Influenza
Conditions
Keywords
Influenza, Influenza Vaccine
Brief summary
In order to find the formulation leading to a maximal increase of the immune response while maintaining an acceptable safety profile, this study is designed to evaluate the immunogenicity, safety and reactogenicity of the different formulations of GSK Biologicals' influenza vaccine administered in adults aged 18-64 years.
Detailed description
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Interventions
BIOLOGICALInfluenza Vaccine GSK1247446A - 4 different formulations
Single dose, Intramuscular injection
BIOLOGICALFluarix™
Single dose, Intramuscular injection
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Only subjects who the investigator believes that they can and will comply with the requirements of the protocol . * A male or female between, and including, 18 - 64 years of age at the time of vaccination. * Written informed consent obtained from the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study. * If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must have a negative pregnancy test, practice adequate contraception for 30 days prior to vaccination, and continue such precautions for 2 months after completion of the vaccination series.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose * Administration of a vaccine not foreseen by the study protocol from 30 days before vaccination, up to 21 days after vaccination. * History of hypersensitivity to a previous dose of influenza vaccine. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s) * Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * Confirmed influenza infection within a year preceding the study start. * Administration of an influenza vaccine within a year preceding the study start. * Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. * Pregnant or lactating female. * Concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product * Acute disease at the time of enrolment. * History of chronic alcohol consumption and/or drug abuse. * Female planning to become pregnant or planning to discontinue contraceptive precautions. * Any condition which, in the opinion of the investigator, prevents the subject from participating in the study. * History of administration of experimental/licensed vaccine containing squalene and/or tocopherol within the last 12 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | At Days 0, 21 and 180 | Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA). The seropositivity cut-off assay was 1:10. The results for Day 0 and Day 21 are the primary efficacy variables. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | At Days 21 and 180 | 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. The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA). |
| Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | At Days 0, 21 and 180 | A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA). |
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | At Days 0 and 21 | Titers are presented as geometric mean titers (GMTs). The 4 influenza strains assessed were A/Wisconsin (WISC), B/Malaysia (MALA), A/Brisbane (BRIS) and B/Florida (FLOR). The seropositivity cut-off assay was 1:28. |
| Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | At Days 0, 21 and 180 | The mean was calculated for CD4 T-cells (per million CD4 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-γ), at least IL2 and at least TNF alpha (TNF-α). |
| Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | At Days 0, 21 and 180 | The mean was calculated for CD8 T-cells (per million CD8 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-γ), at least IL2 and at least TNF alpha (TNF-α). |
| Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | At Days 21 and 180 | 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 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA). |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | During the 7-day (Days 0-6) post vaccination period | Assessed solicited general symptoms were arthralgia, fatigue, fever \[oral temperature above (\>) 38.0 degrees Celsius (°C)\], headache, myalgia, nausea and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination. |
| Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs). | From Day 0 to Day 180 | MSCs were defined as conditions prompting emergency room visits or physician visits that were not related to common diseases or routine visits. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 = event which prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | During the 21-day (Days 0-20) post vaccination period | 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 activity Related = unsolicited AE assessed by the investigator as related to the vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs). | 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 Subjects With Any and Grade 3 Solicited Local Symptoms. | During the 7-day (Days 0-6) post vaccination period | Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. |
Countries
France, Germany, Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GSK1247446A 1 Group Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | 200 |
| GSK1247446A 2 Group Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | 198 |
| GSK1247446A 3 Group Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | 204 |
| GSK1247446A 4 Group Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | 202 |
| Fluarix Group Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | 202 |
| Total | 1,006 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | GSK1247446A 1 Group | GSK1247446A 2 Group | GSK1247446A 3 Group | GSK1247446A 4 Group | Fluarix Group | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 40.5 Years STANDARD_DEVIATION 14.14 | 40.3 Years STANDARD_DEVIATION 13.79 | 39.7 Years STANDARD_DEVIATION 14.37 | 39.7 Years STANDARD_DEVIATION 14.31 | 40.1 Years STANDARD_DEVIATION 14.11 | 40.1 Years STANDARD_DEVIATION 14.14 |
| Sex: Female, Male Female | 115 Participants | 116 Participants | 115 Participants | 140 Participants | 123 Participants | 609 Participants |
| Sex: Female, Male Male | 85 Participants | 82 Participants | 89 Participants | 62 Participants | 79 Participants | 397 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 | 1 / 200 | 0 / 198 | 0 / 204 | 0 / 202 | 0 / 202 |
| other Total, other adverse events | 182 / 200 | 175 / 198 | 167 / 204 | 151 / 202 | 121 / 202 |
| serious Total, serious adverse events | 7 / 200 | 3 / 198 | 3 / 204 | 4 / 202 | 2 / 202 |
Outcome results
Primary
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA). The seropositivity cut-off assay was 1:10. The results for Day 0 and Day 21 are the primary efficacy variables.
Time frame: At Days 0, 21 and 180
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable 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) |
|---|---|---|---|
| GSK1247446A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | MALA, Day 180 [N=189;190;192;192;187] | 106.6 titers |
| GSK1247446A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | WISC, Day 21 [N=187;189;190;192;185] | 380.1 titers |
| GSK1247446A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | SOLO, Day 21 [N=187;189;190;192;185] | 203.2 titers |
| GSK1247446A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | WISC, Day 180 [N=189;190;192;192;187] | 174.3 titers |
| GSK1247446A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | MALA, Day 21 [N=187;189;190;192;185] | 225.8 titers |
| GSK1247446A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | SOLO, Day 180 [N=189;190;192;192;187] | 81.3 titers |
| GSK1247446A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | MALA, Day 0 [N=187;189;190;192;185] | 25.8 titers |
| GSK1247446A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | WISC, Day 0 [N=187;189;190;192;185] | 29.4 titers |
