 | 2 | 2 |
| 6 months - 5 years, Week 46 | 0 | 1 | 0 |
| 6 months - 5 years, Week 47 | 0 | 0 | 1 |
| 6 months - 5 years, Week 48 | 0 | 1 | 0 |
| 6-12 years, Week 37 | 0 | 0 | 0 |
| 6-12 years, Week 38 | 0 | 0 | 0 |
| 6-12 years, Week 39 | 0 | 0 | 0 |
| 6-12 years, Week 40 | 1 | 1 | 0 |
| 6-12 years, Week 41 | 0 | 0 | 0 |
| 6-12 years, Week 42 | 0 | 0 | 0 |
| 6-12 years, Week 43 | 0 | 0 | 0 |
| 6-12 years, Week 44 | 0 | 0 | 0 |
| 6-12 years, Week 45 | 0 | 0 | 0 |
| 6-12 years, Week 46 | 0 | 0 | 0 |
| 6-12 years, Week 47 | 0 | 0 | 0 |
| 6-12 years, Week 48 | 0 | 0 | 2 |
| 13-17 years, Week 37 | 0 | 0 | 0 |
| 13-17 years, Week 38 | 0 | 0 | 0 |
| 13-17 years, Week 39 | 0 | 0 | 0 |
| 13-17 years, Week 40 | 0 | 0 | 0 |
| 13-17 years, Week 41 | 0 | 0 | 0 |
| 13-17 years, Week 42 | 0 | 0 | 0 |
| 13-17 years, Week 43 | 0 | 0 | 0 |
| 13-17 years, Week 44 | 0 | 0 | 0 |
| 13-17 years, Week 45 | 0 | 0 | 0 |
| 13-17 years, Week 46 | 0 | 0 | 0 |
| 13-17 years, Week 47 | 0 | 0 | 0 |
| 13-17 years, Week 48 | 0 | 0 | 0 |
| 18-65 years, Week 37 | 0 | 0 | 0 |
| 18-65 years, Week 38 | 3 | 2 | 0 |
| 18-65 years, Week 39 | 13 | 4 | 0 |
| 18-65 years, Week 40 | 7 | 2 | 0 |
| 18-65 years, Week 41 | 8 | 0 | 1 |
| 18-65 years, Week 42 | 7 | 0 | 1 |
| 18-65 years, Week 43 | 5 | 0 | 1 |
| 18-65 years, Week 44 | 4 | 0 | 2 |
| 18-65 years, Week 45 | 3 | 0 | 0 |
| 18-65 years, Week 46 | 6 | 0 | 0 |
| 18-65 years, Week 47 | 1 | 0 | 0 |
| 18-65 years, Week 48 | 3 | 0 | 0 |
| >65 years, Week 37 | 0 | 0 | 0 |
| >65 years, Week 38 | 5 | 0 | 2 |
| >65 years, Week 39 | 10 | 1 | 0 |
| >65 years, Week 40 | 14 | 1 | 0 |
| >65 years, Week 41 | 12 | 0 | 0 |
| >65 years, Week 42 | 7 | 0 | 1 |
| >65 years, Week 43 | 8 | 0 | 2 |
| >65 years, Week 44 | 2 | 1 | 0 |
| >65 years, Week 45 | 5 | 0 | 0 |
| >65 years, Week 46 | 5 | 0 | 0 |
| >65 years, Week 47 | 1 | 0 | 0 |
| >65 years, Week 48 | 2 | 0 | 0 |
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| 6 months - 5 years, Week 37 | 0 | 0 | 0 |
| 6 months - 5 years, Week 38 | 0 | 0 | 0 |
| 6 months - 5 years, Week 39 | 0 | 0 | 0 |
| 6 months - 5 years, Week 40 | 0 | 1 | 0 |
| 6 months - 5 years, Week 41 | 0 | 4 | 0 |
| 6 months - 5 years, Week 42 | 1 | 8 | 0 |
| 6 months - 5 years, Week 43 | 1 | 8 | 0 |
| 6 months - 5 years, Week 44 | 1 | 9 | 1 |
| 6 months - 5 years, Week 45 | 1 | 11 | 3 |
| 6 months - 5 years, Week 46 | 1 | 12 | 3 |
| 6 months - 5 years, Week 47 | 1 | 12 | 4 |
| 6 months - 5 years, Week 48 | 1 | 13 | 4 |
| 6-12 years, Week 37 | 0 | 0 | 0 |
| 6-12 years, Week 38 | 0 | 0 | 0 |
| 6-12 years, Week 39 | 0 | 0 | 0 |
| 6-12 years, Week 40 | 1 | 1 | 0 |
| 6-12 years, Week 41 | 1 | 1 | 0 |
| 6-12 years, Week 42 | 1 | 1 | 0 |
| 6-12 years, Week 43 | 1 | 1 | 0 |
| 6-12 years, Week 44 | 1 | 1 | 0 |
| 6-12 years, Week 45 | 1 | 1 | 0 |
| 6-12 years, Week 46 | 1 | 1 | 0 |
| 6-12 years, Week 47 | 1 | 1 | 0 |
| 6-12 years, Week 48 | 1 | 1 | 2 |
| 13-17 years, Week 37 | 0 | 0 | 0 |
| 13-17 years, Week 38 | 0 | 0 | 0 |
| 13-17 years, Week 39 | 0 | 0 | 0 |
| 13-17 years, Week 40 | 0 | 0 | 0 |
| 13-17 years, Week 41 | 0 | 0 | 0 |
| 13-17 years, Week 42 | 0 | 0 | 0 |
| 13-17 years, Week 43 | 0 | 0 | 0 |
| 13-17 years, Week 44 | 0 | 0 | 0 |
| 13-17 years, Week 45 | 0 | 0 | 0 |
| 13-17 years, Week 46 | 0 | 0 | 0 |
| 13-17 years, Week 47 | 0 | 0 | 0 |
| 13-17 years, Week 48 | 0 | 0 | 0 |
| 18-65 years, Week 37 | 0 | 0 | 0 |
| 18-65 years, Week 38 | 3 | 2 | 0 |
| 18-65 years, Week 39 | 16 | 6 | 0 |
| 18-65 years, Week 40 | 23 | 8 | 0 |
| 18-65 years, Week 41 | 31 | 8 | 1 |
| 18-65 years, Week 42 | 38 | 8 | 2 |
| 18-65 years, Week 43 | 43 | 8 | 3 |
| 18-65 years, Week 44 | 47 | 8 | 5 |
| 18-65 years, Week 45 | 50 | 8 | 5 |
| 18-65 years, Week 46 | 56 | 8 | 5 |
| 18-65 years, Week 47 | 57 | 8 | 5 |
| 18-65 years, Week 48 | 60 | 8 | 5 |
| >65 years, Week 37 | 0 | 0 | 0 |
| >65 years, Week 38 | 5 | 0 | 2 |
| >65 years, Week 39 | 15 | 1 | 2 |
| >65 years, Week 40 | 29 | 2 | 2 |
| >65 years, Week 41 | 41 | 2 | 2 |
| >65 years, Week 42 | 48 | 2 | 3 |
| >65 years, Week 43 | 56 | 2 | 5 |
| >65 years, Week 44 | 58 | 3 | 5 |
| >65 years, Week 45 | 63 | 3 | 5 |
| >65 years, Week 46 | 68 | 3 | 5 |
| >65 years, Week 47 | 69 | 3 | 5 |
| >65 years, Week 48 | 71 | 3 | 5 |
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| 6 months - 5 years, Week 37 | 0 | 0 | 0 |
| 6 months - 5 years, Week 38 | 0 | 0 | 0 |
| 6 months - 5 years, Week 39 | 0 | 0 | 0 |
| 6 months - 5 years, Week 40 | 0 | 0 | 0 |
| 6 months - 5 years, Week 41 | 0 | 0 | 0 |
| 6 months - 5 years, Week 42 | 0 | 0 | 0 |
| 6 months - 5 years, Week 43 | 0 | 0 | 0 |
| 6 months - 5 years, Week 44 | 0 | 0 | 0 |
| 6 months - 5 years, Week 45 | 0 | 0 | 0 |
| 6 months - 5 years, Week 46 | 0 | 0 | 0 |
| 6 months - 5 years, Week 47 | 0 | 0 | 0 |
| 6 months - 5 years, Week 48 | 0 | 0 | 0 |
| 6-12 years, Week 37 | 0 | 0 | 0 |
| 6-12 years, Week 38 | 0 | 0 | 0 |
| 6-12 years, Week 39 | 0 | 0 | 0 |
| 6-12 years, Week 40 | 0 | 0 | 0 |
| 6-12 years, Week 41 | 0 | 0 | 0 |
| 6-12 years, Week 42 | 0 | 0 | 0 |
| 6-12 years, Week 43 | 0 | 0 | 0 |
| 6-12 years, Week 44 | 0 | 0 | 0 |
| 6-12 years, Week 45 | 0 | 0 | 0 |
| 6-12 years, Week 46 | 0 | 0 | 0 |
| 6-12 years, Week 47 | 0 | 0 | 0 |
| 6-12 years, Week 48 | 0 | 0 | 0 |
| 13-17 years, Week 37 | 0 | 0 | 0 |
| 13-17 years, Week 38 | 0 | 0 | 0 |
| 13-17 years, Week 39 | 0 | 0 | 0 |
| 13-17 years, Week 40 | 0 | 0 | 0 |
| 13-17 years, Week 41 | 0 | 0 | 0 |
| 13-17 years, Week 42 | 0 | 0 | 0 |
| 13-17 years, Week 43 | 0 | 0 | 0 |
| 13-17 years, Week 44 | 0 | 0 | 0 |
| 13-17 years, Week 45 | 0 | 0 | 0 |
| 13-17 years, Week 46 | 0 | 0 | 0 |
| 13-17 years, Week 47 | 0 | 0 | 0 |
| 13-17 years, Week 48 | 0 | 0 | 0 |
| 18-65 years, Week 37 | 0 | 0 | 0 |
| 18-65 years, Week 38 | 9 | 0 | 0 |
| 18-65 years, Week 39 | 8 | 0 | 0 |
| 18-65 years, Week 40 | 10 | 0 | 0 |
| 18-65 years, Week 41 | 12 | 0 | 0 |
| 18-65 years, Week 42 | 9 | 0 | 0 |
| 18-65 years, Week 43 | 1 | 0 | 0 |
| 18-65 years, Week 44 | 4 | 0 | 0 |
| 18-65 years, Week 45 | 3 | 0 | 0 |
| 18-65 years, Week 46 | 3 | 0 | 0 |
| 18-65 years, Week 47 | 0 | 0 | 0 |
| 18-65 years, Week 48 | 0 | 0 | 0 |
| >65 years, Week 37 | 0 | 0 | 0 |
| >65 years, Week 38 | 7 | 0 | 0 |
| >65 years, Week 39 | 12 | 0 | 0 |
| >65 years, Week 40 | 14 | 0 | 0 |
| >65 years, Week 41 | 16 | 0 | 0 |
| >65 years, Week 42 | 6 | 0 | 0 |
| >65 years, Week 43 | 5 | 0 | 0 |
| >65 years, Week 44 | 3 | 0 | 0 |
| >65 years, Week 45 | 5 | 0 | 0 |
| >65 years, Week 46 | 0 | 0 | 0 |
| >65 years, Week 47 | 0 | 0 | 0 |
| >65 years, Week 48 | 0 | 0 | 0 |
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| 6 months - 5 years, Week 37 | 0 | 0 | 0 |
| 6 months - 5 years, Week 38 | 0 | 0 | 0 |
| 6 months - 5 years, Week 39 | 0 | 0 | 0 |
| 6 months - 5 years, Week 40 | 0 | 0 | 0 |
| 6 months - 5 years, Week 41 | 0 | 0 | 0 |
| 6 months - 5 years, Week 42 | 0 | 0 | 0 |
| 6 months - 5 years, Week 43 | 0 | 0 | 0 |
| 6 months - 5 years, Week 44 | 0 | 0 | 0 |
| 6 months - 5 years, Week 45 | 0 | 0 | 0 |
| 6 months - 5 years, Week 46 | 0 | 0 | 0 |
| 6 months - 5 years, Week 47 | 0 | 0 | 0 |
| 6 months - 5 years, Week 48 | 0 | 0 | 0 |
| 6-12 years, Week 37 | 0 | 0 | 0 |
| 6-12 years, Week 38 | 0 | 0 | 0 |
| 6-12 years, Week 39 | 0 | 0 | 0 |
| 6-12 years, Week 40 | 0 | 0 | 0 |
| 6-12 years, Week 41 | 0 | 0 | 0 |
| 6-12 years, Week 42 | 0 | 0 | 0 |
| 6-12 years, Week 43 | 0 | 0 | 0 |
| 6-12 years, Week 44 | 0 | 0 | 0 |
| 6-12 years, Week 45 | 0 | 0 | 0 |
| 6-12 years, Week 46 | 0 | 0 | 0 |
| 6-12 years, Week 47 | 0 | 0 | 0 |
| 6-12 years, Week 48 | 0 | 0 | 0 |
| 13-17 years, Week 37 | 0 | 0 | 0 |
| 13-17 years, Week 38 | 0 | 0 | 0 |
| 13-17 years, Week 39 | 0 | 0 | 0 |
| 13-17 years, Week 40 | 0 | 0 | 0 |
