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CompletedNCT01196975Updated Sep 21, 2018Results posted

A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Adults

A Phase 3 interventional study of Quadrivalent seasonal influenza vaccine GSK2282512A and FluLavalTM-VB in Influenza, sponsored by GlaxoSmithKline. Completed at 12 sites in 3 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-21.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
1,707
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study is designed to test the immunogenicity and safety of an investigational influenza vaccine, in adults compared to two other influenza vaccines.

This study will also evaluate the lot-to-lot consistency of three vaccine lots.

02

Conditions studied

  • Influenza

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Keywords

  • Influenza
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 1,707 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Subjects who the investigator believes can and will comply with the requirements of the protocol
  • A male or female 18 years of age or older, in stable health, as established by medical history and physical examination before entering into the study.
  • Written informed consent obtained from the subject.
  • Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line, or mobile, but NOT a pay phone or other multiple-user device.
  • Female subjects of non-childbearing potential may be enrolled in the study.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject:
    • has practiced adequate contraception for 30 days prior to vaccination, and
    • has a negative pregnancy test on the day of vaccination, and
    • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion criteria

Exclusion Criteria:

  • Use of an investigational / non-registered product other than the study vaccines within 30 days before study vaccination or planned use during study period.
  • Planned administration or administration of a licensed vaccine within 30 days before study vaccination.
  • Prior receipt of 2010/2011 influenza vaccine.
  • Receipt of any investigational or approved influenza vaccine within six months of the first study visit.
  • Any known or suspected allergy to any constituent of influenza vaccines ; a history of anaphylactic-type reaction to constituent of vaccine; or a history of severe adverse reaction to a previous influenza vaccine.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
  • History of Guillain-Barre syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
  • Presence or evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the investigator to render the potential subject unable / unlikely to provide accurate safety reports.
  • Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, based on history and physical examination.
  • Presence of significant uncontrolled chronic medical or neuropsychiatric illness, based on history and physical examination
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin
  • Chronic administration of immunosuppressants or other immune-modifying drugs within 3 months prior to the first vaccine/product dose.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
  • Pregnant or lactating female.
  • Fever at the time of enrolment.
  • Acute disease at the time of enrolment
  • Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
1,707 participants (actual)

Study arms

  • Experimental
    GSK2282512A 1 Group

    Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

    Biological: Quadrivalent seasonal influenza vaccine GSK2282512A

  • Experimental
    GSK2282512A 2 Group

    Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

    Biological: Quadrivalent seasonal influenza vaccine GSK2282512A

  • Experimental
    GSK2282512A 3 Group

    Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

    Biological: Quadrivalent seasonal influenza vaccine GSK2282512A

  • Active comparator
    Victoria Strain FluLaval Group

    Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

    Biological: FluLavalTM-VB

  • Active comparator
    Yamagata Strain FluLaval Group

    Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

    Biological: FluLavalTM-YB

Interventions

  • BiologicalQuadrivalent seasonal influenza vaccine GSK2282512A

    Single intramuscular dose

    Also known as: GSK2282512A

  • BiologicalFluLavalTM-VB

    Single intramuscular dose

    Also known as: FluLavalTM containing the Victoria B flu strain, FluLaval®-VB, Victoria Strain FluLaval vaccine

  • BiologicalFluLavalTM-YB

    Single intramuscular dose

    Also known as: FluLavalTM containing the Yamagata B flu strain, FluLaval®-YB

06

What researchers measure

Primary outcomes

  1. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease

    Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Results for Day 21 for the subjects in the GSK2282512A Group are the results specific to this primary outcome measure.

    Time frame: At Day 0 (D0) and at Day 21 (D21) post vaccination.

Secondary outcomes

  1. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata

    Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y.

    Time frame: At Day 0 (D0) and at Day 21 (D21) post vaccination.

  2. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata

    Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y.

    Time frame: At Day 0 (D0), and at Day 21 (D21) and Day 180 (D180) post vaccination.

  3. Number of Subjects With Medically-attended Adverse Events (MAEs)

    Medically-attended adverse events (MAEs) were non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a medically-attended adverse event was leading to hospitalization (or met any other serious adverse event \[SAE\] criterion), it was reported as SAE.

    Time frame: From the beginning of the study until study end (from Day 0 to Day 180)

  4. Number of Subjects With Related Medically-attended Adverse Events (MAEs)

    Medically-attended adverse events (MAEs) were non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a medically-attended adverse event was leading to hospitalization (or met any other serious adverse event \[SAE\] criterion), it was reported as SAE. Related MAE = MAE assessed by the investigator to be causally related to vaccination. Relationship to vaccination was not computed for MAEs.

    Time frame: From the beginning of the study until study end (from Day 0 to Day 180) .

  5. Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs)

    Potential immune-mediated diseases (pIMDs) are a subset of adverse events that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related pIMD = pIMD assessed by the investigator to be causally related to vaccination.

    Time frame: From the beginning of the study until study end (from Day 0 to Day 180) .

  6. Number of Subjects With Any and Related Serious Adverse Events (SAEs)

    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

    Time frame: From the beginning of the study until study end (from Day 0 to Day 180)

  7. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata

    Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y.

    Time frame: At Day 0 (D0), and at Day 21 (D21) and Day 180 (D180) post vaccination.

  8. Number of Seroprotected Subjects Against 4 Strains of Influenza Disease

    A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains

    Time frame: At Day 0 (D0) and at Day 21 (D21) after vaccination.