| GSK1247446A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | SOLO, Day 0 [N=187;189;190;192;185] | 13.0 titers |
| GSK1247446A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | MALA, Day 0 [N=187;189;190;192;185] | 27.3 titers |
| GSK1247446A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | WISC, Day 180 [N=189;190;192;192;187] | 149.5 titers |
| GSK1247446A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | WISC, Day 0 [N=187;189;190;192;185] | 30.0 titers |
| GSK1247446A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | WISC, Day 21 [N=187;189;190;192;185] | 326.4 titers |
| GSK1247446A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | SOLO, Day 180 [N=189;190;192;192;187] | 71.1 titers |
| GSK1247446A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | MALA, Day 180 [N=189;190;192;192;187] | 119.6 titers |
| GSK1247446A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | SOLO, Day 21 [N=187;189;190;192;185] | 155.8 titers |
| GSK1247446A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | SOLO, Day 0 [N=187;189;190;192;185] | 12.3 titers |
| GSK1247446A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | MALA, Day 21 [N=187;189;190;192;185] | 246.1 titers |
| GSK1247446A 3 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | WISC, Day 180 [N=189;190;192;192;187] | 164.0 titers |
| GSK1247446A 3 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | SOLO, Day 0 [N=187;189;190;192;185] | 12.9 titers |
| GSK1247446A 3 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | SOLO, Day 21 [N=187;189;190;192;185] | 164.9 titers |
| GSK1247446A 3 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | SOLO, Day 180 [N=189;190;192;192;187] | 76.3 titers |
| GSK1247446A 3 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | WISC, Day 0 [N=187;189;190;192;185] | 29.9 titers |
| GSK1247446A 3 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | WISC, Day 21 [N=187;189;190;192;185] | 319.9 titers |
| GSK1247446A 3 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | MALA, Day 0 [N=187;189;190;192;185] | 22.6 titers |
| GSK1247446A 3 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | MALA, Day 21 [N=187;189;190;192;185] | 195.5 titers |
| GSK1247446A 3 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | MALA, Day 180 [N=189;190;192;192;187] | 97.2 titers |
| GSK1247446A 4 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | WISC, Day 0 [N=187;189;190;192;185] | 27.2 titers |
| GSK1247446A 4 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | WISC, Day 180 [N=189;190;192;192;187] | 133.0 titers |
| GSK1247446A 4 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | SOLO, Day 180 [N=189;190;192;192;187] | 80.7 titers |
| GSK1247446A 4 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | MALA, Day 0 [N=187;189;190;192;185] | 23.2 titers |
| GSK1247446A 4 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | SOLO, Day 21 [N=187;189;190;192;185] | 151.1 titers |
| GSK1247446A 4 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | MALA, Day 180 [N=189;190;192;192;187] | 95.7 titers |
| GSK1247446A 4 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | MALA, Day 21 [N=187;189;190;192;185] | 171.2 titers |
| GSK1247446A 4 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | SOLO, Day 0 [N=187;189;190;192;185] | 14.9 titers |
| GSK1247446A 4 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | WISC, Day 21 [N=187;189;190;192;185] | 273.9 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | SOLO, Day 0 [N=187;189;190;192;185] | 15.1 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | WISC, Day 0 [N=187;189;190;192;185] | 37.4 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | WISC, Day 180 [N=189;190;192;192;187] | 176.2 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | SOLO, Day 180 [N=189;190;192;192;187] | 97.6 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | WISC, Day 21 [N=187;189;190;192;185] | 335.3 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | MALA, Day 180 [N=189;190;192;192;187] | 108.8 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | MALA, Day 21 [N=187;189;190;192;185] | 217.8 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | MALA, Day 0 [N=187;189;190;192;185] | 27.0 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | SOLO, Day 21 [N=187;189;190;192;185] | 191.0 titers |
Secondary
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
The mean was calculated for CD4 T-cells (per million CD4 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-γ), at least IL2 and at least TNF alpha (TNF-α).
Time frame: At Days 0, 21 and 180
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable 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 (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1247446A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IL2, Day 0 [N=45;47;43;47;39] | 1684.24 cells | Standard Deviation 983.48 |
| GSK1247446A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IFN-γ, Day 180 [N=46;42;42;43;41] | 1792.74 cells | Standard Deviation 1075.76 |
| GSK1247446A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IFN-γ, Day 21 [N=45;45;40;45;39] | 2525.91 cells | Standard Deviation 1615.78 |
| GSK1247446A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | All Doubles, Day 0 [N=45;47;43;47;39] | 2106.16 cells | Standard Deviation 1274.9 |
| GSK1247446A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | TNF-α, Day 21 [N=45;45;40;45;39] | 2767.02 cells | Standard Deviation 1598.41 |
| GSK1247446A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | All Doubles, Day 180 [N=46;42;42;43;41] | 2628.96 cells | Standard Deviation 1353.46 |
| GSK1247446A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | TNF-α, Day 0 [N=45;47;43;47;39] | 1606.64 cells | Standard Deviation 1087.17 |
| GSK1247446A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | CD40L, Day 0 [N=45;47;43;47;39] | 1914.96 cells | Standard Deviation 1241.38 |
| GSK1247446A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | TNF-α, Day 180 [N=46;42;42;43;41] | 1980.39 cells | Standard Deviation 1078.92 |
| GSK1247446A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IL2, Day 180 [N=46;42;42;43;41] | 2121.67 cells | Standard Deviation 1088.48 |
| GSK1247446A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | CD40L, Day 21 [N=45;45;40;45;39] | 3337.89 cells | Standard Deviation 1982.59 |
| GSK1247446A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | All Doubles, Day 21 [N=45;45;40;45;39] | 3857.76 cells | Standard Deviation 2195.47 |
| GSK1247446A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IL2, Day 21 [N=45;45;40;45;39] | 3020.09 cells | Standard Deviation 1741.78 |
| GSK1247446A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | CD40L, Day 180 [N=46;42;42;43;41] | 2108.04 cells | Standard Deviation 1190.42 |
| GSK1247446A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IFN-γ, Day 0 [N=45;47;43;47;39] | 1379.33 cells | Standard Deviation 987.07 |
| GSK1247446A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | CD40L, Day 180 [N=46;42;42;43;41] | 1758.95 cells | Standard Deviation 1093.8 |
| GSK1247446A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IFN-γ, Day 0 [N=45;47;43;47;39] | 1377.13 cells | Standard Deviation 741.31 |
| GSK1247446A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | All Doubles, Day 0 [N=45;47;43;47;39] | 2043.17 cells | Standard Deviation 894.18 |
| GSK1247446A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IFN-γ, Day 180 [N=46;42;42;43;41] | 1546.55 cells | Standard Deviation 1055.94 |
| GSK1247446A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | CD40L, Day 0 [N=45;47;43;47;39] | 1863.96 cells | Standard Deviation 830.55 |
| GSK1247446A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IL2, Day 21 [N=45;45;40;45;39] | 2634.64 cells | Standard Deviation 1415.24 |