| 13-17 years, Week 41 | 0 | 0 | 0 |
| 13-17 years, Week 42 | 0 | 0 | 0 |
| 13-17 years, Week 43 | 0 | 0 | 0 |
| 13-17 years, Week 44 | 0 | 0 | 0 |
| 13-17 years, Week 45 | 0 | 0 | 0 |
| 13-17 years, Week 46 | 0 | 0 | 0 |
| 13-17 years, Week 47 | 0 | 0 | 0 |
| 13-17 years, Week 48 | 0 | 0 | 0 |
| 18-65 years, Week 37 | 0 | 0 | 0 |
| 18-65 years, Week 38 | 9 | 0 | 0 |
| 18-65 years, Week 39 | 17 | 0 | 0 |
| 18-65 years, Week 40 | 27 | 0 | 0 |
| 18-65 years, Week 41 | 39 | 0 | 0 |
| 18-65 years, Week 42 | 48 | 0 | 0 |
| 18-65 years, Week 43 | 49 | 0 | 0 |
| 18-65 years, Week 44 | 53 | 0 | 0 |
| 18-65 years, Week 45 | 56 | 0 | 0 |
| 18-65 years, Week 46 | 59 | 0 | 0 |
| 18-65 years, Week 47 | 59 | 0 | 0 |
| 18-65 years, Week 48 | 59 | 0 | 0 |
| >65 years, Week 37 | 0 | 0 | 0 |
| >65 years, Week 38 | 7 | 0 | 0 |
| >65 years, Week 39 | 19 | 0 | 0 |
| >65 years, Week 40 | 33 | 0 | 0 |
| >65 years, Week 41 | 49 | 0 | 0 |
| >65 years, Week 42 | 55 | 0 | 0 |
| >65 years, Week 43 | 60 | 0 | 0 |
| >65 years, Week 44 | 63 | 0 | 0 |
| >65 years, Week 45 | 68 | 0 | 0 |
| >65 years, Week 46 | 68 | 0 | 0 |
| >65 years, Week 47 | 68 | 0 | 0 |
| >65 years, Week 48 | 68 | 0 | 0 |
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| 6 months - 5 years, Week 37 | 0 | 0 | 0 |
| 6 months - 5 years, Week 38 | 0 | 0 | 0 |
| 6 months - 5 years, Week 39 | 0 | 0 | 0 |
| 6 months - 5 years, Week 40 | 0 | 0 | 0 |
| 6 months - 5 years, Week 41 | 0 | 0 | 0 |
| 6 months - 5 years, Week 42 | 0 | 0 | 0 |
| 6 months - 5 years, Week 43 | 0 | 0 | 0 |
| 6 months - 5 years, Week 44 | 0 | 0 | 0 |
| 6 months - 5 years, Week 45 | 0 | 0 | 0 |
| 6 months - 5 years, Week 46 | 0 | 0 | 0 |
| 6 months - 5 years, Week 47 | 0 | 0 | 0 |
| 6 months - 5 years, Week 48 | 0 | 0 | 0 |
| 6-12 years, Week 37 | 0 | 0 | 0 |
| 6-12 years, Week 38 | 0 | 0 | 0 |
| 6-12 years, Week 39 | 0 | 0 | 0 |
| 6-12 years, Week 40 | 0 | 0 | 0 |
| 6-12 years, Week 41 | 0 | 0 | 0 |
| 6-12 years, Week 42 | 0 | 0 | 0 |
| 6-12 years, Week 43 | 0 | 0 | 0 |
| 6-12 years, Week 44 | 0 | 0 | 0 |
| 6-12 years, Week 45 | 0 | 0 | 0 |
| 6-12 years, Week 46 | 0 | 0 | 0 |
| 6-12 years, Week 47 | 0 | 0 | 0 |
| 6-12 years, Week 48 | 0 | 0 | 0 |
| 13-17 years, Week 37 | 0 | 0 | 0 |
| 13-17 years, Week 38 | 0 | 0 | 0 |
| 13-17 years, Week 39 | 0 | 0 | 0 |
| 13-17 years, Week 40 | 0 | 0 | 0 |
| 13-17 years, Week 41 | 0 | 0 | 0 |
| 13-17 years, Week 42 | 1 | 0 | 0 |
| 13-17 years, Week 43 | 0 | 0 | 0 |
| 13-17 years, Week 44 | 0 | 0 | 0 |
| 13-17 years, Week 45 | 0 | 0 | 0 |
| 13-17 years, Week 46 | 0 | 0 | 0 |
| 13-17 years, Week 47 | 0 | 0 | 0 |
| 13-17 years, Week 48 | 0 | 0 | 0 |
| 18-65 years, Week 37 | 0 | 0 | 0 |
| 18-65 years, Week 38 | 6 | 0 | 0 |
| 18-65 years, Week 39 | 18 | 1 | 0 |
| 18-65 years, Week 40 | 20 | 0 | 0 |
| 18-65 years, Week 41 | 6 | 0 | 0 |
| 18-65 years, Week 42 | 10 | 0 | 1 |
| 18-65 years, Week 43 | 1 | 0 | 0 |
| 18-65 years, Week 44 | 2 | 0 | 0 |
| 18-65 years, Week 45 | 5 | 0 | 0 |
| 18-65 years, Week 46 | 3 | 0 | 0 |
| 18-65 years, Week 47 | 0 | 0 | 0 |
| 18-65 years, Week 48 | 1 | 0 | 0 |
| >65 years, Week 37 | 0 | 0 | 0 |
| >65 years, Week 38 | 15 | 0 | 0 |
| >65 years, Week 39 | 33 | 0 | 0 |
| >65 years, Week 40 | 28 | 0 | 0 |
| >65 years, Week 41 | 22 | 0 | 0 |
| >65 years, Week 42 | 11 | 0 | 0 |
| >65 years, Week 43 | 4 | 0 | 0 |
| >65 years, Week 44 | 5 | 0 | 0 |
| >65 years, Week 45 | 5 | 0 | 0 |
| >65 years, Week 46 | 4 | 0 | 0 |
| >65 years, Week 47 | 2 | 0 | 0 |
| >65 years, Week 48 | 0 | 0 | 0 |
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| 6 months - 5 years, Week 37 | 0 | 0 | 0 |
| 6 months - 5 years, Week 38 | 0 | 0 | 0 |
| 6 months - 5 years, Week 39 | 0 | 0 | 0 |
| 6 months - 5 years, Week 40 | 0 | 0 | 0 |
| 6 months - 5 years, Week 41 | 0 | 0 | 0 |
| 6 months - 5 years, Week 42 | 0 | 0 | 0 |
| 6 months - 5 years, Week 43 | 0 | 0 | 0 |
| 6 months - 5 years, Week 44 | 0 | 0 | 0 |
| 6 months - 5 years, Week 45 | 0 | 0 | 0 |
| 6 months - 5 years, Week 46 | 0 | 0 | 0 |
| 6 months - 5 years, Week 47 | 0 | 0 | 0 |
| 6 months - 5 years, Week 48 | 0 | 0 | 0 |
| 6-12 years, Week 37 | 0 | 0 | 0 |
| 6-12 years, Week 38 | 0 | 0 | 0 |
| 6-12 years, Week 39 | 0 | 0 | 0 |
| 6-12 years, Week 40 | 0 | 0 | 0 |
| 6-12 years, Week 41 | 0 | 0 | 0 |
| 6-12 years, Week 42 | 0 | 0 | 0 |
| 6-12 years, Week 43 | 0 | 0 | 0 |
| 6-12 years, Week 44 | 0 | 0 | 0 |
| 6-12 years, Week 45 | 0 | 0 | 0 |
| 6-12 years, Week 46 | 0 | 0 | 0 |
| 6-12 years, Week 47 | 0 | 0 | 0 |
| 6-12 years, Week 48 | 0 | 0 | 0 |
| 13-17 years, Week 37 | 0 | 0 | 0 |
| 13-17 years, Week 38 | 0 | 0 | 0 |
| 13-17 years, Week 39 | 0 | 0 | 0 |
| 13-17 years, Week 40 | 0 | 0 | 0 |
| 13-17 years, Week 41 | 0 | 0 | 0 |
| 13-17 years, Week 42 | 1 | 0 | 0 |
| 13-17 years, Week 43 | 1 | 0 | 0 |
| 13-17 years, Week 44 | 1 | 0 | 0 |
| 13-17 years, Week 45 | 1 | 0 | 0 |
| 13-17 years, Week 46 | 1 | 0 | 0 |
| 13-17 years, Week 47 | 1 | 0 | 0 |
| 13-17 years, Week 48 | 1 | 0 | 0 |
| 18-65 years, Week 37 | 0 | 0 | 0 |
| 18-65 years, Week 38 | 6 | 0 | 0 |
| 18-65 years, Week 39 | 24 | 1 | 0 |
| 18-65 years, Week 40 | 44 | 1 | 0 |
| 18-65 years, Week 41 | 50 | 1 | 0 |
| 18-65 years, Week 42 | 60 | 1 | 1 |
| 18-65 years, Week 43 | 61 | 1 | 1 |
| 18-65 years, Week 44 | 63 | 1 | 1 |
| 18-65 years, Week 45 | 68 | 1 | 1 |
| 18-65 years, Week 46 | 71 | 1 | 1 |
| 18-65 years, Week 47 | 71 | 1 | 1 |
| 18-65 years, Week 48 | 72 | 1 | 1 |
| >65 years, Week 37 | 0 | 0 | 0 |
| >65 years, Week 38 | 15 | 0 | 0 |
| >65 years, Week 39 | 48 | 0 | 0 |
| >65 years, Week 40 | 76 | 0 | 0 |
| >65 years, Week 41 | 98 | 0 | 0 |
| >65 years, Week 42 | 109 | 0 | 0 |
| >65 years, Week 43 | 113 | 0 | 0 |
| >65 years, Week 44 | 118 | 0 | 0 |
| >65 years, Week 45 | 123 | 0 | 0 |
| >65 years, Week 46 | 127 | 0 | 0 |
| >65 years, Week 47 | 129 | 0 | 0 |
| >65 years, Week 48 | 129 | 0 | 0 |
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| 6 months - 5 years, Week 37 | 0 | 0 | 0 |
| 6 months - 5 years, Week 38 | 0 | 0 | 0 |
| 6 months - 5 years, Week 39 | 0 | 0 | 0 |
| 6 months - 5 years, Week 40 | 0 | 0 | 0 |
| 6 months - 5 years, Week 41 | 0 | 1 | 0 |
| 6 months - 5 years, Week 42 | 0 | 1 | 0 |
| 6 months - 5 years, Week 43 | 0 | 0 | 0 |
| 6 months - 5 years, Week 44 | 0 | 2 | 0 |
| 6 months - 5 years, Week 45 | 0 | 0 | 0 |
| 6 months - 5 years, Week 46 | 0 | 3 | 0 |
| 6 months - 5 years, Week 47 | 0 | 0 | 0 |
| 6 months - 5 years, Week 48 | 0 | 1 | 0 |
| 6-12 years, Week 37 | 0 | 0 | 0 |
| 6-12 years, Week 38 | 0 | 0 | 0 |
| 6-12 years, Week 39 | 0 | 0 | 0 |
| 6-12 years, Week 40 | 0 | 1 | 0 |
| 6-12 years, Week 41 | 0 | 0 | 0 |
| 6-12 years, Week 42 | 0 | 0 | 0 |
| 6-12 years, Week 43 | 0 | 0 | 1 |
| 6-12 years, Week 44 | 0 | 1 | 0 |
| 6-12 years, Week 45 | 0 | 0 | 0 |
| 6-12 years, Week 46 | 0 | 0 | 0 |
| 6-12 years, Week 47 | 0 | 2 | 0 |
| 6-12 years, Week 48 | 0 | 0 | 0 |
| 13-17 years, Week 37 | 0 | 0 | 0 |
| 13-17 years, Week 38 | 0 | 0 | 0 |
| 13-17 years, Week 39 | 0 | 0 | 0 |
| 13-17 years, Week 40 | 0 | 0 | 0 |
| 13-17 years, Week 41 | 0 | 0 | 0 |
| 13-17 years, Week 42 | 1 | 2 | 0 |
| 13-17 years, Week 43 | 0 | 0 | 0 |
| 13-17 years, Week 44 | 0 | 0 | 0 |
| 13-17 years, Week 45 | 0 | 0 | 0 |
| 13-17 years, Week 46 | 0 | 0 | 0 |
| 13-17 years, Week 47 | 0 | 0 | 0 |
| 13-17 years, Week 48 | 0 | 0 | 0 |
| 18-65 years, Week 37 | 0 | 0 | 0 |
| 18-65 years, Week 38 | 8 | 0 | 0 |
| 18-65 years, Week 39 | 32 | 1 | 0 |
| 18-65 years, Week 40 | 36 | 0 | 1 |
| 18-65 years, Week 41 | 24 | 0 | 0 |
| 18-65 years, Week 42 | 28 | 1 | 0 |
| 18-65 years, Week 43 | 12 | 0 | 1 |
| 18-65 years, Week 44 | 7 | 0 | 0 |
| 18-65 years, Week 45 | 18 | 0 | 0 |
| 18-65 years, Week 46 | 9 | 0 | 0 |
| 18-65 years, Week 47 | 4 | 0 | 0 |
