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CompletedNCT03932682Updated Mar 4, 2025Results posted

Efficacy Study With QIVc in Pediatric Subjects

A Phase 3 interventional study of QIVc and Comparator in Influenza, Human, sponsored by Seqirus. Completed at 74 sites in 15 countries. Open to participants aged 6 Months to 47 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-04.

Sponsored by Seqirus (part of CSL Limited) · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
5,723
Allocation
Randomized
Ages
6 Months to 47 Months
Sex
All
01

Study summary

This phase 3 clinical study is a randomized, observer-blind, multicenter study of QIVc versus a non-influenza vaccine in subjects 6 months though 47 months of age. The purpose of this study is to evaluate efficacy of QIVc in the prevention of laboratory confirmed influenza A or B disease in children 6 through 47 months of age, compared to a non-influenza vaccine.

02

Conditions studied

  • Influenza, Human

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Keywords

  • Influenza Vaccine
03

In context

Influenza, Human

2,356 studies on the registry are indexed under Influenza, Human; 184 are open to participants now.

This study's enrollment of 5,723 is above the median of 227 across 1,957 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Seqirus is the lead sponsor of 53 studies on the registry; none are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 10 (67%) have results posted.

First submitted after Seqirus became part of CSL Limited.

Browse Seqirus studies →All CSL Limited studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 47 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Inclusion criteria

In order to participate in this study, all subjects must meet all of the inclusion criteria described.

  • Individuals of 6 through 47 months of age on the day of .
  • Individuals whose parent(s)/Legally Acceptable Representative (LAR) have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
  • Individuals who can comply with study procedures including follow-up.
  • Individuals in generally good health as per the Investigator's medical judgement.

If applicable, prior to receipt of second study vaccination, subjects must be evaluated to confirm that they are eligible for subsequent vaccination. If subjects do not meet the criteria of the original inclusion criteria listed above, they should not receive additional vaccinations.

Exclusion criteria

Exclusion Criteria:

  • Acute (severe) febrile illness. Enrollment could be considered if the fever is absent for 72 hours.
  • History of any anaphylaxis, serious vaccine reactions or , including allergic reactions, to any component of vaccine or medical equipment whose use is foreseen in this study.
  • Clinical conditions representing a to intramuscular vaccination and blood draws. These may include known bleeding disorders, or treatment with anticoagulants in the 3 weeks preceding vaccination.
  • A known history of Guillain-Barré Syndrome or other demyelinating diseases such as encephalomyelitis and transverse myelitis.
  • Abnormal function of the immune system resulting from a clinical condition
  • Received influenza vaccination or has had documented influenza disease in the last 6 months prior to .
  • Prior vaccination to prevent Neisseria meningitides serogroup C disease or prior infection caused by this organism.

Additional eligibility criteria are provided in the study protocol.

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
5,723 participants (actual)

Study arms

  • Experimental
    QIVc

    Cell-derived Quadrivalent Influenza Vaccine

    Biological: QIVc

  • Active comparator
    Comparator

    Non-influenza Comparator

    Biological: Comparator

Interventions

  • BiologicalQIVc

    QIVc is a quadrivalent vaccine and contains 2 influenza type A strains and 2 influenza type B lineages recommended by World Health Organization (WHO) for inclusion in the quadrivalent vaccine formulation for the influenza season corresponding to the season of conduct of study.

    Also known as: Flucelvax Quadrivalent

  • BiologicalComparator

    Meningococcal Group C Polysaccharide Conjugate Vaccine (NeisVac-C)

06

What researchers measure

Primary outcomes

  1. Efficacy Endpoint: First Occurrence of Reverse Transcription-polymerase Chain Reaction (RT-PCR) Confirmed Influenza, Due to Any Influenza Type A and/or B Virus Regardless of Antigenic Match

    First occurrence of RT-PCR confirmed influenza, due to any influenza Type A and/or B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at \>14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined influenza-like illness (ILI) symptoms

    Time frame: >14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects)

  2. Efficacy Endpoint: First Occurrence of Culture Confirmed Influenza, Due to Influenza Type A and/or B Virus Antigenically Matched by Ferret Antigenicity Testing to the Strains Selected for the Seasonal Influenza Vaccine

    First occurrence of culture confirmed influenza, due to influenza Type A and/or B virus antigenically matched by ferret antigenicity testing to the strains selected for the seasonal influenza vaccine, occurring at \>14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined ILI symptoms

    Time frame: >14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects)

Secondary outcomes

  1. Efficacy Endpoint: First Occurrence of Culture Confirmed Influenza Caused by Influenza Virus Strains Antigenically Dissimilar to the Influenza Strains Selected for the Seasonal Influenza Vaccine

    First occurrence of culture confirmed influenza caused by influenza virus strains antigenically dissimilar to the influenza strains selected for the seasonal vaccine occurring at \>14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined ILI symptoms

    Time frame: >14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects)

  2. Efficacy Endpoint: First Occurrence of Culture Confirmed Influenza Due to Any Influenza Type A and/or Type B Virus Regardless of Antigenic Match to the Influenza Strains Selected for the Seasonal Influenza Vaccine

    First occurrence of culture confirmed influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at \>14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined ILI symptoms

    Time frame: >14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects)

  3. Efficacy Endpoint: First Occurrence of RT-PCR Confirmed Moderate-to-severe Influenza Due to Any Influenza Type A and/or Type B Virus Regardless of Antigenic Match to the Influenza Strains Selected for the Seasonal Influenza Vaccine

    First occurrence of RT-PCR confirmed moderate-to-severe influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at \>14 days after the last vaccination and until the end of the influenza season

    Time frame: >14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects)

  4. Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay)

    The measures for immunogenicity are determined by a hemagglutination inhibition (HI) assay prior to first vaccination and 28 days after last vaccination for all four influenza strains HI = hemagglutination inhibition Adjusted GMTs are presented