  9. Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata

    A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y.

    Time frame: At Day 0 (D0) and at Day 21 (D21) after vaccination.

  10. Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata

    A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y.

    Time frame: At Day 0 (D0) and at Day 21 (D21) after vaccination

  11. Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata

    A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y.

    Time frame: At Day 21 (D21) after vaccination.

  12. Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata

    The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the Day 21 reciprocal HI titer to the Day 0 reciprocal HI titer). The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y.

    Time frame: At Day 21 (D21) after vaccination

  13. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata

    Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y.

    Time frame: At Day 0 (D0) and at Day 21 (D21) post vaccination.

  14. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease

    Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains.

    Time frame: At Day 0 (D0), and at Day 21 (D21) and Day 180 (D180) post vaccination.

  15. Number of Seroconverted Subjects Against 4 Strains of Influenza

    A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains.

    Time frame: At Day 21 (D21) after vaccination.

  16. Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata

    A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y.

    Time frame: At Day 21 (D21) after vaccination.

  17. Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata

    The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the Day 21 reciprocal HI titer to the Day 0 reciprocal HI titer). The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y.

    Time frame: At Day 21 (D21) post vaccination.

  18. Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease

    The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the Day 21 reciprocal HI titer to the Day 0 reciprocal HI titer). The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains.

    Time frame: At Day 21 (D21) post vaccination.

  19. Number of Subjects With Any and Grade 3 Solicited Local Symptoms

    Assessed solicited local symptoms were pain, redness and swelling at the injection site. Grade 3 pain = significant pain at rest/pain that prevented normal everyday activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

    Time frame: Within the 7-day (Days 0-6) follow-up period after vaccination

  20. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

    Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (Gastr. Symptoms), headache, muscle ache, shivering, temperature - oral temperature equal to or above (≥) 38.0 degrees Celsius (°C) - and joint pain at location other than the injection site (Joint Pain). Grade 3 temperature = temperature ≥ 39.0 °C. Grade 3 symptom = symptom that prevented normal everyday activity. Related symptom = symptom assessed by the investigator as causally related to study vaccination. Joint pain data were collected for subjects in Canada and Mexico only.

    Time frame: Within the 7-day (Days 0-6) follow-up period after vaccination

  21. Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

    Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal everyday activity Related: unsolicited AE assessed by the investigator as related to the vaccination.

    Time frame: Within the 21-day (Days 0-20) follow-up period after vaccination

  22. Number of Days With Solicited Local Symptoms After Vaccination.

    Solicited local symptoms were pain, redness and swelling at the injection site. Analyses of duration for solicited local symptoms were not performed.

    Time frame: Within the 7-day follow-up period after vaccination (Days 0-6)

  23. Number of Days With Solicited General Symptoms After Vaccination

    Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (Gastr.), headache, muscle ache, shivering, temperature (defined as oral temperature equal to or above 38.0 degrees Celsius) and joint pain at location other than the injection site (Joint Pain). Joint pain data were collected for subjects in Canada and Mexico only. Analyses of duration for solicited general symptoms were not performed.

    Time frame: Within the 7-day follow-up period after vaccination (Days 0-6)

  24. Number of Days With Unsolicited Adverse Events (AEs) After Vaccination

    Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any: any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal everyday activity. Analyses of duration for unsolicited AEs were not performed.

    Time frame: Within the 21-day (Days 0-20) follow-up period post vaccination

07

Results

Posted Dec 24, 2012
Limitations and caveats
Analyses of duration for solicited local and general and unsolicited adverse events were not performed. Relationship to vaccination was not computed for medically-attended adverse events. Joint pain data were collected in Canada and Mexico only.

Participant flow

1703 of the 1707 subjects enrolled in the study were actually administered vaccination. The other 4 subjects were not vaccinated due to failing at meeting protocol specific criteria.

Participant flow — Overall Study
MilestoneGSK2282512A 1 GroupGSK2282512A 2 GroupGSK2282512A 3 GroupVictoria Strain FluLaval GroupYamagata Strain FluLaval Group
Started423424425213218
Completed408415420207205
Not completed1595613
Withdrew: Adverse event22002
Withdrew: Withdrawal by subject21010
Withdrew: Lost to follow-up1165511

Outcome measures

PrimaryTiters for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease

Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Results for Day 21 for the subjects in the GSK2282512A Group are the results specific to this primary outcome measure.

Time frame:
At Day 0 (D0) and at Day 21 (D21) post vaccination.
Reported as:
Geometric mean · Titer
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease
TiterGSK2282512A GroupVictoria Strain FluLaval GroupYamagata Strain FluLaval Group
H1N1, D016.9 (15.7 to 18.2)19.1 (15.8 to 23.1)16.5 (13.9 to 19.6)
H1N1, D21204.6 (190.4 to 219.9)176.0 (149.1 to 207.7)149.0 (122.9 to 180.7)
H3N1, D016.0 (15.0 to 17.1)13.9 (11.8 to 16.4)14.9 (12.7 to 17.5)
H3N1, D21125.4 (117.4 to 133.9)147.5 (124.1 to 175.2)141.0 (118.1 to 168.3)
BRI, D027.9 (26.0 to 30.0)29.4 (24.7 to 35.0)26.7 (22.8 to 31.4)
BRI, D21177.7 (167.8 to 188.1)135.9 (118.1 to 156.5)71.9 (61.3 to 84.2)
FLO, D076.2 (71.1 to 81.5)68.1 (58.5 to 79.2)70.3 (59.8 to 82.6)
FLO, D21399.7 (378.1 to 422.6)176.9 (153.8 to 203.5)306.6 (266.2 to 353.3)
SecondaryTiters for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata

Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y.