| GSK1247446A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IFN-γ, Day 21 [N=45;45;40;45;39] | 2233.24 cells | Standard Deviation 1371.05 |
| GSK1247446A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IL2, Day 180 [N=46;42;42;43;41] | 1816.26 cells | Standard Deviation 1116.55 |
| GSK1247446A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | TNF-α, Day 21 [N=45;45;40;45;39] | 2337.38 cells | Standard Deviation 1068.82 |
| GSK1247446A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | All Doubles, Day 21 [N=45;45;40;45;39] | 3366.93 cells | Standard Deviation 1693.4 |
| GSK1247446A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IL2, Day 0 [N=45;47;43;47;39] | 1657.28 cells | Standard Deviation 744.17 |
| GSK1247446A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | All Doubles, Day 180 [N=46;42;42;43;41] | 2249.88 cells | Standard Deviation 1325.73 |
| GSK1247446A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | TNF-α, Day 180 [N=46;42;42;43;41] | 1654.90 cells | Standard Deviation 944.9 |
| GSK1247446A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | TNF-α, Day 0 [N=45;47;43;47;39] | 1522.70 cells | Standard Deviation 747.67 |
| GSK1247446A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | CD40L, Day 21 [N=45;45;40;45;39] | 2947.20 cells | Standard Deviation 1487.13 |
| GSK1247446A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IFN-γ, Day 21 [N=45;45;40;45;39] | 2056.40 cells | Standard Deviation 1205.9 |
| GSK1247446A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | All Doubles, Day 0 [N=45;47;43;47;39] | 2252.44 cells | Standard Deviation 1726.88 |
| GSK1247446A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | All Doubles, Day 21 [N=45;45;40;45;39] | 3103.30 cells | Standard Deviation 1549.21 |
| GSK1247446A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | All Doubles, Day 180 [N=46;42;42;43;41] | 1963.38 cells | Standard Deviation 1245.21 |
| GSK1247446A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | CD40L, Day 0 [N=45;47;43;47;39] | 2045.86 cells | Standard Deviation 1638.11 |
| GSK1247446A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | CD40L, Day 21 [N=45;45;40;45;39] | 2624.30 cells | Standard Deviation 1316.6 |
| GSK1247446A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | CD40L, Day 180 [N=46;42;42;43;41] | 1581.31 cells | Standard Deviation 1184.99 |
| GSK1247446A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IFN-γ, Day 0 [N=45;47;43;47;39] | 1510.84 cells | Standard Deviation 1349.58 |
| GSK1247446A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IFN-γ, Day 180 [N=46;42;42;43;41] | 1335.62 cells | Standard Deviation 970.49 |
| GSK1247446A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IL2, Day 0 [N=45;47;43;47;39] | 1796.33 cells | Standard Deviation 1354.89 |
| GSK1247446A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IL2, Day 21 [N=45;45;40;45;39] | 2343.15 cells | Standard Deviation 1199.2 |
| GSK1247446A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IL2, Day 180 [N=46;42;42;43;41] | 1571.19 cells | Standard Deviation 987.96 |
| GSK1247446A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | TNF-α, Day 0 [N=45;47;43;47;39] | 1712.42 cells | Standard Deviation 1355.23 |
| GSK1247446A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | TNF-α, Day 21 [N=45;45;40;45;39] | 2109.45 cells | Standard Deviation 1075.51 |
| GSK1247446A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | TNF-α, Day 180 [N=46;42;42;43;41] | 1454.40 cells | Standard Deviation 898.01 |
| GSK1247446A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IL2, Day 21 [N=45;45;40;45;39] | 2256.02 cells | Standard Deviation 1251.58 |
| GSK1247446A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | All Doubles, Day 180 [N=46;42;42;43;41] | 2153.12 cells | Standard Deviation 1473.45 |
| GSK1247446A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IL2, Day 0 [N=45;47;43;47;39] | 1732.91 cells | Standard Deviation 1140.54 |
| GSK1247446A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | TNF-α, Day 0 [N=45;47;43;47;39] | 1548.00 cells | Standard Deviation 1094.03 |
| GSK1247446A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | CD40L, Day 21 [N=45;45;40;45;39] | 2472.98 cells | Standard Deviation 1378.17 |
| GSK1247446A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | CD40L, Day 0 [N=45;47;43;47;39] | 1954.13 cells | Standard Deviation 1290.77 |
| GSK1247446A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | All Doubles, Day 21 [N=45;45;40;45;39] | 2827.84 cells | Standard Deviation 1561.6 |
| GSK1247446A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | TNF-α, Day 180 [N=46;42;42;43;41] | 1627.67 cells | Standard Deviation 1155.63 |
| GSK1247446A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IFN-γ, Day 21 [N=45;45;40;45;39] | 1824.69 cells | Standard Deviation 1265.29 |
| GSK1247446A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | All Doubles, Day 0 [N=45;47;43;47;39] | 2103.66 cells | Standard Deviation 1370.89 |
| GSK1247446A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IL2, Day 180 [N=46;42;42;43;41] | 1797.79 cells | Standard Deviation 1228.49 |
| GSK1247446A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IFN-γ, Day 0 [N=45;47;43;47;39] | 1342.57 cells | Standard Deviation 1040.63 |
| GSK1247446A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | TNF-α, Day 21 [N=45;45;40;45;39] | 1990.60 cells | Standard Deviation 1157.58 |
| GSK1247446A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IFN-γ, Day 180 [N=46;42;42;43;41] | 1440.09 cells | Standard Deviation 1199.84 |
| GSK1247446A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | CD40L, Day 180 [N=46;42;42;43;41] | 1731.00 cells | Standard Deviation 1331.05 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IFN-γ, Day 180 [N=46;42;42;43;41] | 1299.95 cells | Standard Deviation 894.25 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | TNF-α, Day 21 [N=45;45;40;45;39] | 1639.31 cells | Standard Deviation 975.93 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IL2, Day 0 [N=45;47;43;47;39] | 1572.69 cells | Standard Deviation 812.49 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | CD40L, Day 21 [N=45;45;40;45;39] | 2223.74 cells | Standard Deviation 1398.63 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | All Doubles, Day 0 [N=45;47;43;47;39] | 1976.23 cells | Standard Deviation 1051.16 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IL2, Day 21 [N=45;45;40;45;39] | 1933.10 cells | Standard Deviation 1153.35 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | CD40L, Day 0 [N=45;47;43;47;39] | 1827.67 cells | Standard Deviation 1033.38 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IL2, Day 180 [N=46;42;42;43;41] | 1581.73 cells | Standard Deviation 1028.49 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | All Doubles, Day 180 [N=46;42;42;43;41] | 1952.02 cells | Standard Deviation 1240.63 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | TNF-α, Day 180 [N=46;42;42;43;41] | 1392.05 cells | Standard Deviation 933.32 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | TNF-α, Day 0 [N=45;47;43;47;39] | 1421.82 cells | Standard Deviation 781.48 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | All Doubles, Day 21 [N=45;45;40;45;39] | 2489.15 cells | Standard Deviation 1468.71 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IFN-γ, Day 21 [N=45;45;40;45;39] | 1565.79 cells | Standard Deviation 1064.31 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IFN-γ, Day 0 [N=45;47;43;47;39] | 1260.97 cells | Standard Deviation 809.24 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | CD40L, Day 180 [N=46;42;42;43;41] | 1560.76 cells | Standard Deviation 1009.77 |
Secondary
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
The mean was calculated for CD8 T-cells (per million CD8 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-γ), at least IL2 and at least TNF alpha (TNF-α).