    Time frame: Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects

  5. Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay)

    The measures for immunogenicity are determined by a HI assay prior to first vaccination and 28 days after last vaccination for all four influenza strains SCR is defined as the percentage of subjects with either a prevaccination HI titer \<1:10 and a postvaccination HI titer ≥1:40, or a prevaccination HI titer ≥1:10 and a ≥4-fold increase in postvaccination HI titer

    Time frame: Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects

  6. Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay)

    The measures for immunogenicity are determined by a hemagglutination inhibition (HI) assay prior to first vaccination and 28 days after last vaccination for all four influenza strains GMR is the geometric mean of the fold increase of postvaccination HI titer over the prevaccination HI titer Adjusted GMRs are presented

    Time frame: Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects

  7. Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay)

    The measures for immunogenicity are determined by a microneutralization (MN) assay prior to first vaccination and 28 days after last vaccination for all four influenza strains

    Time frame: Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects

  8. Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay)

    The measures for immunogenicity are determined by a MN assay prior to first vaccination and 28 days after last vaccination for all four influenza strains SCR is defined as the percentage of subjects with either a prevaccination MN titer \<1:10 and a postvaccination MN titer ≥1:40, or a prevaccination MN titer ≥1:10 and a ≥4-fold increase in postvaccination MN titer

    Time frame: Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects

  9. Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay)

    The measures for immunogenicity are determined by a MN assay prior to first vaccination and 28 days after last vaccination for all four influenza strains GMR is the geometric mean of the fold increase of post-vaccination MN titer over the pre-vaccination MN titer

    Time frame: Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects

  10. Safety Endpoint: Percentage of Subjects With Solicited Local and Systemic Adverse Events (AEs)

    Percentage of subjects with solicited local and systemic AEs assessed for 7 days following each vaccination in the QIVc group and in the comparator group

    Time frame: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects

  11. Safety Endpoint: Percentage of Subjects With Unsolicited AEs

    Percentage of subjects with any unsolicited AEs assessed in the QIVc group and in the comparator group until 28 days after each vaccination

    Time frame: 28 days after each vaccination in the treatment period, ie, Day 1 to Day 29 for previously vaccinated subjects and Day 1 to Day 57 for not previously vaccinated subjects

  12. Safety Endpoint: Percentage of Subjects With SAEs, NOCDs, AEs Leading to Withdrawal From the Study or Vaccination

    Percentage of subjects with serious adverse events (SAEs), new onset of chronic disease (NOCD), AEs leading to withdrawal from the study or vaccination, and all medications associated with these events in the QIVc group and in the comparator group Note: The time frame for assessment of these AEs was Day 1 through Study Completion as indicated below. Subjects aged 6 months through 11 months at enrollment in countries without NeisVac-C vaccine marketing authorization had an additional study visit 28 days later (ie, Day 237).

    Time frame: Day 1 through Study Completion, ie, Day 1 to Day 181 or end of influenza season, whichever was longer, for previously vaccinated subjects and Day 1 to Day 209 or end of influenza season, whichever was longer, for not previously vaccinated subjects

  13. Safety Endpoint: Percentage of Subjects With Medically-attended AEs

    Percentage of subjects with medically-attended AEs within 30 days after ILI onset in the QIVc group and in the comparator group

    Time frame: If a subject experienced an ILI during approximately 8 months of study participation, medically-attended AEs were collected for the 30-day period after onset of the ILI (defined as the first day that a subject meets the criteria for protocol-defined ILI)

07

Results

Posted Mar 4, 2025

Participant flow

Participant flow — Overall Study
MilestoneQIVcComparator
Started28602863
Completed27942766
Not completed6697
Withdrew: Death12
Withdrew: Withdrawal by subject3745
Withdrew: Lost to follow-up1925
Withdrew: Protocol violation02
Withdrew: Other923

Outcome measures

PrimaryEfficacy Endpoint: First Occurrence of Reverse Transcription-polymerase Chain Reaction (RT-PCR) Confirmed Influenza, Due to Any Influenza Type A and/or B Virus Regardless of Antigenic Match

First occurrence of RT-PCR confirmed influenza, due to any influenza Type A and/or B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at \>14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined influenza-like illness (ILI) symptoms

Time frame:
>14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects)
Reported as:
Number · Cases
Efficacy Endpoint: First Occurrence of Reverse Transcription-polymerase Chain Reaction (RT-PCR) Confirmed Influenza, Due to Any Influenza Type A and/or B Virus Regardless of Antigenic Match
CasesQIVcComparator
Efficacy Endpoint: First Occurrence of Reverse Transcription-polymerase Chain Reaction (RT-PCR) Confirmed Influenza, Due to Any Influenza Type A and/or B Virus Regardless of Antigenic Match104173
Statistical analysis
  • QIVc vs Comparator · Cox proportional hazard: 41.26 · 97.98% CI 21.55 to 56.02
PrimaryEfficacy Endpoint: First Occurrence of Culture Confirmed Influenza, Due to Influenza Type A and/or B Virus Antigenically Matched by Ferret Antigenicity Testing to the Strains Selected for the Seasonal Influenza Vaccine

First occurrence of culture confirmed influenza, due to influenza Type A and/or B virus antigenically matched by ferret antigenicity testing to the strains selected for the seasonal influenza vaccine, occurring at \>14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined ILI symptoms