Time frame:
At Day 0 (D0) and at Day 21 (D21) post vaccination.
Reported as:
Geometric mean · titer
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata
titerGSK2282512A 18-64Y GroupGSK2282512A ≥ 65Y GroupVictoria Strain FluLaval 18-64Y GroupVictoria Strain FluLaval ≥ 65Y GroupYamagata Strain FluLaval 18-64Y GroupYamagata Strain FluLaval ≥ 65Y Group
H1N1, D019.0 (17.4 to 20.9)13.2 (11.7 to 14.7)20.3 (16.0 to 25.8)16.8 (12.3 to 22.9)18.7 (15.0 to 23.2)12.6 (9.6 to 16.5)
H1N1, D21289.4 (267.9 to 312.7)97.4 (85.9 to 110.5)236.9 (199.7 to 281.1)97.1 (70.3 to 134.1)198.5 (161.7 to 243.7)80.8 (55.1 to 118.5)
H3N1, D015.2 (14.0 to 16.6)17.8 (15.9 to 19.9)15.0 (12.1 to 18.4)12.0 (9.1 to 15.8)14.8 (12.1 to 18.1)15.1 (11.6 to 19.7)
H3N1, D21136.1 (125.9 to 147.2)105.1 (93.4 to 118.3)176.3 (144.3 to 215.4)103.2 (75.1 to 141.8)173.6 (142.5 to 211.6)90.1 (63.8 to 127.3)
BRI, D021.7 (19.9 to 23.7)47.9 (42.8 to 53.5)23.8 (19.1 to 29.6)44.7 (34.1 to 58.6)22.8 (18.7 to 27.8)37.6 (28.8 to 49.1)
BRI, D21199.3 (185.9 to 213.6)139.0 (126.2 to 153.1)157.2 (131.5 to 187.9)101.6 (81.8 to 126.1)75.1 (61.2 to 92.2)65.4 (51.3 to 83.4)
FLO, D070.7 (64.8 to 77.2)89.1 (80.2 to 98.9)66.1 (54.3 to 80.4)72.2 (57.2 to 91.2)67.6 (54.8 to 83.4)76.3 (59.9 to 97.3)
FLO, D21475.3 (444.2 to 508.5)276.1 (252.8 to 301.5)204.9 (171.3 to 245.0)131.8 (107.1 to 162.3)406.1 (347.3 to 474.9)167.7 (132.0 to 212.9)
SecondaryTiters for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata

Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y.

Time frame:
At Day 0 (D0), and at Day 21 (D21) and Day 180 (D180) post vaccination.
Reported as:
Geometric mean · titer
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata
titerGSK2282512A 18-60Y GroupGSK2282512A ≥ 61Y GroupVictoria Strain FluLaval 18-60Y GroupVictoria Strain FluLaval ≥ 61Y GroupYamagata Strain FluLaval 18-60Y GroupYamagata Strain FluLaval ≥ 61Y Group
H1N1, D023.1 (17.9 to 29.8)12.0 (9.9 to 14.5)22.6 (11.6 to 44.0)18.7 (8.7 to 39.9)17.9 (10.0 to 32.1)10.2 (6.1 to 17.0)
H1N1, D21302.4 (245.8 to 372.0)105.0 (83.6 to 131.9)369.1 (216.2 to 630.0)132.2 (64.5 to 270.7)187.4 (110.4 to 318.2)81.4 (34.2 to 194.1)
H1N1, D18097.9 (80.3 to 119.3)29.1 (23.4 to 36.2)104.2 (57.0 to 190.5)55.6 (29.3 to 105.6)57.5 (33.2 to 99.4)34.8 (16.2 to 74.8)
H3N1, D015.5 (12.3 to 19.4)17.9 (14.7 to 21.8)12.0 (7.3 to 19.7)16.8 (9.1 to 30.9)12.7 (7.7 to 20.7)17.1 (9.9 to 29.6)
H3N1, D21123.2 (100.4 to 151.2)119.8 (97.6 to 147.0)163.3 (103.0 to 258.8)168.4 (82.1 to 345.6)175.9 (110.7 to 279.3)157.2 (92.3 to 267.9)
H3N1, D18040.9 (33.5 to 49.9)43.3 (36.7 to 51.1)46.1 (31.8 to 67.0)46.7 (27.6 to 79.0)63.0 (39.5 to 100.8)60.6 (35.1 to 104.6)
BRI, D022.9 (18.3 to 28.6)41.1 (33.9 to 49.8)30.7 (16.1 to 58.6)42.9 (25.4 to 72.3)17.9 (11.7 to 27.3)32.5 (18.0 to 58.6)
BRI, D21193.0 (161.0 to 231.4)167.2 (141.6 to 197.3)180.9 (120.9 to 270.7)109.3 (77.7 to 153.6)53.9 (31.0 to 93.6)74.7 (44.7 to 124.9)
BRI, D180112.8 (94.1 to 135.3)127.0 (109.1 to 147.8)130.5 (91.8 to 185.4)102.0 (78.8 to 132.0)59.3 (36.9 to 95.4)79.9 (49.8 to 128.5)
FLO, D075.4 (59.3 to 95.8)79.2 (65.5 to 95.7)92.3 (54.5 to 156.4)93.5 (54.0 to 161.7)60.3 (38.7 to 93.9)78.6 (41.6 to 148.3)
FLO, D21485.8 (407.3 to 579.5)334.3 (288.9 to 386.8)204.4 (134.8 to 310.0)187.0 (138.5 to 252.3)405.3 (273.8 to 600.0)180.6 (101.4 to 321.7)
FLO, D180311.9 (261.7 to 371.7)209.5 (183.0 to 239.8)177.3 (120.5 to 260.9)160.1 (108.8 to 235.6)320.1 (207.8 to 492.9)174.3 (104.3 to 291.2)
SecondaryNumber of Subjects With Medically-attended Adverse Events (MAEs)

