Influenza
Conditions
Keywords
Influenza
Brief 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.
Interventions
Single intramuscular dose
BIOLOGICALFluLavalTM-VB
Single intramuscular dose
BIOLOGICALFluLavalTM-YB
Single intramuscular dose
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | At Day 0 (D0) and at Day 21 (D21) post vaccination. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | At Day 0 (D0) and at Day 21 (D21) post vaccination. | 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. |
| Number of Subjects With Medically-attended Adverse Events (MAEs) | From the beginning of the study until study end (from Day 0 to Day 180) | 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. |
| Number of Subjects With Related Medically-attended Adverse Events (MAEs) | From the beginning of the study until study end (from Day 0 to Day 180) . | 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. |
| Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) | From the beginning of the study until study end (from Day 0 to Day 180) . | 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. |
| Number of Subjects With Any and Related Serious Adverse Events (SAEs) | From the beginning of the study until study end (from Day 0 to Day 180) | 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. |
| Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | At Day 0 (D0) and at Day 21 (D21) after vaccination. | 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 |
| Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | At Day 0 (D0) and at Day 21 (D21) after vaccination. | 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. |
| Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | At Day 21 (D21) after vaccination. | 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. |
| Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | At Day 21 (D21) after vaccination | 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. |
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | At Day 0 (D0), and at Day 21 (D21) and Day 180 (D180) post vaccination. | 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. |
| Number of Seroconverted Subjects Against 4 Strains of Influenza | At Day 21 (D21) after vaccination. | 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. |
| Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | At Day 21 (D21) post vaccination. | 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. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Within the 7-day (Days 0-6) follow-up period after vaccination | 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. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Within the 7-day (Days 0-6) follow-up period after vaccination | 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. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Within the 21-day (Days 0-20) follow-up period 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 Related: unsolicited AE assessed by the investigator as related to the vaccination. |
| Number of Days With Solicited Local Symptoms After Vaccination. | Within the 7-day follow-up period after vaccination (Days 0-6) | Solicited local symptoms were pain, redness and swelling at the injection site. Analyses of duration for solicited local symptoms were not performed. |
| Number of Days With Solicited General Symptoms After Vaccination | Within the 7-day follow-up period after vaccination (Days 0-6) | 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. |
| Number of Days With Unsolicited Adverse Events (AEs) After Vaccination | Within the 21-day (Days 0-20) follow-up period post 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. |
Countries
Canada, Mexico, United States
Participant flow
Recruitment details
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.
Pre-assignment details
For some outcome measures, the subjects receiving the GSK2282512A vaccine, from Lot 1, 2 or 3, were pooled into one larger pooled group, the GSK2282512A Group, and/or groups were stratified into the 4 age categories: 18 to 60 years (18-60Y), 61 years and older (≥61Y), 18 to 64 years (18-64Y), and 65 years and older (≥ 65Y).
Participants by arm
| Arm | Count |
|---|---|
| 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 | 423 |
| 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. | 424 |
| 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. | 425 |
| 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. | 213 |
| 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. | 218 |
| Total | 1,703 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 | 0 | 0 | 2 |
| Overall Study | Lost to Follow-up | 11 | 6 | 5 | 5 | 11 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Total | GSK2282512A 1 Group | GSK2282512A 2 Group | GSK2282512A 3 Group | Victoria Strain FluLaval Group | Yamagata Strain FluLaval Group |
|---|---|---|---|---|---|---|
| Age, Continuous | 50.1 Years STANDARD_DEVIATION 19.32 | 49.9 Years STANDARD_DEVIATION 19.49 | 50.4 Years STANDARD_DEVIATION 19.07 | 49.8 Years STANDARD_DEVIATION 20.1 | 50.8 Years STANDARD_DEVIATION 18.58 | 49.6 Years STANDARD_DEVIATION 19.34 |
| Sex: Female, Male Female | 1044 Participants | 251 Participants | 264 Participants | 266 Participants | 125 Participants | 138 Participants |
| Sex: Female, Male Male | 659 Participants | 172 Participants | 160 Participants | 159 Participants | 88 Participants | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 294 / 417 | 286 / 421 | 284 / 422 | 127 / 208 | 113 / 216 |
| serious Total, serious adverse events | 15 / 423 | 13 / 424 | 7 / 425 | 3 / 213 | 7 / 218 |
Outcome results
Primary
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.
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H1N1, D0 | 16.9 Titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H1N1, D21 | 204.6 Titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H3N1, D0 | 16.0 Titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H3N1, D21 | 125.4 Titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | BRI, D0 | 27.9 Titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | BRI, D21 | 177.7 Titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | FLO, D0 | 76.2 Titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | FLO, D21 | 399.7 Titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H3N1, D0 | 13.9 Titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | FLO, D0 | 68.1 Titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H3N1, D21 | 147.5 Titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | BRI, D0 | 29.4 Titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | BRI, D21 | 135.9 Titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H1N1, D0 | 19.1 Titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H1N1, D21 | 176.0 Titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | FLO, D21 | 176.9 Titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H3N1, D0 | 14.9 Titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H1N1, D21 | 149.0 Titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H1N1, D0 | 16.5 Titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H3N1, D21 | 141.0 Titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | FLO, D0 | 70.3 Titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | BRI, D21 | 71.9 Titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | BRI, D0 | 26.7 Titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | FLO, D21 | 306.6 Titer |
Secondary
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)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, on subjects for whom results were available.