Time frame:
>14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects)
Reported as:
Number · Cases
Efficacy Endpoint: First Occurrence of Culture Confirmed Influenza, Due to Influenza Type A and/or B Virus Antigenically Matched by Ferret Antigenicity Testing to the Strains Selected for the Seasonal Influenza Vaccine
CasesQIVcComparator
Efficacy Endpoint: First Occurrence of Culture Confirmed Influenza, Due to Influenza Type A and/or B Virus Antigenically Matched by Ferret Antigenicity Testing to the Strains Selected for the Seasonal Influenza Vaccine4482
Statistical analysis
  • QIVc vs Comparator · Cox proportional hazard: 46.90 · 97.5% CI 19.19 to 65.11
SecondaryEfficacy Endpoint: First Occurrence of Culture Confirmed Influenza Caused by Influenza Virus Strains Antigenically Dissimilar to the Influenza Strains Selected for the Seasonal Influenza Vaccine

First occurrence of culture confirmed influenza caused by influenza virus strains antigenically dissimilar to the influenza strains selected for the seasonal vaccine occurring at \>14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined ILI symptoms

Time frame:
>14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects)
Reported as:
Number · Cases
Efficacy Endpoint: First Occurrence of Culture Confirmed Influenza Caused by Influenza Virus Strains Antigenically Dissimilar to the Influenza Strains Selected for the Seasonal Influenza Vaccine
CasesQIVcComparator
Efficacy Endpoint: First Occurrence of Culture Confirmed Influenza Caused by Influenza Virus Strains Antigenically Dissimilar to the Influenza Strains Selected for the Seasonal Influenza Vaccine2043
Statistical analysis
  • QIVc vs Comparator · Cox proportional hazard: 54.49 · 95% CI 22.55 to 73.26
SecondaryEfficacy Endpoint: First Occurrence of Culture Confirmed Influenza Due to Any Influenza Type A and/or Type B Virus Regardless of Antigenic Match to the Influenza Strains Selected for the Seasonal Influenza Vaccine

First occurrence of culture confirmed influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at \>14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined ILI symptoms

Time frame:
>14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects)
Reported as:
Number · Cases
Efficacy Endpoint: First Occurrence of Culture Confirmed Influenza Due to Any Influenza Type A and/or Type B Virus Regardless of Antigenic Match to the Influenza Strains Selected for the Seasonal Influenza Vaccine
CasesQIVcComparator
Efficacy Endpoint: First Occurrence of Culture Confirmed Influenza Due to Any Influenza Type A and/or Type B Virus Regardless of Antigenic Match to the Influenza Strains Selected for the Seasonal Influenza Vaccine61121
Statistical analysis
  • QIVc vs Comparator · Cox proportional hazard: 50.67 · 95% CI 32.83 to 63.77
SecondaryEfficacy Endpoint: First Occurrence of RT-PCR Confirmed Moderate-to-severe Influenza Due to Any Influenza Type A and/or Type B Virus Regardless of Antigenic Match to the Influenza Strains Selected for the Seasonal Influenza Vaccine

First occurrence of RT-PCR confirmed moderate-to-severe influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at \>14 days after the last vaccination and until the end of the influenza season

Time frame:
>14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects)
Reported as:
Number · Cases
Efficacy Endpoint: First Occurrence of RT-PCR Confirmed Moderate-to-severe Influenza Due to Any Influenza Type A and/or Type B Virus Regardless of Antigenic Match to the Influenza Strains Selected for the Seasonal Influenza Vaccine
CasesQIVcComparator
Efficacy Endpoint: First Occurrence of RT-PCR Confirmed Moderate-to-severe Influenza Due to Any Influenza Type A and/or Type B Virus Regardless of Antigenic Match to the Influenza Strains Selected for the Seasonal Influenza Vaccine09
Statistical analysis
  • QIVc vs Comparator · Cox proportional hazard: 100The 2-sided 95% confidence interval was calculated with a lower limit of "not estimable" and an upper limit of 100.
SecondaryImmunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay)

The measures for immunogenicity are determined by a hemagglutination inhibition (HI) assay prior to first vaccination and 28 days after last vaccination for all four influenza strains HI = hemagglutination inhibition Adjusted GMTs are presented

Time frame:
Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects
Reported as:
Geometric mean · Geometric mean titer
Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay)
Geometric mean titerQIVc (Season 1)Comparator (Season 1)QIVc (Season 2)Comparator (Season 2)QIVc (Season 3)Comparator (Season 3)QIVc (Season 4)Comparator (Season 4)QIVc (Season 5)Comparator (Season 5)
A/H1N1 Day 1 HI GMT40.06 (21.41 to 74.97)44.28 (24.19 to 81.07)22.99 (9.52 to 55.49)27.50 (11.60 to 65.18)10.15 (4.45 to 23.13)8.72 (3.87 to 19.60)57.83 (34.41 to 97.19)58.00 (34.81 to 96.64)13.60 (1.97 to 93.97)13.94 (1.95 to 99.61)
A/H1N1 Day 29/57 HI GMT126.39 (68.37 to 233.66)60.33 (33.32 to 109.21)60.77 (33.77 to 109.38)11.24 (6.32 to 20.02)49.38 (22.92 to 106.39)5.45 (2.56 to 11.58)149.01 (96.96 to 229.01)81.71 (53.55 to 124.68)362.71 (74.42 to 1767.89)60.84 (12.14 to 304.84)
A/H3N2 Day 1 HI GMTNA (NA to NA)NA (NA to NA)12.21 (5.59 to 26.70)14.14 (6.57 to 30.41)NA (NA to NA)NA (NA to NA)46.38 (21.09 to 101.98)35.62 (16.41 to 77.30)82.67 (19.98 to 342.16)120.80 (28.47 to 512.58)
A/H3N2 Day 29/57 HI GMTNA (NA to NA)NA (NA to NA)95.36 (43.91 to 207.07)8.79 (4.11 to 18.77)NA (NA to NA)NA (NA to NA)67.88 (36.64 to 125.77)38.85 (21.22 to 71.10)440.30 (127.04 to 1526.08)57.87 (16.29 to 205.63)
B/Yamagata Day 1 HI GMT11.66 (8.26 to 16.46)11.53 (8.27 to 16.09)9.87 (6.86 to 14.22)8.22 (5.75 to 11.75)7.65 (4.25 to 13.79)7.54 (4.19 to 13.57)8.96 (6.78 to 11.84)9.49 (7.22 to 12.48)7.30 (4.19 to 12.73)7.35 (4.18 to 12.95)
B/Yamagata Day 29/57 HI GMT18.94 (13.07 to 27.46)6.90 (4.82 to 9.87)23.65 (14.04 to 39.85)13.57 (8.17 to 22.53)13.85 (6.91 to 27.77)5.26 (2.63 to 10.53)13.80 (8.95 to 21.28)4.70 (3.06 to 7.22)53.72 (20.85 to 138.40)8.04 (3.07 to 21.06)
B/Victoria Day 1 HI GMT7.40 (5.35 to 10.24)8.36 (6.11 to 11.43)9.37 (7.46 to 11.76)9.31 (7.45 to 11.63)8.34 (5.40 to 12.90)9.39 (6.12 to 14.42)5.82 (5.18 to 6.53)6.08 (5.42 to 6.82)7.84 (1.38 to 44.61)5.92 (1.01 to 34.73)
B/Victoria Day 29/57 HI GMT14.97 (10.42 to 21.49)7.01 (4.94 to 9.95)16.84 (11.32 to 25.07)8.82 (5.97 to 13.02)9.54 (5.60 to 16.25)4.88 (2.89 to 8.26)23.92 (13.98 to 40.92)4.67 (2.73 to 7.97)539.53 (158.62 to 1835.19)45.34 (13.01 to 157.93)
SecondaryImmunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay)