Medically-attended adverse events (MAEs) were non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a medically-attended adverse event was leading to hospitalization (or met any other serious adverse event \[SAE\] criterion), it was reported as SAE.

Time frame:
From the beginning of the study until study end (from Day 0 to Day 180)
Reported as:
Count of participants · Participants
Number of Subjects With Medically-attended Adverse Events (MAEs)
ParticipantsGSK2282512A 1 GroupGSK2282512A 2 GroupGSK2282512A 3 GroupVictoria Strain FluLaval GroupYamagata Strain FluLaval Group
Number of Subjects With Medically-attended Adverse Events (MAEs)1291011005164
SecondaryNumber of Subjects With Related Medically-attended Adverse Events (MAEs)

Medically-attended adverse events (MAEs) were non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a medically-attended adverse event was leading to hospitalization (or met any other serious adverse event \[SAE\] criterion), it was reported as SAE. Related MAE = MAE assessed by the investigator to be causally related to vaccination. Relationship to vaccination was not computed for MAEs.

Time frame:
From the beginning of the study until study end (from Day 0 to Day 180) .

No measurements were reported for this outcome.

SecondaryNumber of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs)

Potential immune-mediated diseases (pIMDs) are a subset of adverse events that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related pIMD = pIMD assessed by the investigator to be causally related to vaccination.

Time frame:
From the beginning of the study until study end (from Day 0 to Day 180) .
Reported as:
Count of participants · Participants
Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs)
ParticipantsGSK2282512A 1 GroupGSK2282512A 2 GroupGSK2282512A 3 GroupVictoria Strain FluLaval GroupYamagata Strain FluLaval Group
Subject(s) with Any pIMD(s)11101
Subject(s) with Related pIMD(s)00000
SecondaryNumber of Subjects With Any and Related Serious Adverse Events (SAEs)

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

Time frame:
From the beginning of the study until study end (from Day 0 to Day 180)
Reported as:
Count of participants · Participants
Number of Subjects With Any and Related Serious Adverse Events (SAEs)
ParticipantsGSK2282512A 1 GroupGSK2282512A 2 GroupGSK2282512A 3 GroupVictoria Strain FluLaval GroupYamagata Strain FluLaval Group
Subject(s) with Any SAE(s)1513737
Subject(s) with Related SAE(s)00000
SecondaryTiters for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata

Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y.

Time frame:
At Day 0 (D0), and at Day 21 (D21) and Day 180 (D180) post vaccination.
Reported as:
Geometric mean · Titer
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata
TiterGSK2282512A 18-64Y GroupGSK2282512A ≥ 65Y GroupVictoria Strain FluLaval 18-64Y GroupVictoria Strain FluLaval ≥ 65Y GroupYamagata Strain FluLaval 18-64Y GroupYamagata Strain FluLaval ≥ 65Y Group
H1N1, D022.7 (17.8 to 29.0)11.6 (9.6 to 14.2)23.3 (12.4 to 43.7)17.9 (8.1 to 39.8)18.0 (10.3 to 31.4)9.8 (5.7 to 16.8)
H1N1, D21293.3 (240.7 to 357.3)100.5 (79.1 to 127.7)339.0 (199.0 to 577.6)135.7 (63.7 to 289.2)180.6 (108.4 to 300.8)81.5 (32.5 to 204.3)
H1N1, D18095.5 (79.1 to 115.3)27.4 (21.8 to 34.4)98.8 (55.5 to 176.0)56.6 (28.7 to 111.4)56.6 (33.5 to 95.4)34.5 (15.4 to 77.6)
H3N1, D015.3 (12.2 to 19.1)18.4 (15.1 to 22.3)13.3 (8.0 to 22.4)15.5 (8.3 to 28.8)12.2 (7.5 to 19.6)18.2 (10.4 to 32.2)
H3N1, D21115.0 (93.2 to 141.9)128.6 (105.4 to 156.8)163.1 (105.8 to 251.3)168.9 (79.0 to 361.3)175.1 (112.7 to 272.2)157.1 (89.4 to 276.0)
H3N1, D18041.3 (34.0 to 50.0)43.1 (36.3 to 51.0)49.4 (33.8 to 72.2)43.8 (25.6 to 74.9)61.9 (39.5 to 96.9)61.9 (34.8 to 110.1)
BRI, D023.1 (18.6 to 28.6)42.5 (34.8 to 51.8)29.9 (16.3 to 55.1)44.6 (25.9 to 77.0)19.7 (12.6 to 30.8)29.9 (16.5 to 54.2)
BRI, D21183.6 (154.3 to 218.6)174.3 (146.6 to 207.1)166.4 (109.6 to 252.5)115.2 (81.9 to 162.0)56.5 (33.1 to 96.5)71.8 (41.9 to 122.8)
BRI, D180111.1 (93.6 to 131.8)130.2 (111.0 to 152.7)124.6 (88.4 to 175.7)105.2 (80.8 to 137.0)63.8 (39.6 to 102.9)74.3 (46.2 to 119.5)
FLO, D078.5 (62.4 to 98.8)76.1 (62.6 to 92.6)98.9 (59.1 to 165.6)87.6 (50.0 to 153.7)64.8 (41.4 to 101.5)73.0 (38.0 to 140.0)
FLO, D21473.4 (399.7 to 560.6)334.4 (287.4 to 389.1)209.5 (141.3 to 310.8)181.7 (133.2 to 248.0)401.2 (275.9 to 583.3)175.3 (95.5 to 321.6)
FLO, D180314.1 (266.4 to 370.4)202.1 (175.6 to 232.7)190.4 (128.6 to 281.9)148.8 (102.3 to 216.6)329.9 (217.6 to 500.1)162.8 (96.6 to 274.2)
SecondaryNumber of Seroprotected Subjects Against 4 Strains of Influenza Disease