| 18-65 years, Week 48 | 0 | 0 | 0 |
| >65 years, Week 37 | 0 | 0 | 0 |
| >65 years, Week 38 | 26 | 1 | 1 |
| >65 years, Week 39 | 88 | 2 | 0 |
| >65 years, Week 40 | 75 | 1 | 0 |
| >65 years, Week 41 | 58 | 1 | 2 |
| >65 years, Week 42 | 36 | 0 | 3 |
| >65 years, Week 43 | 17 | 1 | 3 |
| >65 years, Week 44 | 13 | 1 | 1 |
| >65 years, Week 45 | 11 | 0 | 0 |
| >65 years, Week 46 | 4 | 0 | 0 |
| >65 years, Week 47 | 3 | 0 | 0 |
| >65 years, Week 48 | 2 | 0 | 0 |
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| 6 months - 5 years, Week 37 | 0 | 0 | 0 |
| 6 months - 5 years, Week 38 | 0 | 0 | 0 |
| 6 months - 5 years, Week 39 | 0 | 0 | 0 |
| 6 months - 5 years, Week 40 | 0 | 0 | 0 |
| 6 months - 5 years, Week 41 | 0 | 1 | 0 |
| 6 months - 5 years, Week 42 | 0 | 2 | 0 |
| 6 months - 5 years, Week 43 | 0 | 2 | 0 |
| 6 months - 5 years, Week 44 | 0 | 4 | 0 |
| 6 months - 5 years, Week 45 | 0 | 4 | 0 |
| 6 months - 5 years, Week 46 | 0 | 7 | 0 |
| 6 months - 5 years, Week 47 | 0 | 7 | 0 |
| 6 months - 5 years, Week 48 | 0 | 8 | 0 |
| 6-12 years, Week 37 | 0 | 0 | 0 |
| 6-12 years, Week 38 | 0 | 0 | 0 |
| 6-12 years, Week 39 | 0 | 0 | 0 |
| 6-12 years, Week 40 | 0 | 1 | 0 |
| 6-12 years, Week 41 | 0 | 1 | 0 |
| 6-12 years, Week 42 | 0 | 1 | 0 |
| 6-12 years, Week 43 | 0 | 1 | 1 |
| 6-12 years, Week 44 | 0 | 2 | 1 |
| 6-12 years, Week 45 | 0 | 2 | 1 |
| 6-12 years, Week 46 | 1 | 2 | 1 |
| 6-12 years, Week 47 | 1 | 4 | 1 |
| 6-12 years, Week 48 | 1 | 4 | 1 |
| 13-17 years, Week 37 | 0 | 0 | 0 |
| 13-17 years, Week 38 | 0 | 0 | 0 |
| 13-17 years, Week 39 | 0 | 0 | 0 |
| 13-17 years, Week 40 | 0 | 0 | 0 |
| 13-17 years, Week 41 | 0 | 0 | 0 |
| 13-17 years, Week 42 | 1 | 2 | 0 |
| 13-17 years, Week 43 | 1 | 2 | 0 |
| 13-17 years, Week 44 | 1 | 2 | 0 |
| 13-17 years, Week 45 | 1 | 2 | 0 |
| 13-17 years, Week 46 | 1 | 2 | 0 |
| 13-17 years, Week 47 | 1 | 2 | 0 |
| 13-17 years, Week 48 | 1 | 2 | 0 |
| 18-65 years, Week 37 | 0 | 0 | 0 |
| 18-65 years, Week 38 | 8 | 0 | 0 |
| 18-65 years, Week 39 | 40 | 1 | 0 |
| 18-65 years, Week 40 | 76 | 1 | 1 |
| 18-65 years, Week 41 | 100 | 1 | 1 |
| 18-65 years, Week 42 | 128 | 2 | 1 |
| 18-65 years, Week 43 | 140 | 2 | 2 |
| 18-65 years, Week 44 | 147 | 2 | 2 |
| 18-65 years, Week 45 | 165 | 2 | 2 |
| 18-65 years, Week 46 | 174 | 2 | 2 |
| 18-65 years, Week 47 | 178 | 2 | 2 |
| 18-65 years, Week 48 | 178 | 2 | 2 |
| >65 years, Week 37 | 0 | 0 | 0 |
| >65 years, Week 38 | 26 | 1 | 1 |
| >65 years, Week 39 | 114 | 3 | 1 |
| >65 years, Week 40 | 189 | 4 | 1 |
| >65 years, Week 41 | 247 | 5 | 3 |
| >65 years, Week 42 | 283 | 5 | 6 |
| >65 years, Week 43 | 300 | 6 | 9 |
| >65 years, Week 44 | 313 | 7 | 10 |
| >65 years, Week 45 | 324 | 7 | 10 |
| >65 years, Week 46 | 328 | 7 | 10 |
| >65 years, Week 47 | 331 | 7 | 10 |
| >65 years, Week 48 | 333 | 7 | 10 |
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| 6 months - 5 years, Week 37 | 0 | 0 | 0 |
| 6 months - 5 years, Week 38 | 0 | 0 | 0 |
| 6 months - 5 years, Week 39 | 0 | 0 | 0 |
| 6 months - 5 years, Week 40 | 0 | 0 | 0 |
| 6 months - 5 years, Week 41 | 0 | 0 | 0 |
| 6 months - 5 years, Week 42 | 0 | 2 | 0 |
| 6 months - 5 years, Week 43 | 0 | 0 | 0 |
| 6 months - 5 years, Week 44 | 0 | 0 | 0 |
| 6 months - 5 years, Week 45 | 0 | 0 | 0 |
| 6 months - 5 years, Week 46 | 0 | 0 | 0 |
| 6 months - 5 years, Week 47 | 0 | 0 | 0 |
| 6 months - 5 years, Week 48 | 0 | 0 | 0 |
| 6-12 years, Week 37 | 0 | 0 | 0 |
| 6-12 years, Week 38 | 0 | 0 | 0 |
| 6-12 years, Week 39 | 0 | 0 | 0 |
| 6-12 years, Week 40 | 0 | 0 | 0 |
| 6-12 years, Week 41 | 0 | 0 | 0 |
| 6-12 years, Week 42 | 0 | 0 | 0 |
| 6-12 years, Week 43 | 0 | 0 | 0 |
| 6-12 years, Week 44 | 0 | 0 | 0 |
| 6-12 years, Week 45 | 0 | 0 | 0 |
| 6-12 years, Week 46 | 0 | 0 | 0 |
| 6-12 years, Week 47 | 0 | 0 | 0 |
| 6-12 years, Week 48 | 0 | 0 | 0 |
| 13-17 years, Week 37 | 0 | 0 | 0 |
| 13-17 years, Week 38 | 0 | 0 | 0 |
| 13-17 years, Week 39 | 0 | 0 | 0 |
| 13-17 years, Week 40 | 0 | 0 | 0 |
| 13-17 years, Week 41 | 0 | 0 | 0 |
| 13-17 years, Week 42 | 0 | 0 | 0 |
| 13-17 years, Week 43 | 0 | 0 | 0 |
| 13-17 years, Week 44 | 0 | 0 | 0 |
| 13-17 years, Week 45 | 0 | 0 | 0 |
| 13-17 years, Week 46 | 0 | 0 | 0 |
| 13-17 years, Week 47 | 0 | 0 | 0 |
| 13-17 years, Week 48 | 0 | 0 | 0 |
| 18-65 years, Week 37 | 0 | 0 | 0 |
| 18-65 years, Week 38 | 7 | 0 | 0 |
| 18-65 years, Week 39 | 9 | 0 | 0 |
| 18-65 years, Week 40 | 12 | 0 | 0 |
| 18-65 years, Week 41 | 8 | 0 | 0 |
| 18-65 years, Week 42 | 7 | 0 | 0 |
| 18-65 years, Week 43 | 5 | 0 | 0 |
| 18-65 years, Week 44 | 2 | 0 | 0 |
| 18-65 years, Week 45 | 3 | 0 | 0 |
| 18-65 years, Week 46 | 2 | 0 | 1 |
| 18-65 years, Week 47 | 0 | 0 | 0 |
| 18-65 years, Week 48 | 1 | 0 | 0 |
| >65 years, Week 37 | 0 | 0 | 0 |
| >65 years, Week 38 | 11 | 0 | 0 |
| >65 years, Week 39 | 23 | 0 | 0 |
| >65 years, Week 40 | 22 | 0 | 1 |
| >65 years, Week 41 | 17 | 0 | 1 |
| >65 years, Week 42 | 12 | 0 | 0 |
| >65 years, Week 43 | 4 | 0 | 0 |
| >65 years, Week 44 | 3 | 0 | 0 |
| >65 years, Week 45 | 3 | 0 | 0 |
| >65 years, Week 46 | 2 | 0 | 0 |
| >65 years, Week 47 | 1 | 0 | 0 |
| >65 years, Week 48 | 0 | 0 | 0 |
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| 6 months - 5 years, Week 37 | 0 | 0 | 0 |
| 6 months - 5 years, Week 38 | 0 | 0 | 0 |
| 6 months - 5 years, Week 39 | 0 | 0 | 0 |
| 6 months - 5 years, Week 40 | 0 | 0 | 0 |
| 6 months - 5 years, Week 41 | 0 | 0 | 0 |
| 6 months - 5 years, Week 42 | 0 | 2 | 0 |
| 6 months - 5 years, Week 43 | 0 | 2 | 0 |
| 6 months - 5 years, Week 44 | 0 | 2 | 0 |
| 6 months - 5 years, Week 45 | 0 | 2 | 0 |
| 6 months - 5 years, Week 46 | 0 | 2 | 0 |
| 6 months - 5 years, Week 47 | 0 | 2 | 0 |
| 6 months - 5 years, Week 48 | 0 | 2 | 0 |
| 6-12 years, Week 37 | 0 | 0 | 0 |
| 6-12 years, Week 38 | 0 | 0 | 0 |
| 6-12 years, Week 39 | 0 | 0 | 0 |
| 6-12 years, Week 40 | 0 | 0 | 0 |
| 6-12 years, Week 41 | 0 | 0 | 0 |
| 6-12 years, Week 42 | 0 | 0 | 0 |
| 6-12 years, Week 43 | 0 | 0 | 0 |
| 6-12 years, Week 44 | 0 | 0 | 0 |
| 6-12 years, Week 45 | 0 | 0 | 0 |
| 6-12 years, Week 46 | 0 | 0 | 0 |
| 6-12 years, Week 47 | 0 | 0 | 0 |
| 6-12 years, Week 48 | 0 | 0 | 0 |
| 13-17 years, Week 37 | 0 | 0 | 0 |
| 13-17 years, Week 38 | 0 | 0 | 0 |
| 13-17 years, Week 39 | 0 | 0 | 0 |
| 13-17 years, Week 40 | 0 | 0 | 0 |
| 13-17 years, Week 41 | 0 | 0 | 0 |
| 13-17 years, Week 42 | 0 | 0 | 0 |
| 13-17 years, Week 43 | 0 | 0 | 0 |
| 13-17 years, Week 44 | 0 | 0 | 0 |
| 13-17 years, Week 45 | 0 | 0 | 0 |
| 13-17 years, Week 46 | 0 | 0 | 0 |
| 13-17 years, Week 47 | 0 | 0 | 0 |
| 13-17 years, Week 48 | 0 | 0 | 0 |
| 18-65 years, Week 37 | 0 | 0 | 0 |
| 18-65 years, Week 38 | 7 | 0 | 0 |
| 18-65 years, Week 39 | 16 | 0 | 0 |
| 18-65 years, Week 40 | 28 | 0 | 0 |
| 18-65 years, Week 41 | 36 | 0 | 0 |
| 18-65 years, Week 42 | 43 | 0 | 0 |
| 18-65 years, Week 43 | 48 | 0 | 0 |
| 18-65 years, Week 44 | 50 | 0 | 0 |
| 18-65 years, Week 45 | 53 | 0 | 0 |
| 18-65 years, Week 46 | 55 | 0 | 1 |
| 18-65 years, Week 47 | 55 | 0 | 1 |
| 18-65 years, Week 48 | 56 | 0 | 1 |
| >65 years, Week 37 | 0 | 0 | 0 |
| >65 years, Week 38 | 11 | 0 | 0 |
| >65 years, Week 39 | 34 | 0 | 0 |
| >65 years, Week 40 | 56 | 0 | 1 |
| >65 years, Week 41 | 73 | 0 | 2 |
| >65 years, Week 42 | 85 | 0 | 2 |
| >65 years, Week 43 | 89 | 0 | 2 |
| >65 years, Week 44 | 92 | 0 | 2 |
| >65 years, Week 45 | 95 | 0 | 2 |
| >65 years, Week 46 | 97 | 0 | 2 |
| >65 years, Week 47 | 98 | 0 | 2 |
| >65 years, Week 48 | 98 | 0 | 2 |
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| 6 months - 5 years, Week 37 | 0 | 0 | 0 |
| 6 months - 5 years, Week 38 | 0 | 0 | 0 |
| 6 months - 5 years, Week 39 | 0 | 0 | 0 |
| 6 months - 5 years, Week 40 | 0 | 0 | 0 |