The measures for immunogenicity are determined by a HI assay prior to first vaccination and 28 days after last vaccination for all four influenza strains SCR is defined as the percentage of subjects with either a prevaccination HI titer \<1:10 and a postvaccination HI titer ≥1:40, or a prevaccination HI titer ≥1:10 and a ≥4-fold increase in postvaccination HI titer

Time frame:
Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects
Reported as:
Number · Percentage of participants
Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay)
Percentage of participantsQIVc (Season 1)Comparator (Season 1)QIVc (Season 2)Comparator (Season 2)QIVc (Season 3)Comparator (Season 3)QIVc (Season 4)Comparator (Season 4)QIVc (Season 5)Comparator (Season 5)
A/H1N1 SCR HI Titer45.54 (36.10 to 55.22)12.04 (6.57 to 19.70)57.01 (47.08 to 66.54)3.60 (0.99 to 8.97)68.47 (58.96 to 76.96)2.68 (0.56 to 7.63)29.89 (20.54 to 40.65)4.71 (1.30 to 11.61)75.00 (65.75 to 82.83)12.96 (7.27 to 20.79)
A/H3N2 SCR HI TiterNA (NA to NA)NA (NA to NA)70.09 (60.48 to 78.56)6.31 (2.57 to 12.56)NA (NA to NA)NA (NA to NA)44.83 (34.15 to 55.87)28.24 (19.00 to 39.04)84.26 (76.00 to 90.55)15.74 (9.45 to 24.00)
B/Yamagata SCR HI Titer37.50 (28.53 to 47.15)3.70 (1.02 to 9.21)24.30 (16.53 to 33.54)6.31 (2.57 to 12.56)23.42 (15.91 to 32.41)0.90 (0.02 to 4.92)29.89 (20.54 to 40.65)1.18 (0.03 to 6.38)66.67 (56.95 to 75.45)3.70 (1.02 to 9.21)
B/Victoria SCR HI Titer24.11 (16.53 to 33.10)2.78 (0.58 to 7.90)13.08 (7.34 to 20.98)0.90 (0.02 to 4.92)9.91 (5.05 to 17.04)0.00 (NA to NA)42.53 (31.99 to 53.59)3.53 (0.73 to 9.97)80.56 (71.83 to 87.54)8.33 (3.88 to 15.23)
SecondaryImmunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay)

The measures for immunogenicity are determined by a hemagglutination inhibition (HI) assay prior to first vaccination and 28 days after last vaccination for all four influenza strains GMR is the geometric mean of the fold increase of postvaccination HI titer over the prevaccination HI titer Adjusted GMRs are presented

Time frame:
Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects
Reported as:
Geometric mean · Geometric mean ratio
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay)
Geometric mean ratioQIVc (Season 1)Comparator (Season 1)QIVc (Season 2)Comparator (Season 2)QIVc (Season 3)Comparator (Season 3)QIVc (Season 4)Comparator (Season 4)QIVc (Season 5)Comparator (Season 5)
A/H1N1 GMR HI Titer3.36 (1.69 to 6.66)1.53 (0.79 to 2.95)3.71 (2.04 to 6.73)0.67 (0.37 to 1.20)6.28 (2.91 to 13.56)0.70 (0.33 to 1.50)2.59 (1.51 to 4.45)1.42 (0.83 to 2.41)19.20 (3.61 to 102.12)3.20 (0.58 to 17.52)
A/H3N2 GMR HI TiterNA (NA to NA)NA (NA to NA)7.43 (2.95 to 18.75)0.62 (0.25 to 1.54)NA (NA to NA)NA (NA to NA)1.81 (0.86 to 3.81)1.19 (0.57 to 2.48)7.14 (1.81 to 28.16)0.80 (0.20 to 3.24)
B/Yamagata GMR HI Titer2.52 (1.75 to 3.63)0.92 (0.65 to 1.31)3.38 (2.02 to 5.67)1.96 (1.18 to 3.25)1.95 (0.91 to 4.15)0.75 (0.35 to 1.59)2.03 (1.32 to 3.13)0.68 (0.44 to 1.04)8.04 (3.12 to 20.72)1.20 (0.46 to 3.15)
B/Victoria GMR HI Titer2.01 (1.37 to 2.96)0.90 (0.62 to 1.30)1.79 (1.15 to 2.79)0.94 (0.61 to 1.46)1.43 (0.83 to 2.44)0.71 (0.42 to 1.21)4.44 (2.62 to 7.55)0.85 (0.51 to 1.43)32.55 (8.85 to 119.71)2.95 (0.78 to 11.09)
SecondaryImmunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay)