Secondary
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)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, on subjects for whom results were available.
Secondary
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
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
Secondary
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.
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2282512A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza | H3N1, D21 | 823 Participants |
| GSK2282512A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza | H1N1, D21 | 922 Participants |
| GSK2282512A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza | FLO, D21 | 680 Participants |
| GSK2282512A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza | BRI, D21 | 685 Participants |
| Victoria Strain FluLaval Group | Number of Seroconverted Subjects Against 4 Strains of Influenza | H1N1, D21 | 136 Participants |
| Victoria Strain FluLaval Group | Number of Seroconverted Subjects Against 4 Strains of Influenza | FLO, D21 | 68 Participants |
| Victoria Strain FluLaval Group | Number of Seroconverted Subjects Against 4 Strains of Influenza | BRI, D21 | 99 Participants |
| Victoria Strain FluLaval Group | Number of Seroconverted Subjects Against 4 Strains of Influenza | H3N1, D21 | 149 Participants |
| Yamagata Strain FluLaval Group | Number of Seroconverted Subjects Against 4 Strains of Influenza | FLO, D21 | 107 Participants |
| Yamagata Strain FluLaval Group | Number of Seroconverted Subjects Against 4 Strains of Influenza | BRI, D21 | 62 Participants |
| Yamagata Strain FluLaval Group | Number of Seroconverted Subjects Against 4 Strains of Influenza | H3N1, D21 | 149 Participants |
| Yamagata Strain FluLaval Group | Number of Seroconverted Subjects Against 4 Strains of Influenza | H1N1, D21 | 138 Participants |
Secondary
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.
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2282512A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | H1N1, D21 | 667 Participants |
| GSK2282512A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | H3N1, D21 | 584 Participants |
| GSK2282512A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | BRI, D21 | 561 Participants |
| GSK2282512A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | FLO, D21 | 533 Participants |
| Victoria Strain FluLaval Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | BRI, D21 | 124 Participants |
| Victoria Strain FluLaval Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | H3N1, D21 | 239 Participants |
| Victoria Strain FluLaval Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | H1N1, D21 | 255 Participants |
| Victoria Strain FluLaval Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | FLO, D21 | 147 Participants |
| Yamagata Strain FluLaval Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | FLO, D21 | 55 Participants |
| Yamagata Strain FluLaval Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | BRI, D21 | 80 Participants |
| Yamagata Strain FluLaval Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | H3N1, D21 | 104 Participants |
| Yamagata Strain FluLaval Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | H1N1, D21 | 101 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | H1N1, D21 | 35 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | FLO, D21 | 13 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | H3N1, D21 | 45 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | BRI, D21 | 19 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | BRI, D21 | 52 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | FLO, D21 | 90 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | H3N1, D21 | 109 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | H1N1, D21 | 102 Participants |
| Yamagata Strain FluLaval ≥ 65Y Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | H3N1, D21 | 40 Participants |
| Yamagata Strain FluLaval ≥ 65Y Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | BRI, D21 | 10 Participants |
| Yamagata Strain FluLaval ≥ 65Y Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | FLO, D21 | 17 Participants |
| Yamagata Strain FluLaval ≥ 65Y Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | H1N1, D21 | 36 Participants |
Secondary
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.
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2282512A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | H1N1, D21 | 616 Participants |
| GSK2282512A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | H3N1, D21 | 544 Participants |
| GSK2282512A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | BRI, D21 | 522 Participants |
| GSK2282512A Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | FLO, D21 | 500 Participants |
| Victoria Strain FluLaval Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | BRI, D21 | 163 Participants |
| Victoria Strain FluLaval Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | H3N1, D21 | 279 Participants |
| Victoria Strain FluLaval Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | H1N1, D21 | 306 Participants |
| Victoria Strain FluLaval Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | FLO, D21 | 180 Participants |
| Yamagata Strain FluLaval Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | FLO, D21 | 53 Participants |
| Yamagata Strain FluLaval Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | BRI, D21 | 76 Participants |
| Yamagata Strain FluLaval Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | H3N1, D21 | 99 Participants |
| Yamagata Strain FluLaval Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | H1N1, D21 | 96 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | H1N1, D21 | 40 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | FLO, D21 | 15 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | H3N1, D21 | 50 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | BRI, D21 | 23 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | BRI, D21 | 51 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | FLO, D21 | 88 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | H3N1, D21 | 104 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | H1N1, D21 | 97 Participants |
| Yamagata Strain FluLaval ≥ 65Y Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | H3N1, D21 | 45 Participants |
| Yamagata Strain FluLaval ≥ 65Y Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | BRI, D21 | 11 Participants |
| Yamagata Strain FluLaval ≥ 65Y Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | FLO, D21 | 19 Participants |
| Yamagata Strain FluLaval ≥ 65Y Group | Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata | H1N1, D21 | 41 Participants |
Secondary
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.