| 6 months - 5 years, Week 41 | 0 | 0 | 0 |
| 6 months - 5 years, Week 42 | 0 | 0 | 0 |
| 6 months - 5 years, Week 43 | 0 | 0 | 0 |
| 6 months - 5 years, Week 44 | 0 | 0 | 0 |
| 6 months - 5 years, Week 45 | 0 | 0 | 0 |
| 6 months - 5 years, Week 46 | 0 | 0 | 0 |
| 6 months - 5 years, Week 47 | 0 | 0 | 0 |
| 6 months - 5 years, Week 48 | 0 | 0 | 0 |
| 6-12 years, Week 37 | 0 | 0 | 0 |
| 6-12 years, Week 38 | 0 | 0 | 0 |
| 6-12 years, Week 39 | 0 | 0 | 0 |
| 6-12 years, Week 40 | 0 | 0 | 0 |
| 6-12 years, Week 41 | 0 | 0 | 0 |
| 6-12 years, Week 42 | 0 | 0 | 0 |
| 6-12 years, Week 43 | 0 | 0 | 0 |
| 6-12 years, Week 44 | 0 | 0 | 0 |
| 6-12 years, Week 45 | 0 | 0 | 0 |
| 6-12 years, Week 46 | 0 | 0 | 0 |
| 6-12 years, Week 47 | 0 | 0 | 0 |
| 6-12 years, Week 48 | 0 | 0 | 0 |
| 13-17 years, Week 37 | 0 | 0 | 0 |
| 13-17 years, Week 38 | 0 | 0 | 0 |
| 13-17 years, Week 39 | 0 | 0 | 0 |
| 13-17 years, Week 40 | 0 | 0 | 0 |
| 13-17 years, Week 41 | 0 | 0 | 0 |
| 13-17 years, Week 42 | 0 | 0 | 0 |
| 13-17 years, Week 43 | 0 | 0 | 0 |
| 13-17 years, Week 44 | 0 | 0 | 0 |
| 13-17 years, Week 45 | 0 | 0 | 0 |
| 13-17 years, Week 46 | 0 | 0 | 0 |
| 13-17 years, Week 47 | 0 | 0 | 0 |
| 13-17 years, Week 48 | 0 | 0 | 0 |
| 18-65 years, Week 37 | 0 | 0 | 0 |
| 18-65 years, Week 38 | 1 | 1 | 0 |
| 18-65 years, Week 39 | 1 | 0 | 0 |
| 18-65 years, Week 40 | 2 | 0 | 0 |
| 18-65 years, Week 41 | 0 | 0 | 0 |
| 18-65 years, Week 42 | 2 | 0 | 0 |
| 18-65 years, Week 43 | 1 | 0 | 0 |
| 18-65 years, Week 44 | 1 | 0 | 0 |
| 18-65 years, Week 45 | 0 | 0 | 0 |
| 18-65 years, Week 46 | 1 | 0 | 0 |
| 18-65 years, Week 47 | 0 | 0 | 0 |
| 18-65 years, Week 48 | 0 | 0 | 0 |
| >65 years, Week 37 | 0 | 0 | 0 |
| >65 years, Week 38 | 0 | 0 | 0 |
| >65 years, Week 39 | 1 | 0 | 0 |
| >65 years, Week 40 | 1 | 0 | 0 |
| >65 years, Week 41 | 0 | 0 | 0 |
| >65 years, Week 42 | 1 | 0 | 0 |
| >65 years, Week 43 | 1 | 0 | 0 |
| >65 years, Week 44 | 0 | 0 | 0 |
| >65 years, Week 45 | 1 | 0 | 0 |
| >65 years, Week 46 | 0 | 0 | 0 |
| >65 years, Week 47 | 0 | 0 | 0 |
| >65 years, Week 48 | 1 | 0 | 0 |
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| 6 months - 5 years, Week 37 | 0 | 0 | 0 |
| 6 months - 5 years, Week 38 | 0 | 0 | 0 |
| 6 months - 5 years, Week 39 | 0 | 0 | 0 |
| 6 months - 5 years, Week 40 | 0 | 0 | 0 |
| 6 months - 5 years, Week 41 | 0 | 0 | 0 |
| 6 months - 5 years, Week 42 | 0 | 0 | 0 |
| 6 months - 5 years, Week 43 | 0 | 0 | 0 |
| 6 months - 5 years, Week 44 | 0 | 0 | 0 |
| 6 months - 5 years, Week 45 | 0 | 0 | 0 |
| 6 months - 5 years, Week 46 | 0 | 0 | 0 |
| 6 months - 5 years, Week 47 | 0 | 0 | 0 |
| 6 months - 5 years, Week 48 | 0 | 0 | 0 |
| 6-12 years, Week 37 | 0 | 0 | 0 |
| 6-12 years, Week 38 | 0 | 0 | 0 |
| 6-12 years, Week 39 | 0 | 0 | 0 |
| 6-12 years, Week 40 | 0 | 0 | 0 |
| 6-12 years, Week 41 | 0 | 0 | 0 |
| 6-12 years, Week 42 | 0 | 0 | 0 |
| 6-12 years, Week 43 | 0 | 0 | 0 |
| 6-12 years, Week 44 | 0 | 0 | 0 |
| 6-12 years, Week 45 | 0 | 0 | 0 |
| 6-12 years, Week 46 | 0 | 0 | 0 |
| 6-12 years, Week 47 | 0 | 0 | 0 |
| 6-12 years, Week 48 | 0 | 0 | 0 |
| 13-17 years, Week 37 | 0 | 0 | 0 |
| 13-17 years, Week 38 | 0 | 0 | 0 |
| 13-17 years, Week 39 | 0 | 0 | 0 |
| 13-17 years, Week 40 | 0 | 0 | 0 |
| 13-17 years, Week 41 | 0 | 0 | 0 |
| 13-17 years, Week 42 | 0 | 0 | 0 |
| 13-17 years, Week 43 | 0 | 0 | 0 |
| 13-17 years, Week 44 | 0 | 0 | 0 |
| 13-17 years, Week 45 | 0 | 0 | 0 |
| 13-17 years, Week 46 | 0 | 0 | 0 |
| 13-17 years, Week 47 | 0 | 0 | 0 |
| 13-17 years, Week 48 | 0 | 0 | 0 |
| 18-65 years, Week 37 | 0 | 0 | 0 |
| 18-65 years, Week 38 | 1 | 1 | 0 |
| 18-65 years, Week 39 | 2 | 1 | 0 |
| 18-65 years, Week 40 | 4 | 1 | 0 |
| 18-65 years, Week 41 | 4 | 1 | 0 |
| 18-65 years, Week 42 | 6 | 1 | 0 |
| 18-65 years, Week 43 | 7 | 1 | 0 |
| 18-65 years, Week 44 | 8 | 1 | 0 |
| 18-65 years, Week 45 | 8 | 1 | 0 |
| 18-65 years, Week 46 | 9 | 1 | 0 |
| 18-65 years, Week 47 | 9 | 1 | 0 |
| 18-65 years, Week 48 | 9 | 1 | 0 |
| >65 years, Week 37 | 0 | 0 | 0 |
| >65 years, Week 38 | 0 | 0 | 0 |
| >65 years, Week 39 | 1 | 0 | 0 |
| >65 years, Week 40 | 2 | 0 | 0 |
| >65 years, Week 41 | 2 | 0 | 0 |
| >65 years, Week 42 | 3 | 0 | 0 |
| >65 years, Week 43 | 4 | 0 | 0 |
| >65 years, Week 44 | 4 | 0 | 0 |
| >65 years, Week 45 | 5 | 0 | 0 |
| >65 years, Week 46 | 5 | 0 | 0 |
| >65 years, Week 47 | 5 | 0 | 0 |
| >65 years, Week 48 | 6 | 0 | 0 |
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| 6 months - 5 years, Week 37 | 0 | 0 | 0 |
| 6 months - 5 years, Week 38 | 0 | 0 | 0 |
| 6 months - 5 years, Week 39 | 0 | 0 | 0 |
| 6 months - 5 years, Week 40 | 0 | 2 | 0 |
| 6 months - 5 years, Week 41 | 0 | 0 | 0 |
| 6 months - 5 years, Week 42 | 0 | 1 | 0 |
| 6 months - 5 years, Week 43 | 0 | 0 | 0 |
| 6 months - 5 years, Week 44 | 0 | 0 | 0 |
| 6 months - 5 years, Week 45 | 0 | 0 | 0 |
| 6 months - 5 years, Week 46 | 0 | 0 | 0 |
| 6 months - 5 years, Week 47 | 1 | 0 | 0 |
| 6 months - 5 years, Week 48 | 0 | 0 | 0 |
| 6-12 years, Week 37 | 0 | 0 | 0 |
| 6-12 years, Week 38 | 0 | 0 | 0 |
| 6-12 years, Week 39 | 0 | 0 | 0 |
| 6-12 years, Week 40 | 0 | 0 | 0 |
| 6-12 years, Week 41 | 0 | 0 | 0 |
| 6-12 years, Week 42 | 0 | 0 | 0 |
| 6-12 years, Week 43 | 0 | 1 | 0 |
| 6-12 years, Week 44 | 0 | 0 | 0 |
| 6-12 years, Week 45 | 0 | 0 | 0 |
| 6-12 years, Week 46 | 0 | 0 | 1 |
| 6-12 years, Week 47 | 0 | 0 | 1 |
| 6-12 years, Week 48 | 0 | 0 | 0 |
| 13-17 years, Week 37 | 0 | 0 | 0 |
| 13-17 years, Week 38 | 0 | 0 | 0 |
| 13-17 years, Week 39 | 0 | 0 | 0 |
| 13-17 years, Week 40 | 0 | 0 | 0 |
| 13-17 years, Week 41 | 0 | 0 | 0 |
| 13-17 years, Week 42 | 0 | 0 | 0 |
| 13-17 years, Week 43 | 0 | 0 | 0 |
| 13-17 years, Week 44 | 0 | 0 | 0 |
| 13-17 years, Week 45 | 0 | 0 | 0 |
| 13-17 years, Week 46 | 0 | 0 | 0 |
| 13-17 years, Week 47 | 0 | 0 | 0 |
| 13-17 years, Week 48 | 0 | 0 | 0 |
| 18-65 years, Week 37 | 0 | 0 | 0 |
| 18-65 years, Week 38 | 0 | 0 | 0 |
| 18-65 years, Week 39 | 2 | 0 | 0 |
| 18-65 years, Week 40 | 4 | 1 | 0 |
| 18-65 years, Week 41 | 2 | 0 | 0 |
| 18-65 years, Week 42 | 2 | 0 | 0 |
| 18-65 years, Week 43 | 2 | 0 | 0 |
| 18-65 years, Week 44 | 1 | 0 | 0 |
| 18-65 years, Week 45 | 1 | 0 | 0 |
| 18-65 years, Week 46 | 2 | 0 | 0 |
| 18-65 years, Week 47 | 0 | 0 | 0 |
| 18-65 years, Week 48 | 0 | 0 | 0 |
| >65 years, Week 37 | 0 | 0 | 0 |
| >65 years, Week 38 | 2 | 0 | 0 |
| >65 years, Week 39 | 8 | 0 | 0 |
| >65 years, Week 40 | 3 | 0 | 0 |
| >65 years, Week 41 | 5 | 0 | 0 |
| >65 years, Week 42 | 5 | 0 | 0 |
| >65 years, Week 43 | 2 | 0 | 0 |
| >65 years, Week 44 | 2 | 0 | 0 |
| >65 years, Week 45 | 1 | 0 | 0 |
| >65 years, Week 46 | 2 | 0 | 0 |
| >65 years, Week 47 | 2 | 0 | 0 |
| >65 years, Week 48 | 0 | 0 | 0 |
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| 6 months - 5 years, Week 37 | 0 | 0 | 0 |
| 6 months - 5 years, Week 38 | 0 | 0 | 0 |
| 6 months - 5 years, Week 39 | 0 | 0 | 0 |
| 6 months - 5 years, Week 40 | 0 | 2 | 0 |
| 6 months - 5 years, Week 41 | 0 | 2 | 0 |
| 6 months - 5 years, Week 42 | 0 | 3 | 0 |
| 6 months - 5 years, Week 43 | 0 | 3 | 0 |
| 6 months - 5 years, Week 44 | 0 | 3 | 0 |
| 6 months - 5 years, Week 45 | 0 | 3 | 0 |
| 6 months - 5 years, Week 46 | 0 | 3 | 0 |
| 6 months - 5 years, Week 47 | 1 | 3 | 0 |
| 6 months - 5 years, Week 48 | 1 | 3 | 0 |
| 6-12 years, Week 37 | 0 | 0 | 0 |
| 6-12 years, Week 38 | 0 | 0 | 0 |
| 6-12 years, Week 39 | 0 | 0 | 0 |
| 6-12 years, Week 40 | 0 | 0 | 0 |
| 6-12 years, Week 41 | 0 | 0 | 0 |
| 6-12 years, Week 42 | 0 | 0 | 0 |
| 6-12 years, Week 43 | 0 | 1 | 0 |
| 6-12 years, Week 44 | 0 | 1 | 0 |
| 6-12 years, Week 45 | 0 | 1 | 0 |
| 6-12 years, Week 46 | 0 | 1 | 1 |
| 6-12 years, Week 47 | 0 | 1 | 2 |