A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains

Time frame:
At Day 0 (D0) and at Day 21 (D21) after vaccination.
Reported as:
Count of participants · Participants
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease
ParticipantsGSK2282512A GroupVictoria Strain FluLaval GroupYamagata Strain FluLaval Group
H1N1, D04237863
H1N1, D211168189182
H3N1, D03855564
H3N1, D211130188193
BRI, D063510398
BRI, D211201193167
FLO, D0997162168
FLO, D211244200207
SecondaryNumber of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata

A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y.

Time frame:
At Day 0 (D0) and at Day 21 (D21) after vaccination.
Reported as:
Count of participants · Participants
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata
ParticipantsGSK2282512A 18-60Y GroupGSK2282512A ≥ 61Y GroupVictoria Strain FluLaval 18-60Y GroupVictoria Strain FluLaval ≥ 61Y GroupYamagata Strain FluLaval 18-60Y GroupYamagata Strain FluLaval ≥ 61Y Group
H1N1, D030911451275013
H1N1, D217654031256412755
H3N1, D022915638174024
H3N1, D217264041226613063
BRI, D033829752515345
BRI, D217604411217210760
FLO, D0591406996310563
FLO, D217794651257513473
SecondaryNumber of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata

A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y.

Time frame:
At Day 0 (D0) and at Day 21 (D21) after vaccination
Reported as:
Count of participants · Participants
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata
ParticipantsGSK2282512A 18-64Y GroupGSK2282512A ≥ 65Y GroupVictoria Strain FluLaval 18-64Y GroupVictoria Strain FluLaval ≥ 65Y GroupYamagata Strain FluLaval 18-64Y GroupYamagata Strain FluLaval ≥ 65Y Group
H1N1, D03309355235112
H1N1, D218303381345513250
H3N1, D025113440154222
H3N1, D217843461295913756
BRI, D036626955485939
BRI, D218263751306311453
FLO, D06503471055711256
FLO, D218483961346614364
SecondaryNumber of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y.

Time frame:
At Day 21 (D21) after vaccination.
Reported as:
Count of participants · Participants
Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata
ParticipantsGSK2282512A 18-64Y GroupGSK2282512A ≥ 65Y GroupVictoria Strain FluLaval 18-64Y GroupVictoria Strain FluLaval ≥ 65Y GroupYamagata Strain FluLaval 18-64Y GroupYamagata Strain FluLaval ≥ 65Y Group
H1N1, D216672551013510236
H3N1, D215842391044510940
BRI, D2156112480195210
FLO, D2153314755139017
SecondarySeroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata

The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the Day 21 reciprocal HI titer to the Day 0 reciprocal HI titer). The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y.

Time frame:
At Day 21 (D21) after vaccination
Reported as:
Geometric mean · Titer
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata
TiterGSK2282512A 18-64Y GroupGSK2282512A ≥ 65Y GroupVictoria Strain FluLaval 18-64Y GroupVictoria Strain FluLaval ≥ 65Y GroupYamagata Strain FluLaval 18-64Y GroupYamagata Strain FluLaval ≥ 65Y Group
SCF - H1N1, D2115.2 (13.7 to 16.9)7.4 (6.4 to 8.4)11.7 (9.0 to 15.1)5.8 (4.0 to 8.3)10.5 (8.2 to 13.4)6.4 (4.3 to 9.5)
SCF - H3N1, D218.9 (8.1 to 9.8)5.9 (5.2 to 6.7)11.8 (9.2 to 15.1)8.6 (5.9 to 12.4)11.7 (9.1 to 15.1)6.0 (4.3 to 8.3)
SCF - BRI, D219.2 (8.3 to 10.1)2.9 (2.6 to 3.2)6.5 (5.1 to 8.3)2.3 (1.8 to 2.9)3.3 (2.7 to 4.1)1.7 (1.4 to 2.2)
SCF - FLO, D216.7 (6.1 to 7.4)3.1 (2.8 to 3.4)3.1 (2.6 to 3.7)1.8 (1.5 to 2.3)6.0 (4.8 to 7.5)2.2 (1.8 to 2.7)
SecondaryTiters for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata

Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y.