Time frame: At Days 0, 21 and 180
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable 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 (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1247446A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IL2, Day 0 [N=44;46;43;45;39] | 35.59 cells | Standard Deviation 91.49 |
| GSK1247446A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IFN-γ, Day 180 [N=44;40;42;41;41] | 38.18 cells | Standard Deviation 50.84 |
| GSK1247446A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IFN-γ, Day 21 [N=44;43;40;42;38] | 24.86 cells | Standard Deviation 61.18 |
| GSK1247446A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | All Doubles, Day 0 [N=44;46;43;45;39] | 50.02 cells | Standard Deviation 113.85 |
| GSK1247446A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | TNF-α, Day 21 [N=44;43;40;42;38] | 37.93 cells | Standard Deviation 109.46 |
| GSK1247446A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | All Doubles, Day 180 [N=44;40;42;41;41] | 44.32 cells | Standard Deviation 99.11 |
| GSK1247446A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | TNF-α, Day 0 [N=44;46;43;45;39] | 42.98 cells | Standard Deviation 109.79 |
| GSK1247446A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | CD40L, Day 0 [N=44;46;43;45;39] | 3.64 cells | Standard Deviation 12.37 |
| GSK1247446A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | TNF-α, Day 180 [N=44;40;42;41;41] | 34.70 cells | Standard Deviation 86.94 |
| GSK1247446A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IL2, Day 180 [N=44;40;42;41;41] | 27.36 cells | Standard Deviation 87.59 |
| GSK1247446A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | CD40L, Day 21 [N=44;43;40;42;38] | 8.82 cells | Standard Deviation 28.38 |
| GSK1247446A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | All Doubles, Day 21 [N=44;43;40;42;38] | 47.18 cells | Standard Deviation 106.55 |
| GSK1247446A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IL2, Day 21 [N=44;46;43;45;39] | 36.98 cells | Standard Deviation 85.05 |
| GSK1247446A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | CD40L, Day 180 [N=44;40;42;41;41] | 9.45 cells | Standard Deviation 35.59 |
| GSK1247446A 1 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IFN-γ, Day 0 [N=44;46;43;45;39] | 29.50 cells | Standard Deviation 53.27 |
| GSK1247446A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | CD40L, Day 180 [N=44;40;42;41;41] | 15.88 cells | Standard Deviation 61.59 |
| GSK1247446A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IFN-γ, Day 0 [N=44;46;43;45;39] | 96.91 cells | Standard Deviation 375.61 |
| GSK1247446A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | All Doubles, Day 0 [N=44;46;43;45;39] | 109.63 cells | Standard Deviation 405.09 |
| GSK1247446A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IFN-γ, Day 180 [N=44;40;42;41;41] | 110.75 cells | Standard Deviation 303.91 |
| GSK1247446A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | CD40L, Day 0 [N=44;46;43;45;39] | 5.91 cells | Standard Deviation 15.92 |
| GSK1247446A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IL2, Day 21 [N=44;46;43;45;39] | 21.51 cells | Standard Deviation 42.47 |
| GSK1247446A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IFN-γ, Day 21 [N=44;43;40;42;38] | 48.07 cells | Standard Deviation 106.65 |
| GSK1247446A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IL2, Day 180 [N=44;40;42;41;41] | 74.03 cells | Standard Deviation 183.59 |
| GSK1247446A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | TNF-α, Day 21 [N=44;43;40;42;38] | 44.16 cells | Standard Deviation 99.17 |
| GSK1247446A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | All Doubles, Day 21 [N=44;43;40;42;38] | 50.09 cells | Standard Deviation 101.55 |
| GSK1247446A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IL2, Day 0 [N=44;46;43;45;39] | 75.41 cells | Standard Deviation 309.22 |
| GSK1247446A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | All Doubles, Day 180 [N=44;40;42;41;41] | 126.13 cells | Standard Deviation 323.68 |
| GSK1247446A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | TNF-α, Day 180 [N=44;40;42;41;41] | 111.10 cells | Standard Deviation 299.67 |
| GSK1247446A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | TNF-α, Day 0 [N=44;46;43;45;39] | 102.72 cells | Standard Deviation 391.96 |
| GSK1247446A 2 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | CD40L, Day 21 [N=44;43;40;42;38] | 10.09 cells | Standard Deviation 21.58 |
| GSK1247446A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IFN-γ, Day 21 [N=44;43;40;42;38] | 25.65 cells | Standard Deviation 49.98 |
| GSK1247446A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | All Doubles, Day 0 [N=44;46;43;45;39] | 17.33 cells | Standard Deviation 33.12 |
| GSK1247446A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | All Doubles, Day 21 [N=44;43;40;42;38] | 38.53 cells | Standard Deviation 67.21 |
| GSK1247446A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | All Doubles, Day 180 [N=44;40;42;41;41] | 36.31 cells | Standard Deviation 95.06 |
| GSK1247446A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | CD40L, Day 0 [N=44;46;43;45;39] | 2.63 cells | Standard Deviation 8.06 |
| GSK1247446A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | CD40L, Day 21 [N=44;43;40;42;38] | 6.45 cells | Standard Deviation 16.03 |
| GSK1247446A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | CD40L, Day 180 [N=44;40;42;41;41] | 2.86 cells | Standard Deviation 8.48 |
| GSK1247446A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IFN-γ, Day 0 [N=44;46;43;45;39] | 14.42 cells | Standard Deviation 32.92 |
| GSK1247446A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IFN-γ, Day 180 [N=44;40;42;41;41] | 20.62 cells | Standard Deviation 47.56 |
| GSK1247446A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IL2, Day 0 [N=44;46;43;45;39] | 8.81 cells | Standard Deviation 16.65 |
| GSK1247446A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IL2, Day 21 [N=44;46;43;45;39] | 31.28 cells | Standard Deviation 59.89 |
| GSK1247446A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IL2, Day 180 [N=44;40;42;41;41] | 24.50 cells | Standard Deviation 82.62 |
| GSK1247446A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | TNF-α, Day 0 [N=44;46;43;45;39] | 15.42 cells | Standard Deviation 28.6 |
| GSK1247446A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | TNF-α, Day 21 [N=44;43;40;42;38] | 31.55 cells | Standard Deviation 59.52 |
| GSK1247446A 3 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | TNF-α, Day 180 [N=44;40;42;41;41] | 33.60 cells | Standard Deviation 80.5 |
| GSK1247446A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IL2, Day 21 [N=44;46;43;45;39] | 87.86 cells | Standard Deviation 244.84 |
| GSK1247446A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | All Doubles, Day 180 [N=44;40;42;41;41] | 97.27 cells | Standard Deviation 258.53 |
| GSK1247446A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IL2, Day 0 [N=44;46;43;45;39] | 46.22 cells | Standard Deviation 130.46 |
| GSK1247446A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | TNF-α, Day 0 [N=44;46;43;45;39] | 54.73 cells | Standard Deviation 156.41 |
| GSK1247446A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | CD40L, Day 21 [N=44;43;40;42;38] | 50.83 cells | Standard Deviation 193 |
| GSK1247446A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | CD40L, Day 0 [N=44;46;43;45;39] | 16.27 cells | Standard Deviation 56.56 |
| GSK1247446A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | All Doubles, Day 21 [N=44;43;40;42;38] | 109.86 cells | Standard Deviation 282.04 |
| GSK1247446A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | TNF-α, Day 180 [N=44;40;42;41;41] | 79.54 cells | Standard Deviation 208.13 |
| GSK1247446A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IFN-γ, Day 21 [N=44;43;40;42;38] | 64.98 cells | Standard Deviation 178.63 |
| GSK1247446A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | All Doubles, Day 0 [N=44;46;43;45;39] | 64.47 cells | Standard Deviation 181.32 |
| GSK1247446A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IL2, Day 180 [N=44;40;42;41;41] | 57.15 cells | Standard Deviation 136.73 |
| GSK1247446A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IFN-γ, Day 0 [N=44;46;43;45;39] | 44.80 cells | Standard Deviation 137.59 |
| GSK1247446A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | TNF-α, Day 21 [N=44;43;40;42;38] | 90.48 cells | Standard Deviation 239.47 |
| GSK1247446A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IFN-γ, Day 180 [N=44;40;42;41;41] | 79.85 cells | Standard Deviation 239.36 |
| GSK1247446A 4 Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | CD40L, Day 180 [N=44;40;42;41;41] | 1.68 cells | Standard Deviation 4.37 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IFN-γ, Day 180 [N=44;40;42;41;41] | 19.80 cells | Standard Deviation 37.25 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | TNF-α, Day 21 [N=44;43;40;42;38] | 37.82 cells | Standard Deviation 110.79 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IL2, Day 0 [N=44;46;43;45;39] | 43.59 cells | Standard Deviation 81.53 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | CD40L, Day 21 [N=44;43;40;42;38] | 37.55 cells | Standard Deviation 117.41 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | All Doubles, Day 0 [N=44;46;43;45;39] | 48.38 cells | Standard Deviation 82.57 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IL2, Day 21 [N=44;46;43;45;39] | 50.84 cells | Standard Deviation 116.74 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | CD40L, Day 0 [N=44;46;43;45;39] | 7.05 cells | Standard Deviation 20.43 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IL2, Day 180 [N=44;40;42;41;41] | 28.73 cells | Standard Deviation 55.08 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | All Doubles, Day 180 [N=44;40;42;41;41] | 30.98 cells | Standard Deviation 62.35 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | TNF-α, Day 180 [N=44;40;42;41;41] | 25.63 cells | Standard Deviation 56.06 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | TNF-α, Day 0 [N=44;46;43;45;39] | 46.18 cells | Standard Deviation 91.78 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | All Doubles, Day 21 [N=44;43;40;42;38] | 55.11 cells | Standard Deviation 126.17 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IFN-γ, Day 21 [N=44;43;40;42;38] | 32.11 cells | Standard Deviation 104.54 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IFN-γ, Day 0 [N=44;46;43;45;39] | 17.31 cells | Standard Deviation 38.5 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | CD40L, Day 180 [N=44;40;42;41;41] | 2.27 cells | Standard Deviation 5.83 |
Secondary
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
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 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).