| 6-12 years, Week 48 | 0 | 1 | 2 |
| 13-17 years, Week 37 | 0 | 0 | 0 |
| 13-17 years, Week 38 | 0 | 0 | 0 |
| 13-17 years, Week 39 | 0 | 0 | 0 |
| 13-17 years, Week 40 | 0 | 0 | 0 |
| 13-17 years, Week 41 | 0 | 0 | 0 |
| 13-17 years, Week 42 | 0 | 0 | 0 |
| 13-17 years, Week 43 | 0 | 0 | 0 |
| 13-17 years, Week 44 | 0 | 0 | 0 |
| 13-17 years, Week 45 | 0 | 0 | 0 |
| 13-17 years, Week 46 | 0 | 0 | 0 |
| 13-17 years, Week 47 | 0 | 0 | 0 |
| 13-17 years, Week 48 | 0 | 0 | 0 |
| 18-65 years, Week 37 | 0 | 0 | 0 |
| 18-65 years, Week 38 | 0 | 0 | 0 |
| 18-65 years, Week 39 | 2 | 0 | 0 |
| 18-65 years, Week 40 | 6 | 1 | 0 |
| 18-65 years, Week 41 | 8 | 1 | 0 |
| 18-65 years, Week 42 | 10 | 1 | 0 |
| 18-65 years, Week 43 | 12 | 1 | 0 |
| 18-65 years, Week 44 | 13 | 1 | 0 |
| 18-65 years, Week 45 | 14 | 1 | 0 |
| 18-65 years, Week 46 | 16 | 1 | 0 |
| 18-65 years, Week 47 | 16 | 1 | 0 |
| 18-65 years, Week 48 | 16 | 1 | 0 |
| >65 years, Week 37 | 0 | 0 | 0 |
| >65 years, Week 38 | 2 | 0 | 0 |
| >65 years, Week 39 | 10 | 0 | 0 |
| >65 years, Week 40 | 13 | 6 | 0 |
| >65 years, Week 41 | 18 | 0 | 0 |
| >65 years, Week 42 | 21 | 1 | 0 |
| >65 years, Week 43 | 23 | 1 | 0 |
| >65 years, Week 44 | 25 | 1 | 0 |
| >65 years, Week 45 | 26 | 1 | 0 |
| >65 years, Week 46 | 28 | 1 | 0 |
| >65 years, Week 47 | 30 | 1 | 0 |
| >65 years, Week 48 | 30 | 1 | 0 |
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| 6 months - 5 years, Week 37 | 0 | 0 | 0 |
| 6 months - 5 years, Week 38 | 0 | 0 | 0 |
| 6 months - 5 years, Week 39 | 0 | 0 | 0 |
| 6 months - 5 years, Week 40 | 0 | 0 | 0 |
| 6 months - 5 years, Week 41 | 0 | 0 | 0 |
| 6 months - 5 years, Week 42 | 0 | 0 | 0 |
| 6 months - 5 years, Week 43 | 0 | 0 | 0 |
| 6 months - 5 years, Week 44 | 0 | 0 | 0 |
| 6 months - 5 years, Week 45 | 0 | 0 | 0 |
| 6 months - 5 years, Week 46 | 0 | 0 | 0 |
| 6 months - 5 years, Week 47 | 0 | 0 | 0 |
| 6 months - 5 years, Week 48 | 0 | 0 | 0 |
| 6-12 years, Week 37 | 0 | 0 | 0 |
| 6-12 years, Week 38 | 0 | 0 | 0 |
| 6-12 years, Week 39 | 0 | 0 | 0 |
| 6-12 years, Week 40 | 0 | 0 | 0 |
| 6-12 years, Week 41 | 0 | 0 | 0 |
| 6-12 years, Week 42 | 0 | 0 | 0 |
| 6-12 years, Week 43 | 0 | 0 | 0 |
| 6-12 years, Week 44 | 0 | 0 | 0 |
| 6-12 years, Week 45 | 0 | 0 | 0 |
| 6-12 years, Week 46 | 0 | 0 | 0 |
| 6-12 years, Week 47 | 0 | 0 | 0 |
| 6-12 years, Week 48 | 0 | 0 | 0 |
| 13-17 years, Week 37 | 0 | 0 | 0 |
| 13-17 years, Week 38 | 0 | 0 | 0 |
| 13-17 years, Week 39 | 0 | 0 | 0 |
| 13-17 years, Week 40 | 0 | 0 | 0 |
| 13-17 years, Week 41 | 0 | 0 | 0 |
| 13-17 years, Week 42 | 0 | 0 | 0 |
| 13-17 years, Week 43 | 0 | 0 | 0 |
| 13-17 years, Week 44 | 0 | 0 | 0 |
| 13-17 years, Week 45 | 0 | 0 | 0 |
| 13-17 years, Week 46 | 0 | 1 | 0 |
| 13-17 years, Week 47 | 0 | 0 | 0 |
| 13-17 years, Week 48 | 0 | 0 | 0 |
| 18-65 years, Week 37 | 0 | 0 | 0 |
| 18-65 years, Week 38 | 13 | 1 | 2 |
| 18-65 years, Week 39 | 19 | 1 | 1 |
| 18-65 years, Week 40 | 25 | 1 | 0 |
| 18-65 years, Week 41 | 15 | 1 | 0 |
| 18-65 years, Week 42 | 23 | 0 | 1 |
| 18-65 years, Week 43 | 5 | 0 | 0 |
| 18-65 years, Week 44 | 5 | 0 | 0 |
| 18-65 years, Week 45 | 9 | 0 | 0 |
| 18-65 years, Week 46 | 6 | 0 | 0 |
| 18-65 years, Week 47 | 1 | 0 | 1 |
| 18-65 years, Week 48 | 2 | 0 | 0 |
| >65 years, Week 37 | 0 | 0 | 0 |
| >65 years, Week 38 | 19 | 0 | 2 |
| >65 years, Week 39 | 52 | 1 | 2 |
| >65 years, Week 40 | 50 | 0 | 3 |
| >65 years, Week 41 | 33 | 0 | 0 |
| >65 years, Week 42 | 23 | 0 | 1 |
| >65 years, Week 43 | 3 | 1 | 0 |
| >65 years, Week 44 | 10 | 0 | 0 |
| >65 years, Week 45 | 9 | 0 | 2 |
| >65 years, Week 46 | 6 | 0 | 0 |
| >65 years, Week 47 | 1 | 0 | 0 |
| >65 years, Week 48 | 2 | 0 | 0 |
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| 6 months - 5 years, Week 37 | 0 | 0 | 0 |
| 6 months - 5 years, Week 38 | 0 | 0 | 0 |
| 6 months - 5 years, Week 39 | 0 | 0 | 0 |
| 6 months - 5 years, Week 40 | 0 | 0 | 0 |
| 6 months - 5 years, Week 41 | 0 | 0 | 0 |
| 6 months - 5 years, Week 42 | 0 | 0 | 0 |
| 6 months - 5 years, Week 43 | 0 | 0 | 0 |
| 6 months - 5 years, Week 44 | 0 | 0 | 0 |
| 6 months - 5 years, Week 45 | 0 | 0 | 0 |
| 6 months - 5 years, Week 46 | 0 | 0 | 0 |
| 6 months - 5 years, Week 47 | 0 | 0 | 0 |
| 6 months - 5 years, Week 48 | 0 | 0 | 0 |
| 6-12 years, Week 37 | 0 | 0 | 0 |
| 6-12 years, Week 38 | 0 | 0 | 0 |
| 6-12 years, Week 39 | 0 | 0 | 0 |
| 6-12 years, Week 40 | 0 | 0 | 0 |
| 6-12 years, Week 41 | 0 | 0 | 0 |
| 6-12 years, Week 42 | 0 | 0 | 0 |
| 6-12 years, Week 43 | 0 | 0 | 0 |
| 6-12 years, Week 44 | 0 | 0 | 0 |
| 6-12 years, Week 45 | 0 | 0 | 0 |
| 6-12 years, Week 46 | 0 | 0 | 0 |
| 6-12 years, Week 47 | 0 | 0 | 0 |
| 6-12 years, Week 48 | 0 | 0 | 0 |
| 13-17 years, Week 37 | 0 | 0 | 0 |
| 13-17 years, Week 38 | 0 | 0 | 0 |
| 13-17 years, Week 39 | 0 | 0 | 0 |
| 13-17 years, Week 40 | 0 | 0 | 0 |
| 13-17 years, Week 41 | 0 | 0 | 0 |
| 13-17 years, Week 42 | 0 | 0 | 0 |
| 13-17 years, Week 43 | 0 | 0 | 0 |
| 13-17 years, Week 44 | 0 | 0 | 0 |
| 13-17 years, Week 45 | 0 | 0 | 0 |
| 13-17 years, Week 46 | 0 | 1 | 0 |
| 13-17 years, Week 47 | 0 | 1 | 0 |
| 13-17 years, Week 48 | 0 | 1 | 0 |
| 18-65 years, Week 37 | 0 | 0 | 0 |
| 18-65 years, Week 38 | 13 | 1 | 2 |
| 18-65 years, Week 39 | 32 | 2 | 3 |
| 18-65 years, Week 40 | 57 | 3 | 3 |
| 18-65 years, Week 41 | 72 | 4 | 3 |
| 18-65 years, Week 42 | 95 | 4 | 4 |
| 18-65 years, Week 43 | 100 | 4 | 4 |
| 18-65 years, Week 44 | 105 | 4 | 4 |
| 18-65 years, Week 45 | 114 | 4 | 4 |
| 18-65 years, Week 46 | 120 | 4 | 4 |
| 18-65 years, Week 47 | 121 | 4 | 5 |
| 18-65 years, Week 48 | 123 | 4 | 5 |
| >65 years, Week 37 | 0 | 0 | 0 |
| >65 years, Week 38 | 19 | 0 | 2 |
| >65 years, Week 39 | 71 | 1 | 4 |
| >65 years, Week 40 | 121 | 1 | 7 |
| >65 years, Week 41 | 154 | 1 | 7 |
| >65 years, Week 42 | 177 | 1 | 8 |
| >65 years, Week 43 | 180 | 2 | 8 |
| >65 years, Week 44 | 190 | 2 | 8 |
| >65 years, Week 45 | 199 | 2 | 10 |
| >65 years, Week 46 | 205 | 2 | 10 |
| >65 years, Week 47 | 206 | 2 | 10 |
| >65 years, Week 48 | 208 | 2 | 10 |
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| 6 months - 5 years, Week 37 | 0 | 0 | 0 |
| 6 months - 5 years, Week 38 | 0 | 0 | 0 |
| 6 months - 5 years, Week 39 | 0 | 0 | 0 |
| 6 months - 5 years, Week 40 | 0 | 0 | 0 |
| 6 months - 5 years, Week 41 | 0 | 0 | 0 |
| 6 months - 5 years, Week 42 | 0 | 1 | 0 |
| 6 months - 5 years, Week 43 | 0 | 0 | 0 |
| 6 months - 5 years, Week 44 | 0 | 1 | 0 |
| 6 months - 5 years, Week 45 | 0 | 0 | 0 |
| 6 months - 5 years, Week 46 | 0 | 0 | 0 |
| 6 months - 5 years, Week 47 | 0 | 0 | 0 |
| 6 months - 5 years, Week 48 | 0 | 0 | 0 |
| 6-12 years, Week 37 | 0 | 0 | 0 |
| 6-12 years, Week 38 | 0 | 0 | 0 |
| 6-12 years, Week 39 | 0 | 0 | 0 |
| 6-12 years, Week 40 | 0 | 0 | 0 |
| 6-12 years, Week 41 | 0 | 0 | 1 |
| 6-12 years, Week 42 | 0 | 0 | 0 |
| 6-12 years, Week 43 | 1 | 0 | 0 |
| 6-12 years, Week 44 | 0 | 0 | 0 |
| 6-12 years, Week 45 | 0 | 0 | 0 |
| 6-12 years, Week 46 | 0 | 0 | 0 |
| 6-12 years, Week 47 | 0 | 0 | 0 |
| 6-12 years, Week 48 | 0 | 0 | 0 |
| 13-17 years, Week 37 | 0 | 0 | 0 |
| 13-17 years, Week 38 | 0 | 0 | 0 |
| 13-17 years, Week 39 | 0 | 0 | 0 |
| 13-17 years, Week 40 | 0 | 0 | 0 |
| 13-17 years, Week 41 | 0 | 0 | 0 |
| 13-17 years, Week 42 | 0 | 0 | 0 |
| 13-17 years, Week 43 | 0 | 0 | 0 |
| 13-17 years, Week 44 | 0 | 0 | 0 |
| 13-17 years, Week 45 | 0 | 0 | 0 |
| 13-17 years, Week 46 | 0 | 0 | 0 |
| 13-17 years, Week 47 | 0 | 0 | 0 |
| 13-17 years, Week 48 | 0 | 0 | 0 |
| 18-65 years, Week 37 | 0 | 0 | 0 |
| 18-65 years, Week 38 | 12 | 0 | 0 |
| 18-65 years, Week 39 | 22 | 1 | 0 |
| 18-65 years, Week 40 | 20 | 1 | 0 |
| 18-65 years, Week 41 | 13 | 0 | 2 |
| 18-65 years, Week 42 | 9 | 0 | 0 |