Time frame:
At Day 0 (D0) and at Day 21 (D21) post vaccination.
Reported as:
Geometric mean · titer
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata
titerGSK2282512A 18-60Y GroupGSK2282512A ≥ 61Y GroupVictoria Strain FluLaval 18-60Y GroupVictoria Strain FluLaval ≥ 61Y GroupYamagata Strain FluLaval 18-60Y GroupYamagata Strain FluLaval ≥ 61Y Group
H1N1, D019.5 (17.7 to 21.5)13.4 (12.0 to 14.9)20.7 (16.1 to 26.6)16.6 (12.4 to 22.3)19.3 (15.4 to 24.2)12.5 (9.7 to 16.1)
H1N1, D21306.9 (283.3 to 332.5)103.8 (92.6 to 116.3)248.3 (207.8 to 296.6)99.7 (74.7 to 133.2)212.2 (175.2 to 257.0)78.9 (54.0 to 115.3)
H3N1, D015.4 (14.1 to 16.8)17.1 (15.4 to 19.0)15.4 (12.4 to 19.1)11.8 (9.1 to 15.2)14.8 (12.0 to 18.3)15.0 (11.7 to 19.2)
H3N1, D21141.0 (130.1 to 152.9)102.9 (92.2 to 114.8)187.0 (152.0 to 229.9)99.7 (74.7 to 133.1)178.2 (145.9 to 217.7)93.0 (67.1 to 128.9)
BRI, D021.6 (19.7 to 23.7)42.8 (38.4 to 47.7)23.9 (19.1 to 29.9)41.3 (31.6 to 53.8)21.6 (17.7 to 26.5)38.9 (30.3 to 50.0)
BRI, D21204.8 (190.5 to 220.2)140.1 (128.1 to 153.1)164.4 (137.0 to 197.4)99.3 (80.7 to 122.0)73.3 (59.2 to 90.7)69.3 (55.1 to 87.3)
FLO, D070.5 (64.3 to 77.2)86.7 (78.6 to 95.6)66.4 (54.0 to 81.7)70.8 (57.2 to 87.7)64.3 (52.5 to 81.3)80.0 (63.7 to 100.4)
FLO, D21493.1 (459.3 to 529.3)281.4 (259.6 to 304.9)211.4 (175.0 to 255.3)131.9 (109.2 to 159.1)413.7 (351.2 to 487.2)180.2 (144.3 to 224.9)
SecondaryTiters for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease

Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains.

Time frame:
At Day 0 (D0), and at Day 21 (D21) and Day 180 (D180) post vaccination.
Reported as:
Geometric mean · Titer
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease
TiterGSK2282512A GroupVictoria Strain FluLaval GroupYamagata Strain FluLaval Group
H1N1, D016.4 (13.9 to 19.2)20.4 (12.5 to 33.2)13.7 (9.3 to 20.1)
H1N1, D21173.5 (146.8 to 205.0)211.9 (132.4 to 339.0)126.0 (77.0 to 206.3)
H1N1, D18051.7 (43.9 to 61.1)74.2 (48.0 to 114.7)45.3 (28.9 to 71.0)
H3N1, D016.7 (14.4 to 19.4)14.4 (9.8 to 21.2)14.6 (10.2 to 20.8)
H3N1, D21121.4 (105.1 to 140.2)166.0 (108.9 to 253.2)166.7 (119.2 to 233.3)
H3N1, D18042.1 (37.1 to 47.9)46.4 (33.9 to 63.7)61.9 (44.0 to 87.1)
BRI, D031.1 (26.8 to 36.2)36.8 (24.8 to 54.5)23.8 (16.7 to 33.9)
BRI, D21179.0 (158.4 to 202.2)137.7 (106.0 to 179.0)62.9 (43.6 to 90.8)
BRI, D180120.1 (106.8 to 134.9)114.2 (92.9 to 140.4)68.4 (49.4 to 94.6)
FLO, D077.3 (66.5 to 89.9)92.9 (64.6 to 133.7)68.4 (47.4 to 98.7)
FLO, D21399.2 (355.8 to 447.9)194.8 (153.5 to 247.2)275.8 (194.1 to 392.0)
FLO, D180253.1 (226.4 to 282.9)167.8 (129.2 to 217.8)239.6 (171.6 to 334.1)
SecondaryNumber of Seroconverted Subjects Against 4 Strains of Influenza

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains.

Time frame:
At Day 21 (D21) after vaccination.
Reported as:
Count of participants · Participants
Number of Seroconverted Subjects Against 4 Strains of Influenza
ParticipantsGSK2282512A GroupVictoria Strain FluLaval GroupYamagata Strain FluLaval Group
H1N1, D21922136138
H3N1, D21823149149
BRI, D216859962
FLO, D2168068107
SecondaryNumber of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y.

Time frame:
At Day 21 (D21) after vaccination.
Reported as:
Count of participants · Participants
Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata
ParticipantsGSK2282512A 18-60Y GroupGSK2282512A ≥ 61Y GroupVictoria Strain FluLaval 18-60Y GroupVictoria Strain FluLaval ≥ 61Y GroupYamagata Strain FluLaval 18-60Y GroupYamagata Strain FluLaval ≥ 61Y Group
H1N1, D2161630696409741
H3N1, D21544279995010445
BRI, D2152216376235111
FLO, D2150018053158819
SecondarySeroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata

The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the Day 21 reciprocal HI titer to the Day 0 reciprocal HI titer). The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y.