Time frame: At Days 21 and 180
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable 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 (NUMBER) |
|---|---|---|---|
| GSK1247446A 1 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | SOLO, Day 21 [N=187;189;190;192;185] | 154 subjects |
| GSK1247446A 1 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | SOLO, Day 180 [N=189;190;192;192;187] | 117 subjects |
| GSK1247446A 1 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | WISC, Day 21 [N=187;189;190;192;185] | 150 subjects |
| GSK1247446A 1 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | WISC, Day 180 [N=189;190;192;192;187] | 112 subjects |
| GSK1247446A 1 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | MALA, Day 21 [N=187;189;190;192;185] | 136 subjects |
| GSK1247446A 1 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | MALA, Day 180 [N=189;190;192;192;187] | 99 subjects |
| GSK1247446A 2 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | MALA, Day 21 [N=187;189;190;192;185] | 127 subjects |
| GSK1247446A 2 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | MALA, Day 180 [N=189;190;192;192;187] | 99 subjects |
| GSK1247446A 2 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | SOLO, Day 21 [N=187;189;190;192;185] | 141 subjects |
| GSK1247446A 2 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | WISC, Day 21 [N=187;189;190;192;185] | 147 subjects |
| GSK1247446A 2 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | WISC, Day 180 [N=189;190;192;192;187] | 97 subjects |
| GSK1247446A 2 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | SOLO, Day 180 [N=189;190;192;192;187] | 108 subjects |
| GSK1247446A 3 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | WISC, Day 180 [N=189;190;192;192;187] | 112 subjects |
| GSK1247446A 3 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | MALA, Day 21 [N=187;189;190;192;185] | 128 subjects |
| GSK1247446A 3 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | SOLO, Day 21 [N=187;189;190;192;185] | 133 subjects |
| GSK1247446A 3 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | WISC, Day 21 [N=187;189;190;192;185] | 142 subjects |
| GSK1247446A 3 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | SOLO, Day 180 [N=189;190;192;192;187] | 102 subjects |
| GSK1247446A 3 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | MALA, Day 180 [N=189;190;192;192;187] | 98 subjects |
| GSK1247446A 4 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | WISC, Day 180 [N=189;190;192;192;187] | 106 subjects |
| GSK1247446A 4 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | SOLO, Day 180 [N=189;190;192;192;187] | 102 subjects |
| GSK1247446A 4 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | WISC, Day 21 [N=187;189;190;192;185] | 142 subjects |
| GSK1247446A 4 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | MALA, Day 180 [N=189;190;192;192;187] | 102 subjects |
| GSK1247446A 4 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | MALA, Day 21 [N=187;189;190;192;185] | 127 subjects |
| GSK1247446A 4 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | SOLO, Day 21 [N=187;189;190;192;185] | 119 subjects |
| Fluarix Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | MALA, Day 21 [N=187;189;190;192;185] | 125 subjects |
| Fluarix Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | WISC, Day 21 [N=187;189;190;192;185] | 118 subjects |
| Fluarix Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | SOLO, Day 180 [N=189;190;192;192;187] | 110 subjects |
| Fluarix Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | MALA, Day 180 [N=189;190;192;192;187] | 88 subjects |
| Fluarix Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | WISC, Day 180 [N=189;190;192;192;187] | 100 subjects |
| Fluarix Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | SOLO, Day 21 [N=187;189;190;192;185] | 131 subjects |
Secondary
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).