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2282512A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | H1N1, D21 | 1168 Participants |
| GSK2282512A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | H3N1, D0 | 385 Participants |
| GSK2282512A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | FLO, D0 | 997 Participants |
| GSK2282512A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | H1N1, D0 | 423 Participants |
| GSK2282512A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | H3N1, D21 | 1130 Participants |
| GSK2282512A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | BRI, D21 | 1201 Participants |
| GSK2282512A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | FLO, D21 | 1244 Participants |
| GSK2282512A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | BRI, D0 | 635 Participants |
| Victoria Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | FLO, D21 | 200 Participants |
| Victoria Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | BRI, D21 | 193 Participants |
| Victoria Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | FLO, D0 | 162 Participants |
| Victoria Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | H1N1, D21 | 189 Participants |
| Victoria Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | BRI, D0 | 103 Participants |
| Victoria Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | H3N1, D0 | 55 Participants |
| Victoria Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | H3N1, D21 | 188 Participants |
| Victoria Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | H1N1, D0 | 78 Participants |
| Yamagata Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | FLO, D21 | 207 Participants |
| Yamagata Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | H1N1, D0 | 63 Participants |
| Yamagata Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | H1N1, D21 | 182 Participants |
| Yamagata Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | H3N1, D0 | 64 Participants |
| Yamagata Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | H3N1, D21 | 193 Participants |
| Yamagata Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | BRI, D0 | 98 Participants |
| Yamagata Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | BRI, D21 | 167 Participants |
| Yamagata Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease | FLO, D0 | 168 Participants |
Secondary
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.
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2282512A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H3N1, D0 | 229 Participants |
| GSK2282512A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H1N1, D21 | 765 Participants |
| GSK2282512A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H1N1, D0 | 309 Participants |
| GSK2282512A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H3N1, D21 | 726 Participants |
| GSK2282512A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | BRI, D0 | 338 Participants |
| GSK2282512A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | BRI, D21 | 760 Participants |
| GSK2282512A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | FLO, D0 | 591 Participants |
| GSK2282512A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | FLO, D21 | 779 Participants |
| Victoria Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H3N1, D21 | 404 Participants |
| Victoria Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | FLO, D21 | 465 Participants |
| Victoria Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H1N1, D0 | 114 Participants |
| Victoria Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | FLO, D0 | 406 Participants |
| Victoria Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | BRI, D21 | 441 Participants |
| Victoria Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H3N1, D0 | 156 Participants |
| Victoria Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H1N1, D21 | 403 Participants |
| Victoria Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | BRI, D0 | 297 Participants |
| Yamagata Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H1N1, D21 | 125 Participants |
| Yamagata Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H3N1, D0 | 38 Participants |
| Yamagata Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H3N1, D21 | 122 Participants |
| Yamagata Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | FLO, D21 | 125 Participants |
| Yamagata Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | BRI, D0 | 52 Participants |
| Yamagata Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | BRI, D21 | 121 Participants |
| Yamagata Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | FLO, D0 | 99 Participants |
| Yamagata Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H1N1, D0 | 51 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | FLO, D0 | 63 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | BRI, D21 | 72 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | BRI, D0 | 51 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H1N1, D0 | 27 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H3N1, D0 | 17 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H3N1, D21 | 66 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | FLO, D21 | 75 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H1N1, D21 | 64 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | FLO, D21 | 134 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H1N1, D0 | 50 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | BRI, D0 | 53 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | BRI, D21 | 107 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | FLO, D0 | 105 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H1N1, D21 | 127 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H3N1, D0 | 40 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H3N1, D21 | 130 Participants |
| Yamagata Strain FluLaval ≥ 65Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | FLO, D21 | 73 Participants |
| Yamagata Strain FluLaval ≥ 65Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | BRI, D0 | 45 Participants |
| Yamagata Strain FluLaval ≥ 65Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H3N1, D0 | 24 Participants |
| Yamagata Strain FluLaval ≥ 65Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H3N1, D21 | 63 Participants |
| Yamagata Strain FluLaval ≥ 65Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | BRI, D21 | 60 Participants |
| Yamagata Strain FluLaval ≥ 65Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H1N1, D21 | 55 Participants |
| Yamagata Strain FluLaval ≥ 65Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | FLO, D0 | 63 Participants |
| Yamagata Strain FluLaval ≥ 65Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H1N1, D0 | 13 Participants |
Secondary
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
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2282512A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H3N1, D0 | 251 Participants |
| GSK2282512A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H1N1, D21 | 830 Participants |
| GSK2282512A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H1N1, D0 | 330 Participants |
| GSK2282512A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H3N1, D21 | 784 Participants |
| GSK2282512A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | BRI, D0 | 366 Participants |
| GSK2282512A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | BRI, D21 | 826 Participants |
| GSK2282512A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | FLO, D0 | 650 Participants |
| GSK2282512A Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | FLO, D21 | 848 Participants |
| Victoria Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H3N1, D21 | 346 Participants |
| Victoria Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | FLO, D21 | 396 Participants |
| Victoria Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H1N1, D0 | 93 Participants |
| Victoria Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | FLO, D0 | 347 Participants |
| Victoria Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | BRI, D21 | 375 Participants |
| Victoria Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H3N1, D0 | 134 Participants |
| Victoria Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H1N1, D21 | 338 Participants |
| Victoria Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | BRI, D0 | 269 Participants |
| Yamagata Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H1N1, D21 | 134 Participants |
| Yamagata Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H3N1, D0 | 40 Participants |
| Yamagata Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H3N1, D21 | 129 Participants |
| Yamagata Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | FLO, D21 | 134 Participants |
| Yamagata Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | BRI, D0 | 55 Participants |
| Yamagata Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | BRI, D21 | 130 Participants |
| Yamagata Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | FLO, D0 | 105 Participants |