The measures for immunogenicity are determined by a microneutralization (MN) assay prior to first vaccination and 28 days after last vaccination for all four influenza strains

Time frame:
Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects
Reported as:
Geometric mean · Geometric mean titer
Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay)
Geometric mean titerQIVc (Season 1)Comparator (Season 1)QIVc (Season 2)Comparator (Season 2)QIVc (Season 3)Comparator (Season 3)QIVc (Season 4)Comparator (Season 4)QIVc (Season 5)Comparator (Season 5)
A/H1N1 Day 1 MN GMT22.06 (9.53 to 51.07)31.10 (13.83 to 69.92)57.54 (18.79 to 176.16)55.89 (18.69 to 167.19)61.40 (16.51 to 228.37)43.43 (11.93 to 158.11)32.15 (19.17 to 53.90)35.32 (21.25 to 58.71)113.94 (36.64 to 354.34)115.49 (36.41 to 366.35)
A/H1N1 Day 29/57 MN GMT329.08 (196.16 to 552.06)36.24 (21.97 to 59.79)473.15 (247.69 to 903.85)66.69 (35.39 to 125.71)459.87 (157.55 to 1342.31)19.32 (6.76 to 55.21)86.91 (58.51 to 129.11)46.51 (31.53 to 68.60)352.09 (110.01 to 1126.90)86.61 (26.51 to 282.92)
A/H3N2 Day 1 MN GMT6.92 (4.91 to 9.76)6.29 (4.51 to 8.76)4.96 (4.19 to 5.88)4.80 (4.07 to 5.67)7.02 (3.18 to 15.51)8.33 (3.82 to 18.16)17.70 (10.34 to 30.31)15.77 (9.29 to 26.76)26.08 (7.79 to 87.37)25.98 (7.59 to 88.87)
A/H3N2 Day 29/57 MN GMT27.55 (18.70 to 40.58)10.95 (7.52 to 15.94)12.04 (7.60 to 19.08)5.31 (3.38 to 8.34)57.93 (28.43 to 118.06)10.49 (5.21 to 21.09)35.99 (18.52 to 69.94)14.78 (7.70 to 28.34)139.97 (41.52 to 471.84)30.22 (8.78 to 104.08)
B/Yamagata Day 1 MN GMT76.91 (53.50 to 110.55)66.14 (46.60 to 93.87)65.25 (35.87 to 118.70)60.03 (33.41 to 107.86)15.33 (7.73 to 30.41)15.26 (7.78 to 29.93)53.41 (32.42 to 88.00)54.11 (33.12 to 88.41)51.81 (23.27 to 115.35)45.20 (20.02 to 102.06)
B/Yamagata Day 29/57 MN GMT278.89 (202.31 to 384.46)88.67 (65.06 to 120.84)283.42 (183.07 to 438.79)126.59 (82.43 to 194.41)55.17 (27.19 to 111.92)19.24 (9.59 to 38.59)84.60 (55.74 to 128.38)52.11 (34.57 to 78.55)169.24 (75.01 to 381.86)49.34 (21.58 to 112.85)
B/Victoria Day 1 MN GMT6.07 (4.82 to 7.65)6.64 (5.31 to 8.30)4.99 (4.16 to 5.99)5.18 (4.33 to 6.18)9.09 (4.80 to 17.24)10.71 (5.71 to 20.09)8.79 (6.40 to 12.07)7.72 (5.66 to 10.55)15.97 (2.53 to 100.98)12.20 (1.87 to 79.68)
B/Victoria Day 29/57 MN GMT14.23 (10.95 to 18.51)7.00 (5.44 to 9.02)5.29 (4.03 to 6.92)5.26 (4.04 to 6.85)26.81 (14.06 to 51.12)9.65 (5.12 to 18.20)121.02 (59.56 to 245.87)5.99 (2.99 to 11.97)938.65 (230.67 to 3819.51)39.32 (9.41 to 164.32)
SecondaryImmunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay)

The measures for immunogenicity are determined by a MN assay prior to first vaccination and 28 days after last vaccination for all four influenza strains SCR is defined as the percentage of subjects with either a prevaccination MN titer \<1:10 and a postvaccination MN titer ≥1:40, or a prevaccination MN titer ≥1:10 and a ≥4-fold increase in postvaccination MN titer

Time frame:
Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects
Reported as:
Number · Percentage of participants
Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay)
Percentage of participantsQIVc (Season 1)Comparator (Season 1)QIVc (Season 2)Comparator (Season 2)QIVc (Season 3)Comparator (Season 3)QIVc (Season 4)Comparator (Season 4)QIVc (Season 5)Comparator (Season 5)
A/H1N1 SCR (%) MN Titer73.21 (64.02 to 81.14)2.78 (0.58 to 7.90)74.77 (65.45 to 82.67)4.50 (1.48 to 10.20)87.39 (79.74 to 92.93)4.46 (1.47 to 10.11)32.18 (22.56 to 43.06)7.06 (2.63 to 14.73)68.52 (58.88 to 77.12)15.74 (9.45 to 24.00)
A/H3N2 SCR (%) MN Titer38.39 (29.36 to 48.06)4.63 (1.52 to 10.47)20.56 (13.36 to 29.46)1.80 (0.22 to 6.36)57.66 (47.92 to 66.98)1.79 (0.22 to 6.30)33.33 (23.58 to 44.25)10.59 (4.96 to 19.15)71.30 (61.80 to 79.59)15.74 (9.45 to 24.00)
B/Yamagata SCR (%) MN Titer46.43 (36.95 to 56.10)0.93 (0.02 to 5.05)30.84 (22.27 to 40.50)3.60 (0.99 to 8.97)36.94 (27.97 to 46.62)4.46 (1.47 to 10.11)19.54 (11.81 to 29.43)4.71 (1.30 to 11.61)54.63 (44.76 to 64.24)7.41 (3.25 to 14.07)
B/Victoria SCR (%) MN Titer20.54 (13.49 to 29.20)0.93 (0.02 to 5.05)0.93 (0.02 to 5.10)2.70 (0.56 to 7.70)25.23 (17.46 to 34.35)0.89 (0.02 to 4.87)87.36 (78.50 to 93.52)7.06 (2.63 to 14.73)94.44 (88.30 to 97.93)9.26 (4.53 to 16.37)
SecondaryImmunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay)