| 18-65 years, Week 43 | 8 | 1 | 2 |
| 18-65 years, Week 44 | 2 | 0 | 0 |
| 18-65 years, Week 45 | 9 | 0 | 0 |
| 18-65 years, Week 46 | 1 | 1 | 0 |
| 18-65 years, Week 47 | 1 | 0 | 0 |
| 18-65 years, Week 48 | 1 | 0 | 0 |
| >65 years, Week 37 | 0 | 0 | 0 |
| >65 years, Week 38 | 10 | 0 | 0 |
| >65 years, Week 39 | 30 | 0 | 0 |
| >65 years, Week 40 | 26 | 0 | 0 |
| >65 years, Week 41 | 18 | 0 | 0 |
| >65 years, Week 42 | 8 | 0 | 0 |
| >65 years, Week 43 | 4 | 0 | 0 |
| >65 years, Week 44 | 5 | 0 | 0 |
| >65 years, Week 45 | 4 | 0 | 0 |
| >65 years, Week 46 | 2 | 0 | 0 |
| >65 years, Week 47 | 0 | 0 | 0 |
| >65 years, Week 48 | 0 | 0 | 0 |
The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| 6 months - 5 years, Week 37 | 0 | 0 | 0 |
| 6 months - 5 years, Week 38 | 0 | 0 | 0 |
| 6 months - 5 years, Week 39 | 0 | 0 | 0 |
| 6 months - 5 years, Week 40 | 0 | 0 | 0 |
| 6 months - 5 years, Week 41 | 0 | 0 | 0 |
| 6 months - 5 years, Week 42 | 0 | 1 | 0 |
| 6 months - 5 years, Week 43 | 0 | 1 | 0 |
| 6 months - 5 years, Week 44 | 0 | 2 | 0 |
| 6 months - 5 years, Week 45 | 0 | 2 | 0 |
| 6 months - 5 years, Week 46 | 0 | 2 | 0 |
| 6 months - 5 years, Week 47 | 0 | 2 | 0 |
| 6 months - 5 years, Week 48 | 0 | 2 | 2 |
| 6-12 years, Week 37 | 0 | 0 | 0 |
| 6-12 years, Week 38 | 0 | 0 | 0 |
| 6-12 years, Week 39 | 0 | 0 | 0 |
| 6-12 years, Week 40 | 0 | 0 | 0 |
| 6-12 years, Week 41 | 0 | 0 | 1 |
| 6-12 years, Week 42 | 0 | 0 | 1 |
| 6-12 years, Week 43 | 1 | 0 | 1 |
| 6-12 years, Week 44 | 1 | 1 | 1 |
| 6-12 years, Week 45 | 1 | 0 | 1 |
| 6-12 years, Week 46 | 1 | 0 | 1 |
| 6-12 years, Week 47 | 1 | 0 | 1 |
| 6-12 years, Week 48 | 1 | 0 | 1 |
| 13-17 years, Week 37 | 0 | 0 | 0 |
| 13-17 years, Week 38 | 0 | 0 | 0 |
| 13-17 years, Week 39 | 0 | 0 | 0 |
| 13-17 years, Week 40 | 0 | 0 | 0 |
| 13-17 years, Week 41 | 0 | 0 | 0 |
| 13-17 years, Week 42 | 0 | 0 | 0 |
| 13-17 years, Week 43 | 0 | 0 | 0 |
| 13-17 years, Week 44 | 0 | 0 | 0 |
| 13-17 years, Week 45 | 0 | 0 | 0 |
| 13-17 years, Week 46 | 0 | 0 | 0 |
| 13-17 years, Week 47 | 0 | 0 | 0 |
| 13-17 years, Week 48 | 0 | 0 | 0 |
| 18-65 years, Week 37 | 0 | 0 | 0 |
| 18-65 years, Week 38 | 12 | 0 | 0 |
| 18-65 years, Week 39 | 34 | 1 | 0 |
| 18-65 years, Week 40 | 54 | 2 | 0 |
| 18-65 years, Week 41 | 67 | 2 | 2 |
| 18-65 years, Week 42 | 76 | 2 | 2 |
| 18-65 years, Week 43 | 84 | 3 | 4 |
| 18-65 years, Week 44 | 86 | 3 | 4 |
| 18-65 years, Week 45 | 95 | 3 | 4 |
| 18-65 years, Week 46 | 96 | 4 | 4 |
| 18-65 years, Week 47 | 97 | 4 | 4 |
| 18-65 years, Week 48 | 98 | 4 | 4 |
| >65 years, Week 37 | 0 | 0 | 0 |
| >65 years, Week 38 | 10 | 0 | 0 |
| >65 years, Week 39 | 40 | 0 | 0 |
| >65 years, Week 40 | 66 | 0 | 0 |
| >65 years, Week 41 | 84 | 0 | 0 |
| >65 years, Week 42 | 92 | 0 | 0 |
| >65 years, Week 43 | 96 | 0 | 0 |
| >65 years, Week 44 | 101 | 0 | 0 |
| >65 years, Week 45 | 105 | 0 | 0 |
| >65 years, Week 46 | 107 | 0 | 0 |
| >65 years, Week 47 | 107 | 0 | 0 |
| >65 years, Week 48 | 107 | 0 | 0 |
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| At risk, Week 37 | 0 | 0 | 0 |
| At risk, Week 38 | 81 | 4 | 7 |
| At risk, Week 39 | 216 | 8 | 2 |
| At risk, Week 40 | 203 | 10 | 4 |
| At risk, Week 41 | 155 | 4 | 6 |
| At risk, Week 42 | 105 | 7 | 7 |
| At risk, Week 43 | 49 | 4 | 9 |
| At risk, Week 44 | 47 | 4 | 3 |
| At risk, Week 45 | 49 | 1 | 3 |
| At risk, Week 46 | 29 | 5 | 2 |
| At risk, Week 47 | 11 | 2 | 3 |
| At risk, Week 48 | 11 | 1 | 1 |
| Not at risk, Week 37 | 0 | 0 | 0 |
| Not at risk, Week 38 | 6 | 0 | 0 |
| Not at risk, Week 39 | 11 | 2 | 1 |
| Not at risk, Week 40 | 15 | 1 | 0 |
| Not at risk, Week 41 | 17 | 1 | 1 |
| Not at risk, Week 42 | 13 | 3 | 1 |
| Not at risk, Week 43 | 8 | 0 | 1 |
| Not at risk, Week 44 | 5 | 2 | 1 |
| Not at risk, Week 45 | 5 | 1 | 1 |
| Not at risk, Week 46 | 8 | 1 | 0 |
| Not at risk, Week 47 | 3 | 0 | 0 |
| Not at risk, Week 48 | 2 | 1 | 1 |
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| At risk, Week 37 | 0 | 0 | 0 |
| At risk, Week 38 | 81 | 4 | 7 |
| At risk, Week 39 | 297 | 12 | 9 |
| At risk, Week 40 | 500 | 22 | 13 |
| At risk, Week 41 | 655 | 26 | 19 |
| At risk, Week 42 | 760 | 33 | 26 |
| At risk, Week 43 | 809 | 37 | 35 |
| At risk, Week 44 | 856 | 41 | 38 |
| At risk, Week 45 | 905 | 42 | 41 |
| At risk, Week 46 | 934 | 47 | 43 |
| At risk, Week 47 | 945 | 49 | 46 |
| At risk, Week 48 | 956 | 50 | 47 |
| Not at risk, Week 37 | 0 | 0 | 0 |
| Not at risk, Week 38 | 6 | 0 | 0 |
| Not at risk, Week 39 | 17 | 2 | 1 |
| Not at risk, Week 40 | 32 | 3 | 1 |
| Not at risk, Week 41 | 49 | 4 | 2 |
| Not at risk, Week 42 | 62 | 7 | 3 |
| Not at risk, Week 43 | 70 | 7 | 4 |
| Not at risk, Week 44 | 75 | 9 | 5 |
| Not at risk, Week 45 | 80 | 10 | 6 |
| Not at risk, Week 46 | 88 | 11 | 6 |
| Not at risk, Week 47 | 91 | 11 | 6 |
| Not at risk, Week 48 | 93 | 12 | 7 |
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| At risk, Week 37 | 0 | 0 | 0 |
| At risk, Week 38 | 8 | 2 | 2 |
| At risk, Week 39 | 23 | 3 | 0 |
| At risk, Week 40 | 21 | 5 | 0 |
| At risk, Week 41 | 18 | 2 | 1 |
| At risk, Week 42 | 13 | 2 | 1 |
| At risk, Week 43 | 11 | 0 | 3 |
| At risk, Week 44 | 6 | 2 | 2 |
| At risk, Week 45 | 7 | 1 | 1 |
| At risk, Week 46 | 9 | 1 | 0 |
| At risk, Week 47 | 1 | 0 | 1 |
| At risk, Week 48 | 4 | 0 | 1 |
| Not at risk, Week 37 | 0 | 0 | 0 |
| Not at risk, Week 38 | 0 | 0 | 0 |
| Not at risk, Week 39 | 0 | 2 | 0 |
| Not at risk, Week 40 | 1 | 0 | 0 |
| Not at risk, Week 41 | 2 | 1 | 0 |
| Not at risk, Week 42 | 2 | 2 | 1 |
| Not at risk, Week 43 | 2 | 0 | 0 |
| Not at risk, Week 44 | 0 | 0 | 1 |
| Not at risk, Week 45 | 1 | 1 | 1 |
| Not at risk, Week 46 | 2 | 0 | 0 |
| Not at risk, Week 47 | 1 | 0 | 0 |
| Not at risk, Week 48 | 1 | 1 | 1 |
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| At risk, Week 37 | 0 | 0 | 0 |
| At risk, Week 38 | 8 | 2 | 2 |
| At risk, Week 39 | 31 | 5 | 2 |
| At risk, Week 40 | 52 | 10 | 2 |
| At risk, Week 41 | 70 | 12 | 3 |
| At risk, Week 42 | 83 | 14 | 4 |
| At risk, Week 43 | 94 | 14 | 7 |
| At risk, Week 44 | 100 | 16 | 9 |
| At risk, Week 45 | 107 | 17 | 10 |
| At risk, Week 46 | 116 | 18 | 10 |
| At risk, Week 47 | 117 | 18 | 11 |
| At risk, Week 48 | 121 | 18 | 12 |
| Not at risk, Week 37 | 0 | 0 | 0 |
| Not at risk, Week 38 | 0 | 0 | 0 |
| Not at risk, Week 39 | 0 | 2 | 0 |
| Not at risk, Week 40 | 1 | 2 | 0 |
| Not at risk, Week 41 | 3 | 3 | 0 |
| Not at risk, Week 42 | 5 | 5 | 1 |
| Not at risk, Week 43 | 7 | 5 | 1 |
| Not at risk, Week 44 | 7 | 5 | 2 |
| Not at risk, Week 45 | 8 | 6 | 3 |
| Not at risk, Week 46 | 10 | 6 | 3 |
| Not at risk, Week 47 | 11 | 6 | 3 |
| Not at risk, Week 48 | 12 | 7 | 4 |
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| At risk, Week 37 | 0 | 0 | 0 |
| At risk, Week 38 | 14 | 0 | 0 |
| At risk, Week 39 | 19 | 0 | 0 |
| At risk, Week 40 | 21 | 0 | 0 |
| At risk, Week 41 | 26 | 0 | 0 |
| At risk, Week 42 | 13 | 0 | 0 |
| At risk, Week 43 | 6 | 0 | 0 |
| At risk, Week 44 | 5 | 0 | 0 |
| At risk, Week 45 | 8 | 0 | 0 |
| At risk, Week 46 | 2 | 0 | 0 |
| At risk, Week 47 | 0 | 0 | 0 |
| At risk, Week 48 | 0 | 0 | 0 |
| Not at risk, Week 37 | 0 | 0 | 0 |
| Not at risk, Week 38 | 2 | 0 | 0 |
| Not at risk, Week 39 | 1 | 0 | 1 |
| Not at risk, Week 40 | 3 | 0 | 3 |
| Not at risk, Week 41 | 2 | 0 | 0 |
| Not at risk, Week 42 | 2 | 0 | 0 |
| Not at risk, Week 43 | 0 | 0 | 0 |
| Not at risk, Week 44 | 2 | 0 | 0 |
| Not at risk, Week 45 | 0 | 0 | 0 |
| Not at risk, Week 46 | 1 | 0 | 0 |
| Not at risk, Week 47 | 0 | 0 | 0 |
| Not at risk, Week 48 | 0 | 0 | 0 |
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| At risk, Week 37 | 0 | 0 | 0 |
| At risk, Week 38 | 14 | 0 | 0 |