| Yamagata Strain FluLaval Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H1N1, D0 | 55 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | FLO, D0 | 57 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | BRI, D21 | 63 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | BRI, D0 | 48 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H1N1, D0 | 23 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H3N1, D0 | 15 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H3N1, D21 | 59 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | FLO, D21 | 66 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H1N1, D21 | 55 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | FLO, D21 | 143 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H1N1, D0 | 51 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | BRI, D0 | 59 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | BRI, D21 | 114 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | FLO, D0 | 112 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H1N1, D21 | 132 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H3N1, D0 | 42 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H3N1, D21 | 137 Participants |
| Yamagata Strain FluLaval ≥ 65Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | FLO, D21 | 64 Participants |
| Yamagata Strain FluLaval ≥ 65Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | BRI, D0 | 39 Participants |
| Yamagata Strain FluLaval ≥ 65Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H3N1, D0 | 22 Participants |
| Yamagata Strain FluLaval ≥ 65Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H3N1, D21 | 56 Participants |
| Yamagata Strain FluLaval ≥ 65Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | BRI, D21 | 53 Participants |
| Yamagata Strain FluLaval ≥ 65Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H1N1, D21 | 50 Participants |
| Yamagata Strain FluLaval ≥ 65Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | FLO, D0 | 56 Participants |
| Yamagata Strain FluLaval ≥ 65Y Group | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata | H1N1, D0 | 12 Participants |
Secondary
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
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, on subjects for whom results were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2282512A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 8 Participants |
| GSK2282512A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 9 Participants |
| GSK2282512A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 10 Participants |
| GSK2282512A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 260 Participants |
| GSK2282512A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| GSK2282512A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| Victoria Strain FluLaval Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| Victoria Strain FluLaval Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 245 Participants |
| Victoria Strain FluLaval Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| Victoria Strain FluLaval Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 5 Participants |
| Victoria Strain FluLaval Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 11 Participants |
| Victoria Strain FluLaval Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 13 Participants |
| Yamagata Strain FluLaval Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| Yamagata Strain FluLaval Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| Yamagata Strain FluLaval Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 3 Participants |
| Yamagata Strain FluLaval Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 245 Participants |
| Yamagata Strain FluLaval Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 8 Participants |
| Yamagata Strain FluLaval Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 9 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 6 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 93 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 2 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 3 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 3 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 8 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 89 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 3 Participants |
Secondary
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) .
Population: The analysis was performed on the Total Vaccinated cohort, on subjects with available results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2282512A Group | Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) | Subject(s) with Any pIMD(s) | 1 Participants |
| GSK2282512A Group | Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) | Subject(s) with Related pIMD(s) | 0 Participants |
| Victoria Strain FluLaval Group | Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) | Subject(s) with Any pIMD(s) | 1 Participants |
| Victoria Strain FluLaval Group | Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) | Subject(s) with Related pIMD(s) | 0 Participants |
| Yamagata Strain FluLaval Group | Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) | Subject(s) with Any pIMD(s) | 1 Participants |
| Yamagata Strain FluLaval Group | Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) | Subject(s) with Related pIMD(s) | 0 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) | Subject(s) with Related pIMD(s) | 0 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) | Subject(s) with Any pIMD(s) | 0 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) | Subject(s) with Any pIMD(s) | 1 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) | Subject(s) with Related pIMD(s) | 0 Participants |
Secondary
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)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2282512A Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Subject(s) with Related SAE(s) | 0 Participants |
| GSK2282512A Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Subject(s) with Any SAE(s) | 15 Participants |
| Victoria Strain FluLaval Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Subject(s) with Any SAE(s) | 13 Participants |
| Victoria Strain FluLaval Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Subject(s) with Related SAE(s) | 0 Participants |
| Yamagata Strain FluLaval Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Subject(s) with Related SAE(s) | 0 Participants |
| Yamagata Strain FluLaval Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Subject(s) with Any SAE(s) | 7 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Subject(s) with Any SAE(s) | 3 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Subject(s) with Related SAE(s) | 0 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Subject(s) with Any SAE(s) | 7 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Subject(s) with Related SAE(s) | 0 Participants |
Secondary
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
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, on subjects for whom results were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2282512A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 92 Participants |
| GSK2282512A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 6 Participants |
| GSK2282512A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 70 Participants |
| GSK2282512A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint Pain | 1 Participants |
| GSK2282512A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 66 Participants |
| GSK2282512A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering | 39 Participants |
| GSK2282512A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering | 30 Participants |
| GSK2282512A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastr. | 43 Participants |
| GSK2282512A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint Pain | 27 Participants |
| GSK2282512A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle Ache | 113 Participants |
| GSK2282512A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 93 Participants |
| GSK2282512A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering | 4 Participants |
| GSK2282512A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastr. | 34 Participants |
| GSK2282512A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature | 1 Participants |
| GSK2282512A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle Ache | 2 Participants |
| GSK2282512A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature | 3 Participants |
| GSK2282512A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint Pain | 17 Participants |
| GSK2282512A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 4 Participants |
| GSK2282512A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature | 0 Participants |
| GSK2282512A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle Ache | 93 Participants |
| GSK2282512A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastr. | 5 Participants |
| Victoria Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle Ache | 94 Participants |