The measures for immunogenicity are determined by a MN assay prior to first vaccination and 28 days after last vaccination for all four influenza strains GMR is the geometric mean of the fold increase of post-vaccination MN titer over the pre-vaccination MN titer

Time frame:
Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects
Reported as:
Geometric mean · Geometric mean ratio
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay)
Geometric mean ratioQIVc (Season 1)Comparator (Season 1)QIVc (Season 2)Comparator (Season 2)QIVc (Season 3)Comparator (Season 3)QIVc (Season 4)Comparator (Season 4)QIVc (Season 5)Comparator (Season 5)
A/H1N1 GMR MN Titer16.16 (9.52 to 27.45)1.70 (1.02 to 2.83)8.12 (4.19 to 15.75)1.15 (0.60 to 2.20)17.55 (5.72 to 53.86)0.81 (0.27 to 2.44)2.37 (1.54 to 3.67)1.23 (0.80 to 1.88)3.47 (1.07 to 11.24)0.85 (0.26 to 2.81)
A/H3N2 GMR MN Titer3.28 (2.23 to 4.84)1.32 (0.91 to 1.92)2.14 (1.35 to 3.40)0.93 (0.59 to 1.46)5.92 (2.79 to 12.56)1.01 (0.48 to 2.13)2.74 (1.39 to 5.38)1.16 (0.60 to 2.26)4.40 (1.30 to 14.88)0.95 (0.27 to 3.28)
B/Yamagata GMR MN Titer3.93 (2.81 to 5.49)1.30 (0.94 to 1.79)3.05 (1.95 to 4.75)1.38 (0.89 to 2.13)3.15 (1.47 to 6.71)1.10 (0.52 to 2.32)1.82 (1.15 to 2.88)1.11 (0.71 to 1.75)3.81 (1.56 to 9.33)1.19 (0.48 to 2.95)
B/Victoria GMR MN Titer2.17 (1.67 to 2.82)1.07 (0.83 to 1.37)1.04 (0.77 to 1.40)1.01 (0.75 to 1.35)2.74 (1.37 to 5.47)0.92 (0.47 to 1.83)16.90 (8.36 to 34.19)0.86 (0.43 to 1.72)31.51 (7.19 to 138.05)1.42 (0.31 to 6.37)
SecondarySafety Endpoint: Percentage of Subjects With Solicited Local and Systemic Adverse Events (AEs)

Percentage of subjects with solicited local and systemic AEs assessed for 7 days following each vaccination in the QIVc group and in the comparator group

Time frame:
7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Reported as:
Number · Percentage of participants
Safety Endpoint: Percentage of Subjects With Solicited Local and Systemic Adverse Events (AEs)
Percentage of participantsQIVcComparator
Solicited AEs55.860.8
Solicited Local AEs32.340.4
Solicited Systemic AEs40.942.5
Analgesic/Antipyretic Use14.515.0
SecondarySafety Endpoint: Percentage of Subjects With Unsolicited AEs

Percentage of subjects with any unsolicited AEs assessed in the QIVc group and in the comparator group until 28 days after each vaccination

Time frame:
28 days after each vaccination in the treatment period, ie, Day 1 to Day 29 for previously vaccinated subjects and Day 1 to Day 57 for not previously vaccinated subjects
Reported as:
Number · Percentage of participants
Safety Endpoint: Percentage of Subjects With Unsolicited AEs
Percentage of participantsQIVcComparator
Any AE42.545.4
Any related AE4.23.6
SecondarySafety Endpoint: Percentage of Subjects With SAEs, NOCDs, AEs Leading to Withdrawal From the Study or Vaccination

Percentage of subjects with serious adverse events (SAEs), new onset of chronic disease (NOCD), AEs leading to withdrawal from the study or vaccination, and all medications associated with these events in the QIVc group and in the comparator group Note: The time frame for assessment of these AEs was Day 1 through Study Completion as indicated below. Subjects aged 6 months through 11 months at enrollment in countries without NeisVac-C vaccine marketing authorization had an additional study visit 28 days later (ie, Day 237).