Time frame: At Days 0, 21 and 180
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable 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 (NUMBER) |
|---|---|---|---|
| GSK1247446A 1 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | WISC, Day 21 [N=187;189;190;192;185] | 183 subjects |
| GSK1247446A 1 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | SOLO, Day 21 [N=187;189;190;192;185] | 177 subjects |
| GSK1247446A 1 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | SOLO, Day 180 [N=189;190;192;192;187] | 157 subjects |
| GSK1247446A 1 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | MALA, Day 180 [N=189;190;192;192;187] | 174 subjects |
| GSK1247446A 1 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | WISC, Day 0 [N=187;189;190;192;185] | 90 subjects |
| GSK1247446A 1 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | MALA, Day 21 [N=187;189;190;192;185] | 183 subjects |
| GSK1247446A 1 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | WISC, Day 180 [N=189;190;192;192;187] | 175 subjects |
| GSK1247446A 1 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | SOLO, Day 0 [N=187;189;190;192;185] | 45 subjects |
| GSK1247446A 1 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | MALA, Day 0 [N=187;189;190;192;185] | 80 subjects |
| GSK1247446A 2 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | SOLO, Day 21 [N=187;189;190;192;185] | 170 subjects |
| GSK1247446A 2 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | MALA, Day 180 [N=189;190;192;192;187] | 177 subjects |
| GSK1247446A 2 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | MALA, Day 21 [N=187;189;190;192;185] | 186 subjects |
| GSK1247446A 2 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | SOLO, Day 0 [N=187;189;190;192;185] | 46 subjects |
| GSK1247446A 2 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | SOLO, Day 180 [N=189;190;192;192;187] | 144 subjects |
| GSK1247446A 2 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | WISC, Day 0 [N=187;189;190;192;185] | 90 subjects |
| GSK1247446A 2 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | WISC, Day 21 [N=187;189;190;192;185] | 186 subjects |
| GSK1247446A 2 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | WISC, Day 180 [N=189;190;192;192;187] | 175 subjects |
| GSK1247446A 2 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | MALA, Day 0 [N=187;189;190;192;185] | 88 subjects |
| GSK1247446A 3 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | WISC, Day 0 [N=187;189;190;192;185] | 96 subjects |
| GSK1247446A 3 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | MALA, Day 0 [N=187;189;190;192;185] | 81 subjects |
| GSK1247446A 3 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | WISC, Day 21 [N=187;189;190;192;185] | 185 subjects |
| GSK1247446A 3 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | MALA, Day 180 [N=189;190;192;192;187] | 167 subjects |
| GSK1247446A 3 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | WISC, Day 180 [N=189;190;192;192;187] | 175 subjects |
| GSK1247446A 3 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | SOLO, Day 21 [N=187;189;190;192;185] | 169 subjects |
| GSK1247446A 3 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | SOLO, Day 0 [N=187;189;190;192;185] | 43 subjects |
| GSK1247446A 3 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | SOLO, Day 180 [N=189;190;192;192;187] | 144 subjects |
| GSK1247446A 3 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | MALA, Day 21 [N=187;189;190;192;185] | 180 subjects |
| GSK1247446A 4 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | MALA, Day 0 [N=187;189;190;192;185] | 86 subjects |
| GSK1247446A 4 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | WISC, Day 0 [N=187;189;190;192;185] | 91 subjects |
| GSK1247446A 4 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | SOLO, Day 0 [N=187;189;190;192;185] | 52 subjects |
| GSK1247446A 4 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | SOLO, Day 21 [N=187;189;190;192;185] | 166 subjects |
| GSK1247446A 4 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | MALA, Day 21 [N=187;189;190;192;185] | 180 subjects |
| GSK1247446A 4 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | WISC, Day 180 [N=189;190;192;192;187] | 173 subjects |
| GSK1247446A 4 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | WISC, Day 21 [N=187;189;190;192;185] | 184 subjects |
| GSK1247446A 4 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | MALA, Day 180 [N=189;190;192;192;187] | 171 subjects |
| GSK1247446A 4 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | SOLO, Day 180 [N=189;190;192;192;187] | 151 subjects |
| Fluarix Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | MALA, Day 180 [N=189;190;192;192;187] | 169 subjects |
| Fluarix Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | SOLO, Day 0 [N=187;189;190;192;185] | 50 subjects |
| Fluarix Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | SOLO, Day 21 [N=187;189;190;192;185] | 172 subjects |
| Fluarix Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | SOLO, Day 180 [N=189;190;192;192;187] | 159 subjects |
| Fluarix Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | WISC, Day 0 [N=187;189;190;192;185] | 95 subjects |
| Fluarix Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | WISC, Day 21 [N=187;189;190;192;185] | 183 subjects |
| Fluarix Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | WISC, Day 180 [N=189;190;192;192;187] | 183 subjects |
| Fluarix Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | MALA, Day 0 [N=187;189;190;192;185] | 88 subjects |
| Fluarix Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | MALA, Day 21 [N=187;189;190;192;185] | 178 subjects |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site.
Time frame: During the 7-day (Days 0-6) post vaccination period
Population: The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1247446A 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Redness | 75 subjects |
| GSK1247446A 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness | 17 subjects |
| GSK1247446A 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 69 subjects |
| GSK1247446A 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling | 11 subjects |
| GSK1247446A 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Ecchymosis | 11 subjects |
| GSK1247446A 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Ecchymosis | 1 subjects |
| GSK1247446A 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Pain | 182 subjects |
| GSK1247446A 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 5 subjects |
| GSK1247446A 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 54 subjects |
| GSK1247446A 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Ecchymosis | 0 subjects |
| GSK1247446A 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Redness | 66 subjects |
| GSK1247446A 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling | 4 subjects |
| GSK1247446A 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness | 4 subjects |
| GSK1247446A 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 5 subjects |
| GSK1247446A 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Ecchymosis | 9 subjects |
| GSK1247446A 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Pain | 175 subjects |
| GSK1247446A 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Pain | 167 subjects |
| GSK1247446A 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 3 subjects |
| GSK1247446A 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling | 5 subjects |
| GSK1247446A 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Ecchymosis | 0 subjects |
| GSK1247446A 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 49 subjects |
| GSK1247446A 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness | 3 subjects |
| GSK1247446A 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Redness | 53 subjects |
| GSK1247446A 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Ecchymosis | 8 subjects |
| GSK1247446A 4 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness | 2 subjects |
| GSK1247446A 4 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 48 subjects |
| GSK1247446A 4 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling | 3 subjects |
| GSK1247446A 4 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Ecchymosis | 14 subjects |
| GSK1247446A 4 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Ecchymosis | 1 subjects |
| GSK1247446A 4 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 1 subjects |
| GSK1247446A 4 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Redness | 64 subjects |
| GSK1247446A 4 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Pain | 151 subjects |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling | 2 subjects |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 1 subjects |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 27 subjects |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Pain | 121 subjects |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Redness | 49 subjects |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Ecchymosis | 1 subjects |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness | 2 subjects |
| Fluarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Ecchymosis | 7 subjects |
Secondary
Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs).
MSCs were defined as conditions prompting emergency room visits or physician visits that were not related to common diseases or routine visits. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 = event which prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination
Time frame: From Day 0 to Day 180
Population: The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1247446A 1 Group | Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs). | Subjects with any MSCs | 70 subjects |
| GSK1247446A 1 Group | Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs). | Subjects with related MSCs | 5 subjects |
| GSK1247446A 1 Group | Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs). | Subjects with grade 3 and related MSCs | 2 subjects |
| GSK1247446A 2 Group | Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs). | Subjects with grade 3 and related MSCs | 2 subjects |
| GSK1247446A 2 Group | Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs). | Subjects with any MSCs | 56 subjects |
| GSK1247446A 2 Group | Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs). | Subjects with related MSCs | 2 subjects |
| GSK1247446A 3 Group | Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs). | Subjects with grade 3 and related MSCs | 0 subjects |
| GSK1247446A 3 Group | Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs). | Subjects with any MSCs | 53 subjects |
| GSK1247446A 3 Group | Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs). | Subjects with related MSCs | 0 subjects |
| GSK1247446A 4 Group | Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs). | Subjects with any MSCs | 64 subjects |
| GSK1247446A 4 Group | Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs). | Subjects with related MSCs | 0 subjects |
| GSK1247446A 4 Group | Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs). | Subjects with grade 3 and related MSCs | 0 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs). | Subjects with grade 3 and related MSCs | 1 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs). | Subjects with any MSCs | 45 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs). | Subjects with related MSCs | 1 subjects |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Assessed solicited general symptoms were arthralgia, fatigue, fever \[oral temperature above (\>) 38.0 degrees Celsius (°C)\], headache, myalgia, nausea and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.