| Victoria Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature | 8 Participants |
| Victoria Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering | 37 Participants |
| Victoria Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering | 30 Participants |
| Victoria Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering | 2 Participants |
| Victoria Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 72 Participants |
| Victoria Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastr. | 26 Participants |
| Victoria Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastr. | 35 Participants |
| Victoria Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 87 Participants |
| Victoria Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint Pain | 20 Participants |
| Victoria Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 3 Participants |
| Victoria Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint Pain | 3 Participants |
| Victoria Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 60 Participants |
| Victoria Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 2 Participants |
| Victoria Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint Pain | 27 Participants |
| Victoria Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle Ache | 105 Participants |
| Victoria Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 86 Participants |
| Victoria Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature | 8 Participants |
| Victoria Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle Ache | 4 Participants |
| Victoria Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastr. | 1 Participants |
| Victoria Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature | 3 Participants |
| Yamagata Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering | 2 Participants |
| Yamagata Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 93 Participants |
| Yamagata Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 2 Participants |
| Yamagata Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 78 Participants |
| Yamagata Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 91 Participants |
| Yamagata Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 4 Participants |
| Yamagata Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 72 Participants |
| Yamagata Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle Ache | 113 Participants |
| Yamagata Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle Ache | 4 Participants |
| Yamagata Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle Ache | 98 Participants |
| Yamagata Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering | 35 Participants |
| Yamagata Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering | 27 Participants |
| Yamagata Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature | 8 Participants |
| Yamagata Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature | 2 Participants |
| Yamagata Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature | 6 Participants |
| Yamagata Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint Pain | 34 Participants |
| Yamagata Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint Pain | 1 Participants |
| Yamagata Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint Pain | 21 Participants |
| Yamagata Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastr. | 39 Participants |
| Yamagata Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastr. | 4 Participants |
| Yamagata Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastr. | 23 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature | 0 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle Ache | 1 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 41 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 45 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint Pain | 10 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 28 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastr. | 11 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 28 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint Pain | 17 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastr. | 21 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle Ache | 52 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering | 1 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastr. | 4 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 1 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering | 16 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature | 1 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering | 11 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature | 0 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint Pain | 1 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle Ache | 39 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 2 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 4 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature | 3 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle Ache | 3 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature | 1 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle Ache | 40 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature | 2 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 35 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastr. | 1 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint Pain | 15 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 37 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint Pain | 3 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 49 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint Pain | 11 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 32 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastr. | 8 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastr. | 16 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering | 2 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering | 13 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering | 8 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle Ache | 35 Participants |
Secondary
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
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2282512A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Subject(s) with Any Unsolicited AE(s) | 77 Participants |
| GSK2282512A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Subject(s) with Related Unsolicited AE(s) | 18 Participants |
| GSK2282512A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Subject(s) with Grade 3 Unsolicited AE(s) | 5 Participants |
| Victoria Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Subject(s) with Grade 3 Unsolicited AE(s) | 5 Participants |
| Victoria Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Subject(s) with Any Unsolicited AE(s) | 80 Participants |
| Victoria Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Subject(s) with Related Unsolicited AE(s) | 26 Participants |
| Yamagata Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Subject(s) with Grade 3 Unsolicited AE(s) | 15 Participants |
| Yamagata Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Subject(s) with Any Unsolicited AE(s) | 87 Participants |
| Yamagata Strain FluLaval Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Subject(s) with Related Unsolicited AE(s) | 21 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Subject(s) with Any Unsolicited AE(s) | 48 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Subject(s) with Related Unsolicited AE(s) | 11 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Subject(s) with Grade 3 Unsolicited AE(s) | 6 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Subject(s) with Grade 3 Unsolicited AE(s) | 7 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Subject(s) with Any Unsolicited AE(s) | 51 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Subject(s) with Related Unsolicited AE(s) | 13 Participants |
Secondary
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)
Population: The analysis was performed on the Total Vaccinated cohort, on subjects with available results.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2282512A Group | Number of Subjects With Medically-attended Adverse Events (MAEs) | 129 Participants |
| Victoria Strain FluLaval Group | Number of Subjects With Medically-attended Adverse Events (MAEs) | 101 Participants |
| Yamagata Strain FluLaval Group | Number of Subjects With Medically-attended Adverse Events (MAEs) | 100 Participants |
| Victoria Strain FluLaval ≥ 65Y Group | Number of Subjects With Medically-attended Adverse Events (MAEs) | 51 Participants |
| Yamagata Strain FluLaval 18-64Y Group | Number of Subjects With Medically-attended Adverse Events (MAEs) | 64 Participants |
Secondary
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) .
Population: The analysis was performed on the Total Vaccinated cohort, on subjects with available results.
Secondary
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.