| At risk, Week 39 | 33 | 0 | 0 |
| At risk, Week 40 | 54 | 0 | 0 |
| At risk, Week 41 | 80 | 0 | 0 |
| At risk, Week 42 | 93 | 0 | 0 |
| At risk, Week 43 | 99 | 0 | 0 |
| At risk, Week 44 | 104 | 0 | 0 |
| At risk, Week 45 | 112 | 0 | 0 |
| At risk, Week 46 | 114 | 0 | 0 |
| At risk, Week 47 | 114 | 0 | 0 |
| At risk, Week 48 | 114 | 0 | 0 |
| Not at risk, Week 37 | 0 | 0 | 0 |
| Not at risk, Week 38 | 2 | 0 | 0 |
| Not at risk, Week 39 | 3 | 0 | 0 |
| Not at risk, Week 40 | 6 | 0 | 0 |
| Not at risk, Week 41 | 8 | 0 | 0 |
| Not at risk, Week 42 | 10 | 0 | 0 |
| Not at risk, Week 43 | 10 | 0 | 0 |
| Not at risk, Week 44 | 12 | 0 | 0 |
| Not at risk, Week 45 | 12 | 0 | 0 |
| Not at risk, Week 46 | 13 | 0 | 0 |
| Not at risk, Week 47 | 13 | 0 | 0 |
| Not at risk, Week 48 | 13 | 0 | 0 |
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| At risk, Week 37 | 0 | 0 | 0 |
| At risk, Week 38 | 19 | 0 | 0 |
| At risk, Week 39 | 46 | 1 | 0 |
| At risk, Week 40 | 46 | 0 | 0 |
| At risk, Week 41 | 26 | 0 | 0 |
| At risk, Week 42 | 20 | 0 | 1 |
| At risk, Week 43 | 4 | 0 | 0 |
| At risk, Week 44 | 7 | 0 | 0 |
| At risk, Week 45 | 8 | 0 | 0 |
| At risk, Week 46 | 5 | 0 | 0 |
| At risk, Week 47 | 2 | 0 | 0 |
| At risk, Week 48 | 0 | 0 | 0 |
| Not at risk, Week 37 | 0 | 0 | 0 |
| Not at risk, Week 38 | 2 | 0 | 0 |
| Not at risk, Week 39 | 5 | 0 | 0 |
| Not at risk, Week 40 | 2 | 0 | 0 |
| Not at risk, Week 41 | 2 | 0 | 0 |
| Not at risk, Week 42 | 2 | 0 | 0 |
| Not at risk, Week 43 | 1 | 0 | 0 |
| Not at risk, Week 44 | 0 | 0 | 0 |
| Not at risk, Week 45 | 2 | 0 | 0 |
| Not at risk, Week 46 | 2 | 0 | 0 |
| Not at risk, Week 47 | 0 | 0 | 0 |
| Not at risk, Week 48 | 1 | 0 | 0 |
AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| At risk, Week 37 | 0 | 0 | 0 |
| At risk, Week 38 | 19 | 0 | 0 |
| At risk, Week 39 | 65 | 1 | 0 |
| At risk, Week 40 | 111 | 1 | 0 |
| At risk, Week 41 | 137 | 1 | 0 |
| At risk, Week 42 | 157 | 1 | 1 |
| At risk, Week 43 | 161 | 1 | 1 |
| At risk, Week 44 | 168 | 1 | 1 |
| At risk, Week 45 | 176 | 1 | 1 |
| At risk, Week 46 | 181 | 1 | 1 |
| At risk, Week 47 | 183 | 1 | 1 |
| At risk, Week 48 | 183 | 1 | 1 |
| Not at risk, Week 37 | 0 | 0 | 0 |
| Not at risk, Week 38 | 2 | 0 | 0 |
| Not at risk, Week 39 | 7 | 0 | 0 |
| Not at risk, Week 40 | 9 | 0 | 0 |
| Not at risk, Week 41 | 11 | 0 | 0 |
| Not at risk, Week 42 | 13 | 0 | 0 |
| Not at risk, Week 43 | 14 | 0 | 0 |
| Not at risk, Week 44 | 14 | 0 | 0 |
| Not at risk, Week 45 | 16 | 0 | 0 |
| Not at risk, Week 46 | 18 | 0 | 0 |
| Not at risk, Week 47 | 18 | 0 | 0 |
| Not at risk, Week 48 | 19 | 0 | 0 |
Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| At risk, Week 37 | 0 | 0 | 0 |
| At risk, Week 38 | 32 | 1 | 1 |
| At risk, Week 39 | 114 | 2 | 0 |
| At risk, Week 40 | 103 | 2 | 1 |
| At risk, Week 41 | 77 | 2 | 2 |
| At risk, Week 42 | 56 | 3 | 3 |
| At risk, Week 43 | 27 | 1 | 4 |
| At risk, Week 44 | 18 | 3 | 1 |
| At risk, Week 45 | 26 | 0 | 0 |
| At risk, Week 46 | 12 | 2 | 0 |
| At risk, Week 47 | 5 | 2 | 0 |
| At risk, Week 48 | 2 | 1 | 0 |
| Not at risk, Week 37 | 0 | 0 | 0 |
| Not at risk, Week 38 | 2 | 0 | 0 |
| Not at risk, Week 39 | 6 | 1 | 0 |
| Not at risk, Week 40 | 8 | 0 | 0 |
| Not at risk, Week 41 | 5 | 0 | 0 |
| Not at risk, Week 42 | 9 | 1 | 0 |
| Not at risk, Week 43 | 2 | 0 | 1 |
| Not at risk, Week 44 | 2 | 1 | 0 |
| Not at risk, Week 45 | 3 | 0 | 0 |
| Not at risk, Week 46 | 2 | 1 | 0 |
| Not at risk, Week 47 | 2 | 0 | 0 |
| Not at risk, Week 48 | 0 | 0 | 0 |
Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| At risk, Week 37 | 0 | 0 | 0 |
| At risk, Week 38 | 32 | 1 | 1 |
| At risk, Week 39 | 146 | 3 | 1 |
| At risk, Week 40 | 249 | 5 | 2 |
| At risk, Week 41 | 326 | 7 | 4 |
| At risk, Week 42 | 382 | 10 | 7 |
| At risk, Week 43 | 409 | 11 | 11 |
| At risk, Week 44 | 427 | 14 | 12 |
| At risk, Week 45 | 453 | 14 | 12 |
| At risk, Week 46 | 465 | 16 | 12 |
| At risk, Week 47 | 470 | 18 | 12 |
| At risk, Week 48 | 472 | 19 | 12 |
| Not at risk, Week 37 | 0 | 0 | 0 |
| Not at risk, Week 38 | 2 | 0 | 0 |
| Not at risk, Week 39 | 8 | 1 | 0 |
| Not at risk, Week 40 | 16 | 1 | 0 |
| Not at risk, Week 41 | 21 | 1 | 0 |
| Not at risk, Week 42 | 30 | 2 | 0 |
| Not at risk, Week 43 | 32 | 2 | 1 |
| Not at risk, Week 44 | 34 | 3 | 1 |
| Not at risk, Week 45 | 37 | 3 | 1 |
| Not at risk, Week 46 | 39 | 4 | 1 |
| Not at risk, Week 47 | 41 | 4 | 1 |
| Not at risk, Week 48 | 41 | 4 | 1 |
Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| At risk, Week 37 | 0 | 0 | 0 |
| At risk, Week 38 | 16 | 0 | 0 |
| At risk, Week 39 | 30 | 0 | 0 |
| At risk, Week 40 | 33 | 0 | 1 |
| At risk, Week 41 | 22 | 0 | 1 |
| At risk, Week 42 | 18 | 1 | 0 |
| At risk, Week 43 | 7 | 0 | 0 |
| At risk, Week 44 | 5 | 0 | 0 |
| At risk, Week 45 | 6 | 0 | 0 |
| At risk, Week 46 | 4 | 0 | 1 |
| At risk, Week 47 | 1 | 0 | 0 |
| At risk, Week 48 | 0 | 0 | 0 |
| Not at risk, Week 37 | 0 | 0 | 0 |
| Not at risk, Week 38 | 2 | 0 | 0 |
| Not at risk, Week 39 | 2 | 0 | 0 |
| Not at risk, Week 40 | 1 | 0 | 0 |
| Not at risk, Week 41 | 3 | 0 | 0 |
| Not at risk, Week 42 | 1 | 1 | 0 |
| Not at risk, Week 43 | 2 | 0 | 0 |
| Not at risk, Week 44 | 0 | 0 | 0 |
| Not at risk, Week 45 | 0 | 0 | 0 |
| Not at risk, Week 46 | 0 | 0 | 0 |
| Not at risk, Week 47 | 0 | 0 | 0 |
| Not at risk, Week 48 | 1 | 0 | 0 |
Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| At risk, Week 37 | 0 | 0 | 0 |
| At risk, Week 38 | 16 | 0 | 0 |
| At risk, Week 39 | 46 | 0 | 0 |
| At risk, Week 40 | 79 | 0 | 1 |
| At risk, Week 41 | 101 | 0 | 2 |
| At risk, Week 42 | 119 | 1 | 2 |
| At risk, Week 43 | 126 | 1 | 2 |
| At risk, Week 44 | 131 | 1 | 2 |
| At risk, Week 45 | 137 | 1 | 2 |
| At risk, Week 46 | 141 | 1 | 3 |
| At risk, Week 47 | 142 | 1 | 3 |
| At risk, Week 48 | 142 | 1 | 3 |
| Not at risk, Week 37 | 0 | 0 | 0 |
| Not at risk, Week 38 | 2 | 0 | 0 |
| Not at risk, Week 39 | 4 | 0 | 0 |
| Not at risk, Week 40 | 5 | 0 | 0 |
| Not at risk, Week 41 | 8 | 0 | 0 |
| Not at risk, Week 42 | 9 | 1 | 0 |
| Not at risk, Week 43 | 11 | 1 | 0 |
| Not at risk, Week 44 | 11 | 1 | 0 |
| Not at risk, Week 45 | 11 | 1 | 0 |
| Not at risk, Week 46 | 11 | 1 | 0 |
| Not at risk, Week 47 | 11 | 1 | 0 |
| Not at risk, Week 48 | 12 | 1 | 0 |
Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| At risk, Week 37 | 0 | 0 | 0 |
| At risk, Week 38 | 1 | 1 | 0 |
| At risk, Week 39 | 2 | 0 | 0 |
| At risk, Week 40 | 3 | 0 | 0 |
| At risk, Week 41 | 0 | 0 | 0 |
| At risk, Week 42 | 1 | 0 | 0 |
| At risk, Week 43 | 2 | 0 | 0 |
| At risk, Week 44 | 1 | 0 | 0 |
| At risk, Week 45 | 1 | 0 | 0 |
| At risk, Week 46 | 0 | 0 | 0 |
| At risk, Week 47 | 0 | 0 | 0 |
| At risk, Week 48 | 1 | 0 | 0 |
| Not at risk, Week 37 | 0 | 0 | 0 |
| Not at risk, Week 38 | 0 | 0 | 0 |
| Not at risk, Week 39 | 0 | 0 | 0 |
| Not at risk, Week 40 | 0 | 0 | 0 |
| Not at risk, Week 41 | 0 | 0 | 0 |
| Not at risk, Week 42 | 2 | 0 | 0 |
| Not at risk, Week 43 | 0 | 0 | 0 |
| Not at risk, Week 44 | 0 | 0 | 0 |
| Not at risk, Week 45 | 0 | 0 | 0 |
| Not at risk, Week 46 | 1 | 0 | 0 |
| Not at risk, Week 47 | 0 | 0 | 0 |
| Not at risk, Week 48 | 0 | 0 | 0 |
Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| At risk, Week 37 | 0 | 0 | 0 |
| At risk, Week 38 | 1 | 1 | 0 |
| At risk, Week 39 | 3 | 1 | 0 |
| At risk, Week 40 | 6 | 1 | 0 |
| At risk, Week 41 | 6 | 1 | 0 |
| At risk, Week 42 | 7 | 1 | 0 |
| At risk, Week 43 | 9 | 1 | 0 |
| At risk, Week 44 | 10 | 1 | 0 |
| At risk, Week 45 | 11 | 1 | 0 |
| At risk, Week 46 | 11 | 1 | 0 |
| At risk, Week 47 | 11 | 1 | 0 |
| At risk, Week 48 | 12 | 1 | 0 |
| Not at risk, Week 37 | 0 | 0 | 0 |
| Not at risk, Week 38 | 0 | 0 | 0 |
| Not at risk, Week 39 | 0 | 0 | 0 |