Time frame: During the 7-day (Days 0-6) post vaccination period
Population: The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1247446A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue | 5 subjects |
| GSK1247446A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Arthralgia | 52 subjects |
| GSK1247446A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering | 64 subjects |
| GSK1247446A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia | 102 subjects |
| GSK1247446A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Nausea | 1 subjects |
| GSK1247446A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue | 81 subjects |
| GSK1247446A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Arthralgia | 64 subjects |
| GSK1247446A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache | 72 subjects |
| GSK1247446A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Nausea | 25 subjects |
| GSK1247446A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever >38°C | 27 subjects |
| GSK1247446A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering | 74 subjects |
| GSK1247446A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Arthralgia | 4 subjects |
| GSK1247446A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue | 103 subjects |
| GSK1247446A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia | 81 subjects |
| GSK1247446A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever ≥ 39°C | 2 subjects |
| GSK1247446A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache | 7 subjects |
| GSK1247446A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache | 90 subjects |
| GSK1247446A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering | 4 subjects |
| GSK1247446A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia | 6 subjects |
| GSK1247446A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fever | 23 subjects |
| GSK1247446A 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Nausea | 19 subjects |
| GSK1247446A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fever | 13 subjects |
| GSK1247446A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia | 85 subjects |
| GSK1247446A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache | 77 subjects |
| GSK1247446A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering | 5 subjects |
| GSK1247446A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache | 61 subjects |
| GSK1247446A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache | 2 subjects |
| GSK1247446A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Arthralgia | 49 subjects |
| GSK1247446A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering | 53 subjects |
| GSK1247446A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue | 90 subjects |
| GSK1247446A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering | 50 subjects |
| GSK1247446A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Nausea | 22 subjects |
| GSK1247446A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue | 4 subjects |
| GSK1247446A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Nausea | 2 subjects |
| GSK1247446A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue | 83 subjects |
| GSK1247446A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Nausea | 28 subjects |
| GSK1247446A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever >38°C | 16 subjects |
| GSK1247446A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia | 77 subjects |
| GSK1247446A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever ≥ 39°C | 0 subjects |
| GSK1247446A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Arthralgia | 4 subjects |
| GSK1247446A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia | 6 subjects |
| GSK1247446A 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Arthralgia | 51 subjects |
| GSK1247446A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Arthralgia | 32 subjects |
| GSK1247446A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Arthralgia | 38 subjects |
| GSK1247446A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Arthralgia | 2 subjects |
| GSK1247446A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue | 72 subjects |
| GSK1247446A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue | 86 subjects |
| GSK1247446A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue | 2 subjects |
| GSK1247446A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever >38°C | 8 subjects |
| GSK1247446A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever ≥ 39°C | 0 subjects |
| GSK1247446A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fever | 8 subjects |
| GSK1247446A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache | 68 subjects |
| GSK1247446A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache | 4 subjects |
| GSK1247446A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache | 49 subjects |
| GSK1247446A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia | 74 subjects |
| GSK1247446A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia | 4 subjects |
| GSK1247446A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia | 59 subjects |
| GSK1247446A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Nausea | 12 subjects |
| GSK1247446A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Nausea | 3 subjects |
| GSK1247446A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Nausea | 10 subjects |
| GSK1247446A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering | 40 subjects |
| GSK1247446A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering | 1 subjects |
| GSK1247446A 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering | 31 subjects |
| GSK1247446A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia | 0 subjects |
| GSK1247446A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever ≥ 39°C | 0 subjects |
| GSK1247446A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue | 78 subjects |
| GSK1247446A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Arthralgia | 39 subjects |
| GSK1247446A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Nausea | 11 subjects |
| GSK1247446A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue | 62 subjects |
| GSK1247446A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering | 29 subjects |
| GSK1247446A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Arthralgia | 31 subjects |
| GSK1247446A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Nausea | 13 subjects |
| GSK1247446A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering | 34 subjects |
| GSK1247446A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever >38°C | 6 subjects |
| GSK1247446A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache | 3 subjects |
| GSK1247446A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering | 1 subjects |
| GSK1247446A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue | 2 subjects |
| GSK1247446A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache | 66 subjects |
| GSK1247446A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia | 70 subjects |
| GSK1247446A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache | 49 subjects |
| GSK1247446A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia | 57 subjects |
| GSK1247446A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Nausea | 0 subjects |
| GSK1247446A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fever | 6 subjects |
| GSK1247446A 4 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Arthralgia | 0 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Arthralgia | 1 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia | 49 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever ≥ 39°C | 0 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia | 2 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever >38°C | 3 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia | 40 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue | 34 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering | 2 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Nausea | 11 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue | 2 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Arthralgia | 25 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Nausea | 0 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue | 47 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Nausea | 6 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Arthralgia | 20 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering | 8 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering | 12 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache | 1 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache | 51 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache | 36 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fever | 3 subjects |
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 activity Related = unsolicited AE assessed by the investigator as related to the vaccination.
Time frame: During the 21-day (Days 0-20) post vaccination period
Population: The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1247446A 1 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with any AE(s) | 85 subjects |
| GSK1247446A 1 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with related AE(s) | 37 subjects |
| GSK1247446A 1 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with grade 3 AE(s) | 4 subjects |
| GSK1247446A 2 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with grade 3 AE(s) | 10 subjects |
| GSK1247446A 2 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with any AE(s) | 91 subjects |
| GSK1247446A 2 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with related AE(s) | 41 subjects |
| GSK1247446A 3 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with grade 3 AE(s) | 3 subjects |
| GSK1247446A 3 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with any AE(s) | 70 subjects |
| GSK1247446A 3 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with related AE(s) | 25 subjects |
| GSK1247446A 4 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with any AE(s) | 82 subjects |
| GSK1247446A 4 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with related AE(s) | 19 subjects |
| GSK1247446A 4 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with grade 3 AE(s) | 10 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with grade 3 AE(s) | 5 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with any AE(s) | 80 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with related AE(s) | 14 subjects |
Secondary
Number of Subjects With 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 Day 0 to Day 180
Population: The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK1247446A 1 Group | Number of Subjects With Serious Adverse Events (SAEs). | 7 subjects |
| GSK1247446A 2 Group | Number of Subjects With Serious Adverse Events (SAEs). | 3 subjects |
| GSK1247446A 3 Group | Number of Subjects With Serious Adverse Events (SAEs). | 3 subjects |
| GSK1247446A 4 Group | Number of Subjects With Serious Adverse Events (SAEs). | 4 subjects |
| Fluarix Group | Number of Subjects With Serious Adverse Events (SAEs). | 2 subjects |
Secondary
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 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. The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).