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2282512A Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | SCF - H1N1, D21 | 12.1 Titer |
| GSK2282512A Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | SCF - H3N1, D21 | 7.8 Titer |
| GSK2282512A Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | SCF - BRI, D21 | 6.3 Titer |
| GSK2282512A Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | SCF - FLO, D21 | 5.2 Titer |
| Victoria Strain FluLaval Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | SCF - FLO, D21 | 2.6 Titer |
| Victoria Strain FluLaval Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | SCF - H1N1, D21 | 9.2 Titer |
| Victoria Strain FluLaval Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | SCF - BRI, D21 | 4.6 Titer |
| Victoria Strain FluLaval Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | SCF - H3N1, D21 | 10.6 Titer |
| Yamagata Strain FluLaval Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | SCF - FLO, D21 | 4.4 Titer |
| Yamagata Strain FluLaval Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | SCF - H3N1, D21 | 9.5 Titer |
| Yamagata Strain FluLaval Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | SCF - BRI, D21 | 2.7 Titer |
| Yamagata Strain FluLaval Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | SCF - H1N1, D21 | 9.0 Titer |
Secondary
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
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2282512A Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - H1N1, D21 | 15.2 Titer |
| GSK2282512A Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - H3N1, D21 | 8.9 Titer |
| GSK2282512A Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - BRI, D21 | 9.2 Titer |
| GSK2282512A Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - FLO, D21 | 6.7 Titer |
| Victoria Strain FluLaval Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - BRI, D21 | 2.9 Titer |
| Victoria Strain FluLaval Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - H3N1, D21 | 5.9 Titer |
| Victoria Strain FluLaval Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - H1N1, D21 | 7.4 Titer |
| Victoria Strain FluLaval Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - FLO, D21 | 3.1 Titer |
| Yamagata Strain FluLaval Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - FLO, D21 | 3.1 Titer |
| Yamagata Strain FluLaval Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - BRI, D21 | 6.5 Titer |
| Yamagata Strain FluLaval Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - H3N1, D21 | 11.8 Titer |
| Yamagata Strain FluLaval Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - H1N1, D21 | 11.7 Titer |
| Victoria Strain FluLaval ≥ 65Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - H1N1, D21 | 5.8 Titer |
| Victoria Strain FluLaval ≥ 65Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - FLO, D21 | 1.8 Titer |
| Victoria Strain FluLaval ≥ 65Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - H3N1, D21 | 8.6 Titer |
| Victoria Strain FluLaval ≥ 65Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - BRI, D21 | 2.3 Titer |
| Yamagata Strain FluLaval 18-64Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - BRI, D21 | 3.3 Titer |
| Yamagata Strain FluLaval 18-64Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - FLO, D21 | 6.0 Titer |
| Yamagata Strain FluLaval 18-64Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - H3N1, D21 | 11.7 Titer |
| Yamagata Strain FluLaval 18-64Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - H1N1, D21 | 10.5 Titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - H3N1, D21 | 6.0 Titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - BRI, D21 | 1.7 Titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - FLO, D21 | 2.2 Titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - H1N1, D21 | 6.4 Titer |
Secondary
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.
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2282512A Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - H1N1, D21 | 15.8 Titer |
| GSK2282512A Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - H3N1, D21 | 9.1 Titer |
| GSK2282512A Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - BRI, D21 | 9.5 Titer |
| GSK2282512A Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - FLO, D21 | 7.0 Titer |
| Victoria Strain FluLaval Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - BRI, D21 | 3.3 Titer |
| Victoria Strain FluLaval Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - H3N1, D21 | 6.0 Titer |
| Victoria Strain FluLaval Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - H1N1, D21 | 7.7 Titer |
| Victoria Strain FluLaval Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - FLO, D21 | 3.2 Titer |
| Yamagata Strain FluLaval Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - FLO, D21 | 3.2 Titer |
| Yamagata Strain FluLaval Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - BRI, D21 | 6.8 Titer |
| Yamagata Strain FluLaval Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - H3N1, D21 | 12.2 Titer |
| Yamagata Strain FluLaval Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - H1N1, D21 | 12.0 Titer |
| Victoria Strain FluLaval ≥ 65Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - H1N1, D21 | 6.0 Titer |
| Victoria Strain FluLaval ≥ 65Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - FLO, D21 | 1.9 Titer |
| Victoria Strain FluLaval ≥ 65Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - H3N1, D21 | 8.5 Titer |
| Victoria Strain FluLaval ≥ 65Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - BRI, D21 | 2.4 Titer |
| Yamagata Strain FluLaval 18-64Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - BRI, D21 | 3.4 Titer |
| Yamagata Strain FluLaval 18-64Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - FLO, D21 | 6.3 Titer |
| Yamagata Strain FluLaval 18-64Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - H3N1, D21 | 12.0 Titer |
| Yamagata Strain FluLaval 18-64Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - H1N1, D21 | 11.0 Titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - H3N1, D21 | 6.2 Titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - BRI, D21 | 1.8 Titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - FLO, D21 | 2.3 Titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | SCF - H1N1, D21 | 6.2 Titer |
Secondary
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.
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all vaccinated subjects who had not received a vaccine forbidden in the protocol, and with available assay results at Day 180 for assessed antibodies.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H1N1, D0 | 16.4 Titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H1N1, D21 | 173.5 Titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H1N1, D180 | 51.7 Titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H3N1, D0 | 16.7 Titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H3N1, D21 | 121.4 Titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H3N1, D180 | 42.1 Titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | BRI, D0 | 31.1 Titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | BRI, D21 | 179.0 Titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | BRI, D180 | 120.1 Titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | FLO, D0 | 77.3 Titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | FLO, D21 | 399.2 Titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | FLO, D180 | 253.1 Titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | FLO, D180 | 167.8 Titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H1N1, D0 | 20.4 Titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | BRI, D0 | 36.8 Titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | BRI, D180 | 114.2 Titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H1N1, D21 | 211.9 Titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H3N1, D180 | 46.4 Titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | FLO, D21 | 194.8 Titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H1N1, D180 | 74.2 Titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | BRI, D21 | 137.7 Titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H3N1, D21 | 166.0 Titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H3N1, D0 | 14.4 Titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | FLO, D0 | 92.9 Titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H3N1, D0 | 14.6 Titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H3N1, D21 | 166.7 Titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | FLO, D0 | 68.4 Titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H3N1, D180 | 61.9 Titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | BRI, D0 | 23.8 Titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | BRI, D21 | 62.9 Titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | FLO, D21 | 275.8 Titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H1N1, D0 | 13.7 Titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H1N1, D21 | 126.0 Titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | BRI, D180 | 68.4 Titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | H1N1, D180 | 45.3 Titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease | FLO, D180 | 239.6 Titer |
Secondary
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.
