Influenza
Conditions
Keywords
Influenza vaccine, Prophylaxis Influenza vaccine
Brief summary
The purpose of this study is to evaluate the immunogenicity and the safety of the candidate vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years and above
Interventions
BIOLOGICALGSK1247446A Group
Low dose influenza vaccine adjuvanted with AS03 compared
BIOLOGICALFluarix™
GlaxoSmithKline (GSK) Biologicals' inactivated influenza split vaccine.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that they can and wil comply with the requirements of the protocol should be enrolled in the study. * A male or female 60 years or older at the time of the first vaccination. * Free of obvious health problems
Exclusion criteria
* Use of non-registered products * Administration of immune-modifying drugs. * Administration of vaccine 30 days before enrolment in study. * Immunosuppressive or immunodeficient condition. * Hypersensitivity to a previous dose of influenza vaccine * Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality. * History of confirmed influenza infection within the last 12 Months. * Acute disease at the time of enrolment/vaccination. * History of allergy or reactions likely to be exacerbated by any component of the vaccine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | At Days 0 and 21 | Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia. The seropositivity cut-off assay was 1:10. |
| Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | At Day 21 | 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/New Caledonia, A/Wisconsin and B/Malaysia. |
| Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | At Day 0 and Day 21 | A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia. |
| Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | At Day 21 | 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/New Caledonia, A/Wisconsin and B/Malaysia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | During the 30-day (Days 0-29) 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 everyday activities. Related = unsolicited AE assessed by the investigator as related to the vaccination. |
| Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | At Days 0 and 21 | The geometric 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-g), at least IL2 and at least TNF alpha (TNF-α). |
| Number of Subjects With Any and Related Serious Adverse Events (SAEs). | During the entire study period (from Day 0 to Day 29) | 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. Related = SAE considered by the investigator to have a causal relationship to study vaccination. |
| Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | At Days 0 and 21 | The geometric 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-g), at least IL2 and at least TNF alpha (TNF-α). |
| Number of Subjects With Any, Grade 3 and Related 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 activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms were considered to be related to vaccination. |
| 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 \[axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache, muscle aches 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. |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GSK1247446A Group Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. | 75 |
| Fluarix Group Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. | 75 |
| Total | 150 |
Baseline characteristics
| Characteristic | GSK1247446A Group | Fluarix Group | Total |
|---|---|---|---|
| Age, Continuous | 64.4 Years STANDARD_DEVIATION 4.22 | 64.5 Years STANDARD_DEVIATION 4.18 | 64.4 Years STANDARD_DEVIATION 4.2 |
| Sex: Female, Male Female | 38 Participants | 38 Participants | 76 Participants |
| Sex: Female, Male Male | 37 Participants | 37 Participants | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 69 / 75 | 45 / 75 |
| serious Total, serious adverse events | 0 / 75 | 1 / 75 |
Outcome results
Primary
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/New Caledonia, A/Wisconsin and B/Malaysia.
Time frame: At Day 21
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1247446A Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | A/New Caledonia | 21 subjects |
| GSK1247446A Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | A/Wisconsin | 52 subjects |
| GSK1247446A Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | B/Malaysia | 46 subjects |
| Fluarix Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | A/New Caledonia | 12 subjects |
| Fluarix Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | A/Wisconsin | 40 subjects |
| Fluarix Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | B/Malaysia | 31 subjects |
Primary
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/New Caledonia, A/Wisconsin and B/Malaysia.
Time frame: At Day 0 and Day 21
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1247446A Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/New Caledonia, Day 0 | 40 subjects |
| GSK1247446A Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/New Caledonia, Day 21 | 68 subjects |
| GSK1247446A Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/Wisconsin, Day 0 | 35 subjects |
| GSK1247446A Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/Wisconsin, Day 21 | 69 subjects |
| GSK1247446A Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | B/Malaysia, Day 0 | 28 subjects |
| GSK1247446A Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | B/Malaysia, Day 21 | 72 subjects |
| Fluarix Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | B/Malaysia, Day 0 | 39 subjects |
| Fluarix Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/New Caledonia, Day 0 | 54 subjects |
| Fluarix Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/Wisconsin, Day 21 | 71 subjects |
| Fluarix Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/New Caledonia, Day 21 | 73 subjects |
| Fluarix Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | B/Malaysia, Day 21 | 70 subjects |
| Fluarix Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A/Wisconsin, Day 0 | 44 subjects |
Primary
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/New Caledonia, A/Wisconsin and B/Malaysia.