Time frame:
Day 1 through Study Completion, ie, Day 1 to Day 181 or end of influenza season, whichever was longer, for previously vaccinated subjects and Day 1 to Day 209 or end of influenza season, whichever was longer, for not previously vaccinated subjects
Reported as:
Number · Percentage of participants
Safety Endpoint: Percentage of Subjects With SAEs, NOCDs, AEs Leading to Withdrawal From the Study or Vaccination
Percentage of participantsQIVcComparator
SAE2.23.0
Related SAE00.04
NOCD0.70.4
AE leading to study withdrawal00
AE leading to study vaccine withdrawal00.1
SecondarySafety Endpoint: Percentage of Subjects With Medically-attended AEs

Percentage of subjects with medically-attended AEs within 30 days after ILI onset in the QIVc group and in the comparator group

Time frame:
If a subject experienced an ILI during approximately 8 months of study participation, medically-attended AEs were collected for the 30-day period after onset of the ILI (defined as the first day that a subject meets the criteria for protocol-defined ILI)
Reported as:
Number · Percentage of participants
Safety Endpoint: Percentage of Subjects With Medically-attended AEs
Percentage of participantsQIVcComparator
Safety Endpoint: Percentage of Subjects With Medically-attended AEs28.932.6

Adverse events

Collected over Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
QIVc1/2,856 (0%)64/2,856 (2.2%)2,050/2,856 (71.8%)
Comparator2/2,841 (0.1%)84/2,841 (3%)2,126/2,841 (74.8%)
Most frequent serious events
Showing 10 of 64
Most frequent serious events
EventQIVcComparator
PneumoniaInfections and infestations15/285624/2841
GastroenteritisInfections and infestations8/285612/2841
Dengue feverInfections and infestations6/28567/2841
InfluenzaInfections and infestations3/28566/2841
Febrile convulsionNervous system disorders5/28563/2841
Viral infectionInfections and infestations4/28560/2841
BronchiolitisInfections and infestations2/28563/2841
BronchitisInfections and infestations1/28563/2841
TonsillitisInfections and infestations0/28563/2841
Respiratory syncytial virus bronchitisInfections and infestations2/28562/2841
Most frequent other events
Showing 10 of 14
Most frequent other events
EventQIVcComparator
Injection site painGeneral disorders816/2856889/2841
Injection site erythemaGeneral disorders717/2856884/2841
Injection site indurationGeneral disorders464/2856730/2841
IrritabilityPsychiatric disorders659/2856706/2841
Upper respiratory tract infectionInfections and infestations576/2856634/2841
SomnolenceNervous system disorders514/2856522/2841
Eating disorderPsychiatric disorders447/2856455/2841
DiarrhoeaGastrointestinal disorders372/2856372/2841
Injection site bruisingGeneral disorders303/2856339/2841
PyrexiaGeneral disorders307/2856307/2841

Baseline characteristics

Age, Continuous
Age, Continuous(months)QIVcComparatorTotal
Mean25.8 ± 11.925.9 ± 11.925.9 ± 11.9
Age, Customized
Age, Customized(Participants)QIVcComparatorTotal
6 months through 23 months126812642532
24 months through 47 months159215993191
Sex: Female, Male
Sex: Female, Male(Participants)QIVcComparatorTotal
Female141813332751
Male144215302972
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)QIVcComparatorTotal
Hispanic or Latino155157312
Not Hispanic or Latino269626975393
Unknown or Not Reported9918
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)QIVcComparatorTotal
American Indian or Alaska Native000
Asian109810962194
Black or African American348349697
Native Hawaiian or Other Pacific Islander011
White123912342473
Other175183358
Region of Enrollment
Region of Enrollment(Participants)QIVcComparatorTotal
Romania383371
Czechia413879
Philippines6086091217
Ukraine184183367
Malaysia313465
Thailand7269141
New Zealand7714
Bangladesh10199200
Latvia325
Pakistan279282561
Poland217220437
Honduras147151298
South Africa376380756
Bulgaria131135266
Estonia6256211246
Previous influenza vaccination
Previous influenza vaccination(Participants)QIVcComparatorTotal
Previously vaccinated4862110
Not previously vaccinated281228015613
Participants enrolled in each influenza season
Participants enrolled in each influenza season(Participants)QIVcComparatorTotal
Season 1344349693
Season 2497489986
Season 35255211046
Season 44965041000
Season 599810001998

1 further baseline measures are reported on the registry.