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D0 | 15.4 titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D21 | 306.9 titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D0 | 19.5 titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D21 | 141.0 titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D0 | 21.6 titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D21 | 204.8 titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D0 | 70.5 titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D21 | 493.1 titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D21 | 102.9 titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D21 | 281.4 titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D0 | 13.4 titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D0 | 86.7 titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D21 | 140.1 titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D0 | 17.1 titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D21 | 103.8 titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D0 | 42.8 titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D21 | 248.3 titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D0 | 15.4 titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D21 | 187.0 titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D21 | 211.4 titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D0 | 23.9 titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D21 | 164.4 titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D0 | 66.4 titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D0 | 20.7 titer |
| Victoria Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D0 | 70.8 titer |
| Victoria Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D21 | 99.3 titer |
| Victoria Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D0 | 41.3 titer |
| Victoria Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D0 | 16.6 titer |
| Victoria Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D0 | 11.8 titer |
| Victoria Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D21 | 99.7 titer |
| Victoria Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D21 | 131.9 titer |
| Victoria Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D21 | 99.7 titer |
| Yamagata Strain FluLaval 18-64Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D21 | 413.7 titer |
| Yamagata Strain FluLaval 18-64Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D0 | 19.3 titer |
| Yamagata Strain FluLaval 18-64Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D0 | 21.6 titer |
| Yamagata Strain FluLaval 18-64Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D21 | 73.3 titer |
| Yamagata Strain FluLaval 18-64Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D0 | 64.3 titer |
| Yamagata Strain FluLaval 18-64Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D21 | 212.2 titer |
| Yamagata Strain FluLaval 18-64Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D0 | 14.8 titer |
| Yamagata Strain FluLaval 18-64Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D21 | 178.2 titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D21 | 180.2 titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D0 | 38.9 titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D0 | 15.0 titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D21 | 93.0 titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D21 | 69.3 titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D21 | 78.9 titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D0 | 80.0 titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D0 | 12.5 titer |
Secondary
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.
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D0 | 15.2 titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D21 | 289.4 titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D0 | 19.0 titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D21 | 136.1 titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D0 | 21.7 titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D21 | 199.3 titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D0 | 70.7 titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D21 | 475.3 titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D21 | 105.1 titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D21 | 276.1 titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D0 | 13.2 titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D0 | 89.1 titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D21 | 139.0 titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D0 | 17.8 titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D21 | 97.4 titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D0 | 47.9 titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D21 | 236.9 titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D0 | 15.0 titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D21 | 176.3 titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D21 | 204.9 titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D0 | 23.8 titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D21 | 157.2 titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D0 | 66.1 titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D0 | 20.3 titer |
| Victoria Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D0 | 72.2 titer |
| Victoria Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D21 | 101.6 titer |
| Victoria Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D0 | 44.7 titer |
| Victoria Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D0 | 16.8 titer |
| Victoria Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D0 | 12.0 titer |
| Victoria Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D21 | 103.2 titer |
| Victoria Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D21 | 131.8 titer |
| Victoria Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D21 | 97.1 titer |
| Yamagata Strain FluLaval 18-64Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D21 | 406.1 titer |
| Yamagata Strain FluLaval 18-64Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D0 | 18.7 titer |
| Yamagata Strain FluLaval 18-64Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D0 | 22.8 titer |
| Yamagata Strain FluLaval 18-64Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D21 | 75.1 titer |
| Yamagata Strain FluLaval 18-64Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D0 | 67.6 titer |
| Yamagata Strain FluLaval 18-64Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D21 | 198.5 titer |
| Yamagata Strain FluLaval 18-64Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D0 | 14.8 titer |
| Yamagata Strain FluLaval 18-64Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D21 | 173.6 titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D21 | 167.7 titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D0 | 37.6 titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D0 | 15.1 titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D21 | 90.1 titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D21 | 65.4 titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D21 | 80.8 titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D0 | 76.3 titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D0 | 12.6 titer |
Secondary
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.