| Not at risk, Week 40 | 0 | 0 | 0 |
| Not at risk, Week 41 | 0 | 0 | 0 |
| Not at risk, Week 42 | 2 | 0 | 0 |
| Not at risk, Week 43 | 2 | 0 | 0 |
| Not at risk, Week 44 | 2 | 0 | 0 |
| Not at risk, Week 45 | 2 | 0 | 0 |
| Not at risk, Week 46 | 3 | 0 | 0 |
| Not at risk, Week 47 | 3 | 0 | 0 |
| Not at risk, Week 48 | 3 | 0 | 0 |
Rash AEs include any rash AEs, generalised rash and rash.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| At risk, Week 37 | 0 | 0 | 0 |
| At risk, Week 38 | 2 | 0 | 0 |
| At risk, Week 39 | 10 | 0 | 0 |
| At risk, Week 40 | 7 | 2 | 0 |
| At risk, Week 41 | 7 | 0 | 0 |
| At risk, Week 42 | 4 | 2 | 0 |
| At risk, Week 43 | 4 | 1 | 0 |
| At risk, Week 44 | 3 | 0 | 0 |
| At risk, Week 45 | 2 | 0 | 0 |
| At risk, Week 46 | 3 | 0 | 1 |
| At risk, Week 47 | 3 | 0 | 1 |
| At risk, Week 48 | 0 | 0 | 0 |
| Not at risk, Week 37 | 0 | 0 | 0 |
| Not at risk, Week 38 | 0 | 0 | 0 |
| Not at risk, Week 39 | 0 | 0 | 0 |
| Not at risk, Week 40 | 0 | 1 | 0 |
| Not at risk, Week 41 | 0 | 0 | 0 |
| Not at risk, Week 42 | 1 | 0 | 0 |
| Not at risk, Week 43 | 0 | 0 | 0 |
| Not at risk, Week 44 | 0 | 0 | 0 |
| Not at risk, Week 45 | 0 | 0 | 0 |
| Not at risk, Week 46 | 1 | 0 | 0 |
| Not at risk, Week 47 | 0 | 0 | 0 |
| Not at risk, Week 48 | 0 | 0 | 0 |
Rash AEs include any rash AEs, generalised rash and rash.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| At risk, Week 37 | 0 | 0 | 0 |
| At risk, Week 38 | 2 | 0 | 0 |
| At risk, Week 39 | 12 | 0 | 0 |
| At risk, Week 40 | 19 | 2 | 0 |
| At risk, Week 41 | 26 | 2 | 0 |
| At risk, Week 42 | 30 | 4 | 0 |
| At risk, Week 43 | 34 | 5 | 0 |
| At risk, Week 44 | 37 | 5 | 0 |
| At risk, Week 45 | 39 | 5 | 0 |
| At risk, Week 46 | 42 | 5 | 1 |
| At risk, Week 47 | 45 | 5 | 2 |
| At risk, Week 48 | 45 | 5 | 2 |
| Not at risk, Week 37 | 0 | 0 | 0 |
| Not at risk, Week 38 | 0 | 0 | 0 |
| Not at risk, Week 39 | 0 | 0 | 0 |
| Not at risk, Week 40 | 0 | 1 | 0 |
| Not at risk, Week 41 | 0 | 1 | 0 |
| Not at risk, Week 42 | 1 | 1 | 0 |
| Not at risk, Week 43 | 1 | 1 | 0 |
| Not at risk, Week 44 | 1 | 1 | 0 |
| Not at risk, Week 45 | 1 | 1 | 0 |
| Not at risk, Week 46 | 2 | 1 | 0 |
| Not at risk, Week 47 | 2 | 1 | 0 |
| Not at risk, Week 48 | 2 | 1 | 0 |
Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| At risk, Week 37 | 0 | 0 | 0 |
| At risk, Week 38 | 29 | 1 | 4 |
| At risk, Week 39 | 64 | 2 | 2 |
| At risk, Week 40 | 72 | 1 | 3 |
| At risk, Week 41 | 43 | 1 | 0 |
| At risk, Week 42 | 44 | 0 | 2 |
| At risk, Week 43 | 8 | 1 | 0 |
| At risk, Week 44 | 15 | 0 | 0 |
| At risk, Week 45 | 15 | 0 | 2 |
| At risk, Week 46 | 9 | 1 | 0 |
| At risk, Week 47 | 1 | 0 | 1 |
| At risk, Week 48 | 4 | 0 | 0 |
| Not at risk, Week 37 | 0 | 0 | 0 |
| Not at risk, Week 38 | 3 | 0 | 0 |
| Not at risk, Week 39 | 7 | 0 | 1 |
| Not at risk, Week 40 | 3 | 0 | 0 |
| Not at risk, Week 41 | 5 | 0 | 0 |
| Not at risk, Week 42 | 2 | 0 | 0 |
| Not at risk, Week 43 | 0 | 0 | 0 |
| Not at risk, Week 44 | 0 | 0 | 0 |
| Not at risk, Week 45 | 3 | 0 | 0 |
| Not at risk, Week 46 | 3 | 0 | 0 |
| Not at risk, Week 47 | 1 | 0 | 0 |
| Not at risk, Week 48 | 0 | 0 | 0 |
Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| At risk, Week 37 | 0 | 0 | 0 |
| At risk, Week 38 | 29 | 1 | 4 |
| At risk, Week 39 | 93 | 3 | 6 |
| At risk, Week 40 | 165 | 4 | 9 |
| At risk, Week 41 | 208 | 5 | 9 |
| At risk, Week 42 | 252 | 5 | 11 |
| At risk, Week 43 | 260 | 6 | 11 |
| At risk, Week 44 | 275 | 6 | 11 |
| At risk, Week 45 | 290 | 6 | 13 |
| At risk, Week 46 | 299 | 7 | 13 |
| At risk, Week 47 | 300 | 7 | 14 |
| At risk, Week 48 | 304 | 7 | 14 |
| Not at risk, Week 37 | 0 | 0 | 0 |
| Not at risk, Week 38 | 3 | 0 | 0 |
| Not at risk, Week 39 | 10 | 0 | 1 |
| Not at risk, Week 40 | 13 | 0 | 1 |
| Not at risk, Week 41 | 18 | 0 | 1 |
| Not at risk, Week 42 | 20 | 0 | 1 |
| Not at risk, Week 43 | 20 | 0 | 1 |
| Not at risk, Week 44 | 20 | 0 | 1 |
| Not at risk, Week 45 | 23 | 0 | 1 |
| Not at risk, Week 46 | 26 | 0 | 1 |
| Not at risk, Week 47 | 27 | 0 | 1 |
| Not at risk, Week 48 | 27 | 0 | 1 |
Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| At risk, Week 37 | 0 | 0 | 0 |
| At risk, Week 38 | 19 | 0 | 0 |
| At risk, Week 39 | 48 | 1 | 0 |
| At risk, Week 40 | 40 | 1 | 0 |
| At risk, Week 41 | 30 | 0 | 2 |
| At risk, Week 42 | 15 | 0 | 0 |
| At risk, Week 43 | 11 | 1 | 2 |
| At risk, Week 44 | 6 | 0 | 0 |
| At risk, Week 45 | 11 | 0 | 0 |
| At risk, Week 46 | 3 | 1 | 0 |
| At risk, Week 47 | 0 | 0 | 0 |
| At risk, Week 48 | 0 | 0 | 0 |
| Not at risk, Week 37 | 0 | 0 | 0 |
| Not at risk, Week 38 | 3 | 0 | 0 |
| Not at risk, Week 39 | 4 | 0 | 0 |
| Not at risk, Week 40 | 6 | 0 | 0 |
| Not at risk, Week 41 | 1 | 0 | 1 |
| Not at risk, Week 42 | 2 | 1 | 0 |
| Not at risk, Week 43 | 2 | 0 | 0 |
| Not at risk, Week 44 | 1 | 1 | 0 |
| Not at risk, Week 45 | 2 | 0 | 0 |
| Not at risk, Week 46 | 0 | 0 | 0 |
| Not at risk, Week 47 | 1 | 0 | 0 |
| Not at risk, Week 48 | 1 | 0 | 0 |
Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions.
| Participants | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| At risk, Week 37 | 0 | 0 | 0 |
| At risk, Week 38 | 19 | 0 | 0 |
| At risk, Week 39 | 67 | 1 | 0 |
| At risk, Week 40 | 107 | 2 | 0 |
| At risk, Week 41 | 137 | 2 | 2 |
| At risk, Week 42 | 152 | 2 | 2 |
| At risk, Week 43 | 163 | 3 | 4 |
| At risk, Week 44 | 169 | 3 | 4 |
| At risk, Week 45 | 180 | 3 | 4 |
| At risk, Week 46 | 183 | 4 | 4 |
| At risk, Week 47 | 183 | 4 | 4 |
| At risk, Week 48 | 183 | 4 | 4 |
| Not at risk, Week 37 | 0 | 0 | 0 |
| Not at risk, Week 38 | 3 | 0 | 0 |
| Not at risk, Week 39 | 7 | 0 | 0 |
| Not at risk, Week 40 | 13 | 0 | 0 |
| Not at risk, Week 41 | 14 | 0 | 1 |
| Not at risk, Week 42 | 16 | 1 | 1 |
| Not at risk, Week 43 | 18 | 1 | 1 |
| Not at risk, Week 44 | 19 | 2 | 1 |
| Not at risk, Week 45 | 21 | 2 | 1 |
| Not at risk, Week 46 | 21 | 2 | 1 |
| Not at risk, Week 47 | 22 | 2 | 1 |
| Not at risk, Week 48 | 23 | 2 | 1 |
Collected over Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | — | 0/13,861 (0%) | 1,049/13,861 (7.6%) |
| Vaccinated_Non GSK Group | — | 0/2,295 (0%) | 62/2,295 (2.7%) |
| Vaccinated_Unknown Group | — | 0/3,178 (0%) | 54/3,178 (1.7%) |
| Event | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| Muscle aches/myalgiaMusculoskeletal and connective tissue disorders | 311/13861 | 7/2295 | 15/3178 |
| Nasal congestionGeneral disorders | 276/13861 | 3/2295 | 0/3178 |
| RhinorrhoeaGeneral disorders | 243/13861 | 2/2295 | 0/3178 |
| CoughGeneral disorders | 210/13861 | 17/2295 | 13/3178 |
| HeadacheGeneral disorders | 192/13861 | 6/2295 | 5/3178 |
| FatigueGeneral disorders | 169/13861 | 0/2295 | 1/3178 |
| Oropharyngeal painGeneral disorders | 155/13861 | 2/2295 | 0/3178 |
| Fever/pyrexiaGeneral disorders | 133/13861 | 25/2295 | 16/3178 |
| Local erythemaGeneral disorders | 127/13861 | 0/2295 | 0/3178 |
| CoryzaGeneral disorders | 96/13861 | 0/2295 | 0/3178 |
| Age, Continuous(Years) | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group | Total |
|---|---|---|---|---|
| Mean | 66 ± 16.2 | 24 ± 29.7 | 57 ± 24.9 | 60 ± 24.1 |
| Sex: Female, Male(Participants) | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group | Total |
|---|---|---|---|---|
| Female | 7661 | 1159 | 1808 | 10628 |
| Male | 6200 | 1136 | 1370 | 8706 |
| Race/Ethnicity, Customized(Participants) | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group | Total |
|---|---|---|---|---|
| Asian | 327 | 244 | 123 | 694 |
| Black | 275 | 334 | 133 | 742 |
| White | 9581 | 906 | 1506 | 11993 |
| Mixed | 39 | 64 | 10 | 113 |
| Other | 36 | 19 | 5 | 60 |
| Missing | 3603 | 728 | 1401 | 5732 |
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