Time frame:
At Day 21 (D21) post vaccination.
Reported as:
Geometric mean · Titer
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata
TiterGSK2282512A 18-60Y GroupGSK2282512A ≥ 61Y GroupVictoria Strain FluLaval 18-60Y GroupVictoria Strain FluLaval ≥ 61Y GroupYamagata Strain FluLaval 18-60Y GroupYamagata Strain FluLaval ≥ 61Y Group
SCF - H1N1, D2115.8 (14.1 to 17.7)7.7 (6.8 to 8.7)12.0 (9.2 to 15.6)6.0 (4.3 to 8.5)11.0 (8.6 to 14.1)6.2 (4.3 to 9.0)
SCF - H3N1, D219.1 (8.3 to 10.1)6.0 (5.4 to 6.8)12.2 (9.3 to 15.8)8.5 (6.1 to 11.8)12.0 (9.2 to 15.6)6.2 (4.5 to 8.6)
SCF - BRI, D219.5 (8.5 to 10.5)3.3 (2.9 to 3.6)6.8 (5.3 to 8.7)2.4 (1.9 to 3.0)3.4 (2.8 to 4.1)1.8 (1.4 to 2.3)
SCF - FLO, D217.0 (6.3 to 7.7)3.2 (3.0 to 3.6)3.2 (2.6 to 3.8)1.9 (1.5 to 2.3)6.3 (5.0 to 8.0)2.3 (1.8 to 2.8)
SecondarySeroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease

The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the Day 21 reciprocal HI titer to the Day 0 reciprocal HI titer). The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains.

Time frame:
At Day 21 (D21) post vaccination.
Reported as:
Geometric mean · Titer
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease
TiterGSK2282512A GroupVictoria Strain FluLaval GroupYamagata Strain FluLaval Group
SCF - H1N1, D2112.1 (11.1 to 13.2)9.2 (7.5 to 11.4)9.0 (7.3 to 11.1)
SCF - H3N1, D217.8 (7.2 to 8.5)10.6 (8.6 to 13.0)9.5 (7.7 to 11.6)
SCF - BRI, D216.3 (5.8 to 6.9)4.6 (3.8 to 5.5)2.7 (2.3 to 3.2)
SCF - FLO, D215.2 (4.9 to 5.6)2.6 (2.3 to 3.0)4.4 (3.6 to 5.2)
SecondaryNumber of Subjects With Any and Grade 3 Solicited Local Symptoms

Assessed solicited local symptoms were pain, redness and swelling at the injection site. Grade 3 pain = significant pain at rest/pain that prevented normal everyday activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

Time frame:
Within the 7-day (Days 0-6) follow-up period after vaccination
Reported as:
Count of participants · Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
ParticipantsGSK2282512A 1 GroupGSK2282512A 2 GroupGSK2282512A 3 GroupVictoria Strain FluLaval GroupYamagata Strain FluLaval Group
Any Pain2602452459389
Grade 3 Pain95823
Any Redness811363
Grade 3 Redness00000
Any Swelling1013938
Grade 3 Swelling00000
SecondaryNumber of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (Gastr. Symptoms), headache, muscle ache, shivering, temperature - oral temperature equal to or above (≥) 38.0 degrees Celsius (°C) - and joint pain at location other than the injection site (Joint Pain). Grade 3 temperature = temperature ≥ 39.0 °C. Grade 3 symptom = symptom that prevented normal everyday activity. Related symptom = symptom assessed by the investigator as causally related to study vaccination. Joint pain data were collected for subjects in Canada and Mexico only.

Time frame:
Within the 7-day (Days 0-6) follow-up period after vaccination
Reported as:
Count of participants · Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
ParticipantsGSK2282512A 1 GroupGSK2282512A 2 GroupGSK2282512A 3 GroupVictoria Strain FluLaval GroupYamagata Strain FluLaval Group
Any Fatigue9286934537
Grade 3 Fatigue62224
Related Fatigue7072782832
Any Headache9387914149
Grade 3 Headache43410
Related Headache6660722835
Any Muscle Ache1131051135240
Grade 3 Muscle Ache24413
Related Muscle Ache9394983935
Any Shivering3937351613
Grade 3 Shivering42212
Related Shivering303027118
Any Temperature38813
Grade 3 Temperature03201
Related Temperature18602
Any Joint Pain2727341715
Grade 3 Joint Pain13113
Related Joint Pain1720211011
Any Gastr.4335392116
Grade 3 Gastr.51441
Related Gastr.342623118
SecondaryNumber of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal everyday activity Related: unsolicited AE assessed by the investigator as related to the vaccination.

Time frame:
Within the 21-day (Days 0-20) follow-up period after vaccination
Reported as:
Count of participants · Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
ParticipantsGSK2282512A 1 GroupGSK2282512A 2 GroupGSK2282512A 3 GroupVictoria Strain FluLaval GroupYamagata Strain FluLaval Group
Subject(s) with Any Unsolicited AE(s)7780874851
Subject(s) with Grade 3 Unsolicited AE(s)551567
Subject(s) with Related Unsolicited AE(s)1826211113
SecondaryNumber of Days With Solicited Local Symptoms After Vaccination.

Solicited local symptoms were pain, redness and swelling at the injection site. Analyses of duration for solicited local symptoms were not performed.

Time frame:
Within the 7-day follow-up period after vaccination (Days 0-6)

No measurements were reported for this outcome.

SecondaryNumber of Days With Solicited General Symptoms After Vaccination

Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (Gastr.), headache, muscle ache, shivering, temperature (defined as oral temperature equal to or above 38.0 degrees Celsius) and joint pain at location other than the injection site (Joint Pain). Joint pain data were collected for subjects in Canada and Mexico only. Analyses of duration for solicited general symptoms were not performed.