Time frame: At Days 21 and 180
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable 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) |
|---|---|---|---|
| GSK1247446A 1 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | SOLO, Day 21 [N=187;189;190;192;185] | 15.6 fold increase |
| GSK1247446A 1 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | SOLO, Day 180 [N=189;190;192;192;187] | 6.4 fold increase |
| GSK1247446A 1 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | WISC, Day 21 [N=187;189;190;192;185] | 12.9 fold increase |
| GSK1247446A 1 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | WISC, Day 180 [N=189;190;192;192;187] | 6.0 fold increase |
| GSK1247446A 1 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | MALA, Day 21 [N=187;189;190;192;185] | 8.7 fold increase |
| GSK1247446A 1 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | MALA, Day 180 [N=189;190;192;192;187] | 4.2 fold increase |
| GSK1247446A 2 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | MALA, Day 21 [N=187;189;190;192;185] | 9.0 fold increase |
| GSK1247446A 2 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | MALA, Day 180 [N=189;190;192;192;187] | 4.4 fold increase |
| GSK1247446A 2 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | SOLO, Day 21 [N=187;189;190;192;185] | 12.7 fold increase |
| GSK1247446A 2 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | WISC, Day 21 [N=187;189;190;192;185] | 10.9 fold increase |
| GSK1247446A 2 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | WISC, Day 180 [N=189;190;192;192;187] | 5.0 fold increase |
| GSK1247446A 2 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | SOLO, Day 180 [N=189;190;192;192;187] | 5.9 fold increase |
| GSK1247446A 3 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | WISC, Day 180 [N=189;190;192;192;187] | 5.4 fold increase |
| GSK1247446A 3 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | MALA, Day 21 [N=187;189;190;192;185] | 8.7 fold increase |
| GSK1247446A 3 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | SOLO, Day 21 [N=187;189;190;192;185] | 12.8 fold increase |
| GSK1247446A 3 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | WISC, Day 21 [N=187;189;190;192;185] | 10.7 fold increase |
| GSK1247446A 3 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | SOLO, Day 180 [N=189;190;192;192;187] | 5.9 fold increase |
| GSK1247446A 3 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | MALA, Day 180 [N=189;190;192;192;187] | 4.4 fold increase |
| GSK1247446A 4 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | WISC, Day 180 [N=189;190;192;192;187] | 4.9 fold increase |
| GSK1247446A 4 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | SOLO, Day 180 [N=189;190;192;192;187] | 5.4 fold increase |
| GSK1247446A 4 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | WISC, Day 21 [N=187;189;190;192;185] | 10.1 fold increase |
| GSK1247446A 4 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | MALA, Day 180 [N=189;190;192;192;187] | 4.1 fold increase |
| GSK1247446A 4 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | MALA, Day 21 [N=187;189;190;192;185] | 7.4 fold increase |
| GSK1247446A 4 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | SOLO, Day 21 [N=187;189;190;192;185] | 10.1 fold increase |
| Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | MALA, Day 21 [N=187;189;190;192;185] | 8.1 fold increase |
| Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | WISC, Day 21 [N=187;189;190;192;185] | 9.0 fold increase |
| Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | SOLO, Day 180 [N=189;190;192;192;187] | 6.5 fold increase |
| Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | MALA, Day 180 [N=189;190;192;192;187] | 4.0 fold increase |
| Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | WISC, Day 180 [N=189;190;192;192;187] | 4.7 fold increase |
| Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | SOLO, Day 21 [N=187;189;190;192;185] | 12.7 fold increase |
Secondary
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
Titers are presented as geometric mean titers (GMTs). The 4 influenza strains assessed were A/Wisconsin (WISC), B/Malaysia (MALA), A/Brisbane (BRIS) and B/Florida (FLOR). The seropositivity cut-off assay was 1:28.
Time frame: At Days 0 and 21
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable 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) |
|---|---|---|---|
| GSK1247446A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | WISC, Day 0 [N=43;47;44;43;42] | 134.3 titers |
| GSK1247446A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | WISC, Day 21 [N=47;48;44;47;42] | 1193.7 titers |
| GSK1247446A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | MALA, Day 0 [N=46;48;44;44;42] | 34.1 titers |
| GSK1247446A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | MALA, Day 21 [N=44;48;43;42;42] | 162.5 titers |
| GSK1247446A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | BRIS, Day 0 [N=47;48;44;47;41] | 494.2 titers |
| GSK1247446A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | BRIS, Day 21 [N=47;48;44;47;42] | 1151.5 titers |
| GSK1247446A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLOR, Day 0 [N=45;48;44;47;42] | 48.9 titers |
| GSK1247446A 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLOR, Day 21 [N=43;48;43;43;42] | 94.3 titers |
| GSK1247446A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | MALA, Day 0 [N=46;48;44;44;42] | 36.5 titers |
| GSK1247446A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | BRIS, Day 21 [N=47;48;44;47;42] | 847.5 titers |
| GSK1247446A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | WISC, Day 0 [N=43;47;44;43;42] | 136.3 titers |
| GSK1247446A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | MALA, Day 21 [N=44;48;43;42;42] | 161.5 titers |
| GSK1247446A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | WISC, Day 21 [N=47;48;44;47;42] | 859.6 titers |
| GSK1247446A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLOR, Day 21 [N=43;48;43;43;42] | 113.6 titers |
| GSK1247446A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | BRIS, Day 0 [N=47;48;44;47;41] | 365.9 titers |
| GSK1247446A 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLOR, Day 0 [N=45;48;44;47;42] | 56.9 titers |
| GSK1247446A 3 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLOR, Day 0 [N=45;48;44;47;42] | 51.0 titers |
| GSK1247446A 3 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLOR, Day 21 [N=43;48;43;43;42] | 92.1 titers |
| GSK1247446A 3 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | MALA, Day 21 [N=44;48;43;42;42] | 141.0 titers |
| GSK1247446A 3 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | BRIS, Day 21 [N=47;48;44;47;42] | 884.2 titers |
| GSK1247446A 3 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | MALA, Day 0 [N=46;48;44;44;42] | 33.3 titers |
| GSK1247446A 3 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | WISC, Day 21 [N=47;48;44;47;42] | 1027.9 titers |
| GSK1247446A 3 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | WISC, Day 0 [N=43;47;44;43;42] | 160.8 titers |
| GSK1247446A 3 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | BRIS, Day 0 [N=47;48;44;47;41] | 392.5 titers |
| GSK1247446A 4 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | WISC, Day 21 [N=47;48;44;47;42] | 842.3 titers |
| GSK1247446A 4 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | MALA, Day 0 [N=46;48;44;44;42] | 27.7 titers |
| GSK1247446A 4 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | MALA, Day 21 [N=44;48;43;42;42] | 130.5 titers |
| GSK1247446A 4 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | BRIS, Day 0 [N=47;48;44;47;41] | 445.7 titers |
| GSK1247446A 4 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | BRIS, Day 21 [N=47;48;44;47;42] | 1038.2 titers |
| GSK1247446A 4 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLOR, Day 21 [N=43;48;43;43;42] | 82.7 titers |
| GSK1247446A 4 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | WISC, Day 0 [N=43;47;44;43;42] | 148.0 titers |
| GSK1247446A 4 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLOR, Day 0 [N=45;48;44;47;42] | 46.8 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | MALA, Day 21 [N=44;48;43;42;42] | 166.0 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLOR, Day 21 [N=43;48;43;43;42] | 131.1 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | MALA, Day 0 [N=46;48;44;44;42] | 49.7 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FLOR, Day 0 [N=45;48;44;47;42] | 76.7 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | WISC, Day 0 [N=43;47;44;43;42] | 212.5 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | BRIS, Day 21 [N=47;48;44;47;42] | 867.1 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | WISC, Day 21 [N=47;48;44;47;42] | 864.0 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | BRIS, Day 0 [N=47;48;44;47;41] | 466.8 titers |