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all vaccinated subjects who had not received a vaccine forbidden in the protocol, and with available assay results at Day 180 for assessed antibodies.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D180 | 111.1 Titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D0 | 22.7 Titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D21 | 183.6 Titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D180 | 314.1 Titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D180 | 95.5 Titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D21 | 473.4 Titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D0 | 15.3 Titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D21 | 115.0 Titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D0 | 78.5 Titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D180 | 41.3 Titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D21 | 293.3 Titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D0 | 23.1 Titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D180 | 43.1 Titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D0 | 42.5 Titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D180 | 130.2 Titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D21 | 100.5 Titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D21 | 128.6 Titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D0 | 18.4 Titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D0 | 11.6 Titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D21 | 174.3 Titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D21 | 334.4 Titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D180 | 27.4 Titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D180 | 202.1 Titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D0 | 76.1 Titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D21 | 209.5 Titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D180 | 98.8 Titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D180 | 124.6 Titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D0 | 13.3 Titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D180 | 190.4 Titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D0 | 98.9 Titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D0 | 29.9 Titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D21 | 166.4 Titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D21 | 163.1 Titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D21 | 339.0 Titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D0 | 23.3 Titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D180 | 49.4 Titer |
| Victoria Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D21 | 115.2 Titer |
| Victoria Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D0 | 17.9 Titer |
| Victoria Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D21 | 135.7 Titer |
| Victoria Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D180 | 56.6 Titer |
| Victoria Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D0 | 15.5 Titer |
| Victoria Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D21 | 168.9 Titer |
| Victoria Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D180 | 43.8 Titer |
| Victoria Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D0 | 44.6 Titer |
| Victoria Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D180 | 105.2 Titer |
| Victoria Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D0 | 87.6 Titer |
| Victoria Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D21 | 181.7 Titer |
| Victoria Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D180 | 148.8 Titer |
| Yamagata Strain FluLaval 18-64Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D21 | 175.1 Titer |
| Yamagata Strain FluLaval 18-64Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D180 | 56.6 Titer |
| Yamagata Strain FluLaval 18-64Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D0 | 18.0 Titer |
| Yamagata Strain FluLaval 18-64Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D180 | 329.9 Titer |
| Yamagata Strain FluLaval 18-64Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D21 | 401.2 Titer |
| Yamagata Strain FluLaval 18-64Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D0 | 12.2 Titer |
| Yamagata Strain FluLaval 18-64Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D21 | 180.6 Titer |
| Yamagata Strain FluLaval 18-64Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D180 | 63.8 Titer |
| Yamagata Strain FluLaval 18-64Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D0 | 64.8 Titer |
| Yamagata Strain FluLaval 18-64Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D0 | 19.7 Titer |
| Yamagata Strain FluLaval 18-64Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D21 | 56.5 Titer |
| Yamagata Strain FluLaval 18-64Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D180 | 61.9 Titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D21 | 71.8 Titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D21 | 157.1 Titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D180 | 74.3 Titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D0 | 18.2 Titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D180 | 162.8 Titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D0 | 73.0 Titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D180 | 34.5 Titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D21 | 81.5 Titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D21 | 175.3 Titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D0 | 9.8 Titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D0 | 29.9 Titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D180 | 61.9 Titer |
Secondary
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.
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all vaccinated subjects who had not received a vaccine forbidden in the protocol with available assay results for assessed antibodies in Day 180 blood samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D180 | 112.8 titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D0 | 23.1 titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D21 | 193.0 titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D180 | 311.9 titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D180 | 97.9 titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D21 | 485.8 titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D0 | 15.5 titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D21 | 123.2 titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D0 | 75.4 titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D180 | 40.9 titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D21 | 302.4 titer |
| GSK2282512A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D0 | 22.9 titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D180 | 43.3 titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D0 | 41.1 titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D180 | 127.0 titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D21 | 105.0 titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D21 | 119.8 titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D0 | 17.9 titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D0 | 12.0 titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D21 | 167.2 titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D21 | 334.3 titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D180 | 29.1 titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D180 | 209.5 titer |
| Victoria Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D0 | 79.2 titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D21 | 204.4 titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D180 | 104.2 titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D180 | 130.5 titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D0 | 12.0 titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D180 | 177.3 titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D0 | 92.3 titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D0 | 30.7 titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D21 | 180.9 titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D21 | 163.3 titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D21 | 369.1 titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D0 | 22.6 titer |
| Yamagata Strain FluLaval Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D180 | 46.1 titer |
| Victoria Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D21 | 109.3 titer |
| Victoria Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D0 | 18.7 titer |
| Victoria Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D21 | 132.2 titer |
| Victoria Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D180 | 55.6 titer |
| Victoria Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D0 | 16.8 titer |
| Victoria Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D21 | 168.4 titer |
| Victoria Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D180 | 46.7 titer |
| Victoria Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D0 | 42.9 titer |
| Victoria Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D180 | 102.0 titer |
| Victoria Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D0 | 93.5 titer |
| Victoria Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D21 | 187.0 titer |
| Victoria Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D180 | 160.1 titer |
| Yamagata Strain FluLaval 18-64Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D21 | 175.9 titer |
| Yamagata Strain FluLaval 18-64Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D180 | 57.5 titer |
| Yamagata Strain FluLaval 18-64Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D0 | 17.9 titer |
| Yamagata Strain FluLaval 18-64Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D180 | 320.1 titer |
| Yamagata Strain FluLaval 18-64Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D21 | 405.3 titer |
| Yamagata Strain FluLaval 18-64Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D0 | 12.7 titer |
| Yamagata Strain FluLaval 18-64Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D21 | 187.4 titer |
| Yamagata Strain FluLaval 18-64Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D180 | 59.3 titer |
| Yamagata Strain FluLaval 18-64Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D0 | 60.3 titer |
| Yamagata Strain FluLaval 18-64Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D0 | 17.9 titer |
| Yamagata Strain FluLaval 18-64Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D21 | 53.9 titer |
| Yamagata Strain FluLaval 18-64Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D180 | 63.0 titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D21 | 74.7 titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D21 | 157.2 titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D180 | 79.9 titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D0 | 17.1 titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D180 | 174.3 titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D0 | 78.6 titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D180 | 34.8 titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D21 | 81.4 titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | FLO, D21 | 180.6 titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H1N1, D0 | 10.2 titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | BRI, D0 | 32.5 titer |
| Yamagata Strain FluLaval ≥ 65Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata | H3N1, D180 | 60.6 titer |