08

Study locations

74 sites
  • International Centre for Diarrhoeal Disease Research, Bangladesh
    Dhaka, Bangladesh
  • 10008-Medical Center Viva Feniks
    Dobrich, Bulgaria
  • 10007-MHAT Dr. Stamen Iliev AD
    Montana, Bulgaria
  • 10003-UMHAT Dr. Georgi Stranski EAD
    Pleven, Bulgaria
  • 10002-UMHAT Sveti Georgi EAD
    Plovdiv, Bulgaria
  • 10006-UMHAT-Plovdiv AD
    Plovdiv, Bulgaria
  • 10004-SHATPPD Dr Dimitar Gramatikov Ruse EOOD
    Ruse, Bulgaria
  • 10009-Medical Center Unimed Eood
    Sevlievo, Bulgaria
  • 20303-MUDr. Stefan Hrunka, Prakticky lekar pro deti a dorost
    Chlumec Nad Cidlinou, 503 51, Czechia
  • 20301-MUDr. Daniel Drazan, Prakticky lekar pro deti a dorost
    Jindřichův Hradec, 377 01, Czechia
  • 20304-MUDr. David Zeman s.r.o.
    Ostrava-poruba, 708 00, Czechia
  • 20302-MUDr. Daniela Pniakova s.r.o.
    Ostrava, 700 30, Czechia
  • 20305-MUDr. Iva Madejova, Prakticky lekar pro deti a dorost
    Pardubice, 530 09, Czechia
  • 23305-Vee Family Doctor's Centre
    Paide, 72713, Estonia
  • 23301-Innomedica OÜ
    Tallinn, 10117, Estonia
  • 23304-Merelahe Family Doctors Center
    Tallinn, 10617, Estonia
  • 23307-Tallinn Children's Hospital
    Tallinn, Estonia
  • 23303-Al Mare Perearstikeskus OU
    Tallin, 10617, Estonia
  • 23302-Clinical Research Centre
    Tartu, 10117, Estonia
  • 34001-Demedica
    San Pedro Sula, 21104, Honduras
  • 34003-Clínica Médica y Dental CLIMEDENTY
    Tegucigalpa, 11101, Honduras
  • 34002-Inversiones en Investigación Médica (INVERIME)
    Tegucigalpa, 2449, Honduras
  • 42802-OLVI Medical Centre
    Daugavpils, LV 1004, Latvia
  • 45804-Clinical Research Centre (CRC), Hospital Tuanku Fauziah
    Kangar, Perlis 01000, Malaysia
  • 45803-Sarawak General Hospital
    Kuching, Sarawak 93586, Malaysia
  • 45802-Hospital Sibu
    Sibu, Sarawak 96000, Malaysia
  • 45805-Klinik Kesihatan Putrajaya Presint 9
    Putrajaya, Wilyah Persekutuan Putrajaya 62250, Malaysia
  • 45801-University Malaya Medical Centre
    Kuala Lumpur, 59100, Malaysia
  • 55403-Christchurch Clinical Studies Trust
    Christchurch, 8011, New Zealand
  • 55401-Wellington Hospital
    Wellington, 6021, New Zealand
  • 58602-Shifa International Hospital
    Islamabad, Pakistan
  • 58604-The Aga Khan
    Karachi, Pakistan
  • 58605-Avicenna Hospital
    Lahore, Pakistan
  • 58607-Central Park Teaching Hospital
    Lahore, Pakistan
  • 58601-Al Shifa Research Centre
    Rawalpindi, Pakistan
  • 60808-University of the Philippines Manila Development Foundation Inc
    Ermita, Manila 1000, Philippines
  • 60810-UERM Memorial Medical Center
    Quezon City, Quezon, Philippines
  • 60817-Health Index Multispecialty Clinic
    Bacoor, Philippines
  • 60801-Chong Hua Hospital
    Cebu City, Philippines
  • 60812-De La Salle Medical and Health Sciences Institute
    Dasmariñas, Philippines
  • 60816-De La Salle Medical and Health Sciences Institute
    Dasmariñas, Philippines
  • 60806-Mary Chiles General Hospital
    Manila, 1008, Philippines
  • 60814-Philippine General Hospital
    Manila, Philippines
  • 60815-Philippine General Hospital
    Manila, Philippines
  • 60818-Philippine General Hospital
    Manila, Philippines
  • 60811-UERM Memorial Medical Center
    Quezon City, Philippines
  • 60813-Philippine Children's Medical Center
    Quezon City, Philippines
  • 61605-Osrodek Badan Klinicznych IN-VIVO sp. z o.o.
    Bydgoszcz, 85-090, Poland
  • 61603-Jerzy Brzostek Prywatny Gabinet Lekarski
    Dębica, 39-200, Poland
  • 61607-Gdanskie Centrum Zdrowia Sp. z o.o.
    Gdańsk, 80-542, Poland
  • 61604-Hanna Czajka, Indywidualna Specjalistyczna Praktyka Lekarska
    Kraków, 31-302, Poland
  • 61608-Gabinet Lekarski Bartosz Korczowski
    Rzeszów, 35-302, Poland
  • 61602-Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice
    Siemianowice Śląskie, 41-103, Poland
  • 61601-ETG Network- Skierniewice,Clinmed Research
    Skierniewice, 96-100, Poland
  • 61609-Szpital im. Swietej Jadwigi Slaskiej w Trzebnicy
    Trzebnica, 55-100, Poland
  • 64201-SC Sana Monitoring SRL.
    Bucuresti, 011025, Romania
  • 64202-Spitalul Municipal Caracal
    Caracal, 235200, Romania
  • 64205-Sc Med Fam Apolo srl
    Călăraşi, 910160, Romania
  • 64206-S.C Centrul Clinic Mediquest S.R.L
    Sângeorgiu De Mureş, 547530, Romania
  • 71006-Madibeng Centre for Research
    Brits, South Africa
  • 71004-Tread Research
    Cape Town, South Africa
  • 71007-Allergy & Immunology Unit
    Cape Town, South Africa
  • 71002-Synergy Biomed Research Institute
    East London, South Africa
  • 71009-Perinatal HIV Research Unit, Tshepong Hospital
    Klerksdorp, South Africa
  • 71001-Be Part Yoluntu Centre
    Paarl, South Africa
  • 71008-Clinical Trial Systems
    Pretoria, South Africa
  • 71003-Soweto Clinical Trials Centre
    Soweto, South Africa
  • 71005-Limpopo Clinical Research Initiative
    Thabazimbi, South Africa
  • 76405-Phramongkutklao Hospital
    Ratchathewi, Bangkok 10400, Thailand
  • 76401-Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University
    Bangkok, 10400, Thailand
  • 76404-Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University
    Bangkok, 10400, Thailand
  • 80404-Reg Mun NPE Chernivtsi RCCH Infectious Dept for Infants SHEI of UBSMU
    Chernivtsi, 58023, Ukraine
  • 80405-CI Dnipro Children's City CH #5 of Dnipro City Council
    Dnipro, 49027, Ukraine
  • 80401-Vinnytsia RCCH Policlinic Dept Vinnytsia M.I.Pyrogov NMU
    Vinnytsia, 21000, Ukraine
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — Seqirus will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact Seqirus at seqirus.clinicaltrials@seqirus.com.

Supporting information: Study protocol, Statistical analysis plan

Time frame: Requests for IPD will generally be considered once review by major regulatory authorities (ie FDA, EMA) is complete and the primary publication is available.

Access criteria: Proposed research should seek to answer a previously unanswered important medical or scientific question. Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD. If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03932682
Lead sponsor
Seqirus
Responsible party
Sponsor
First posted
May 1, 2019
Start date
May 13, 2019
Primary completion
Nov 30, 2023
Completion
Feb 13, 2024
Results posted
Mar 4, 2025
Last update
Mar 4, 2025

Study contacts

Clinical Program Director
study director · Seqirus

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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