Time frame:
Within the 7-day follow-up period after vaccination (Days 0-6)

No measurements were reported for this outcome.

SecondaryNumber of Days With Unsolicited Adverse Events (AEs) After Vaccination

Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any: any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal everyday activity. Analyses of duration for unsolicited AEs were not performed.

Time frame:
Within the 21-day (Days 0-20) follow-up period post vaccination

No measurements were reported for this outcome.

Adverse events

Collected over Reports of solicited local and general adverse events were collected during the 7-day (Days 0-6) follow-up period following vaccination. Reports for serious adverse events were collected throughout the study, from Day 0 to Day 180.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
GSK2282512A 1 Group—15/423 (3.5%)294/417 (70.5%)
GSK2282512A 2 Group—13/424 (3.1%)286/421 (67.9%)
GSK2282512A 3 Group—7/425 (1.6%)284/422 (67.3%)
Victoria Strain FluLaval Group—3/213 (1.4%)127/208 (61.1%)
Yamagata Strain FluLaval Group—7/218 (3.2%)113/216 (52.3%)
Most frequent serious events
Showing 10 of 57
Most frequent serious events
EventGSK2282512A 1 GroupGSK2282512A 2 GroupGSK2282512A 3 GroupVictoria Strain FluLaval GroupYamagata Strain FluLaval Group
Angina unstableCardiac disorders1/4230/4240/4251/2130/218
Gastrointestinal mucosal disorderGastrointestinal disorders0/4230/4240/4251/2130/218
Upper gastrointestinal haemorrhageGastrointestinal disorders0/4230/4240/4251/2130/218
Fracture displacementInjury, poisoning and procedural complications0/4230/4240/4251/2130/218
Hip fractureInjury, poisoning and procedural complications0/4230/4240/4251/2131/218
HypoaesthesiaNervous system disorders0/4230/4240/4251/2130/218
Coronary artery diseaseCardiac disorders0/4230/4241/4250/2131/218
Hepatic cirrhosisHepatobiliary disorders0/4230/4240/4250/2131/218
Portal hypertensionHepatobiliary disorders0/4230/4240/4250/2131/218
Abscess limbInfections and infestations0/4230/4240/4250/2131/218
Most frequent other events
Most frequent other events
EventGSK2282512A 1 GroupGSK2282512A 2 GroupGSK2282512A 3 GroupVictoria Strain FluLaval GroupYamagata Strain FluLaval Group
PainGeneral disorders260/417245/421245/42293/20889/216
Muscle achesGeneral disorders113/417105/421113/42252/20840/216
HeadacheGeneral disorders93/41787/42191/42241/20849/216
FatigueGeneral disorders92/41786/42193/42245/20837/216
Gastrointestinal adverse event(s)General disorders43/41735/42139/42221/20815/216
ShiveringGeneral disorders39/41737/42135/42216/20813/216
Joint pain at other location than injection siteGeneral disorders27/41727/42134/42217/20815/216

Baseline characteristics

Age, Continuous
Age, Continuous(Years)GSK2282512A 1 GroupGSK2282512A 2 GroupGSK2282512A 3 GroupVictoria Strain FluLaval GroupYamagata Strain FluLaval GroupTotal
Mean49.9 ± 19.4950.4 ± 19.0749.8 ± 20.1050.8 ± 18.5849.6 ± 19.3450.1 ± 19.32
Sex: Female, Male
Sex: Female, Male(Participants)GSK2282512A 1 GroupGSK2282512A 2 GroupGSK2282512A 3 GroupVictoria Strain FluLaval GroupYamagata Strain FluLaval GroupTotal
Female2512642661251381044
Male1721601598880659
08

Study locations

12 sites
  • GSK Investigational Site
    Mesa, Arizona 85213, United States
  • GSK Investigational Site
    Wichita, Kansas 67207, United States
  • GSK Investigational Site
    Elkridge, Maryland 21075, United States
  • GSK Investigational Site
    Endwell, New York 13760, United States
  • GSK Investigational Site
    Jefferson Hills, Pennsylvania 15025, United States
  • GSK Investigational Site
    Wenatchee, Washington 98801, United States
  • GSK Investigational Site
    Coquitlam, British Columbia V3K 3P4, Canada
  • GSK Investigational Site
    Surrey, British Columbia V3R 8P8, Canada
  • GSK Investigational Site
    Quebec City, Quebec G1V 4M6, Canada
  • GSK Investigational Site
    Cuernavaca, Morelos, Mexico
  • GSK Investigational Site
    Durango, 3400, Mexico
  • GSK Investigational Site
    Estado de Mexico, 55075, Mexico
09

References and documents

Publications

  • Tinoco JC, Pavia-Ruz N, Cruz-Valdez A, Aranza Doniz C, Chandrasekaran V, Dewe W, Liu A, Innis BL, Jain VK. Immunogenicity, reactogenicity, and safety of inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccine in healthy adults aged >/=18 years: a phase III, randomized trial. Vaccine. 2014 Mar 14;32(13):1480-7. doi: 10.1016/j.vaccine.2014.01.022. Epub 2014 Jan 28. PubMed 24486352 ↗

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01196975
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Sep 9, 2010
Start date
Oct 1, 2010
Primary completion
Jan 25, 2011
Completion
Jun 24, 2011
Results posted
Dec 24, 2012
Last update
Sep 21, 2018

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

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