Time frame: At Day 21
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1247446A Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New Caledonia | 2.6 fold increase |
| GSK1247446A Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/Wisconsin | 8.7 fold increase |
| GSK1247446A Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | B/Malaysia | 6.0 fold increase |
| Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New Caledonia | 2.1 fold increase |
| Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/Wisconsin | 5.5 fold increase |
| Fluarix Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | B/Malaysia | 4.2 fold increase |
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/New Caledonia, A/Wisconsin and B/Malaysia. The seropositivity cut-off assay was 1:10.
Time frame: At Days 0 and 21
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1247446A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New Caledonia, Day 0 | 45.3 titers |
| GSK1247446A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New Caledonia, Day 21 | 116.4 titers |
| GSK1247446A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/Wisconsin, Day 0 | 28.8 titers |
| GSK1247446A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/Wisconsin, Day 21 | 251.9 titers |
| GSK1247446A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | B/Malaysia, Day 0 | 27.1 titers |
| GSK1247446A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | B/Malaysia, Day 21 | 161.6 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | B/Malaysia, Day 0 | 31.6 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New Caledonia, Day 0 | 81.1 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/Wisconsin, Day 21 | 228.4 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/New Caledonia, Day 21 | 170.9 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | B/Malaysia, Day 21 | 131.4 titers |
| Fluarix Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. | A/Wisconsin, Day 0 | 41.3 titers |
Secondary
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
The geometric 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-g), at least IL2 and at least TNF alpha (TNF-α).
Time frame: At Days 0 and 21
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IFN-g, B/Malaysia, Day 21 [N=73;73] | 1081.98 cytokine-positive cells/million cells | Standard Deviation 840.54 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | CD40L, B/Malaysia, Day 0 [N=73;71] | 424.07 cytokine-positive cells/million cells | Standard Deviation 328.4 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IFN-g, A/New Caledonia, Day 0 [N=73;71] | 225.76 cytokine-positive cells/million cells | Standard Deviation 265.96 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | TNF-α, A/Wisconsin, Day 21 [N=73;73] | 84.99 cytokine-positive cells/million cells | Standard Deviation 308.52 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IFN-g, A/New Caledonia, Day 21 [N=73;73] | 527.98 cytokine-positive cells/million cells | Standard Deviation 522.3 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | CD40L, B/Malaysia, Day 21 [N=73;73] | 1409.79 cytokine-positive cells/million cells | Standard Deviation 983.81 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IFN-g, A/Wisconsin, Day 0 [N=73;71] | 24.45 cytokine-positive cells/million cells | Standard Deviation 114.69 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | All Doubles, A/New Caledonia, Day 21 [N=73;73] | 872.71 cytokine-positive cells/million cells | Standard Deviation 662.32 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IFN-g, A/Wisconsin, Day 21 [N=73;73] | 83.99 cytokine-positive cells/million cells | Standard Deviation 365.27 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | CD40L, A/New Caledonia, Day 0 [N=73;71] | 317.25 cytokine-positive cells/million cells | Standard Deviation 337.18 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IL2, B/Malaysia, Day 0 [N=73;71] | 379.42 cytokine-positive cells/million cells | Standard Deviation 318.77 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | All Doubles, B/Malaysia, Day 21 [N=73;73] | 1555.92 cytokine-positive cells/million cells | Standard Deviation 1060.11 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IL2, B/Malaysia, Day 21 [N=73;73] | 1297.82 cytokine-positive cells/million cells | Standard Deviation 880.34 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | CD40L, A/New Caledonia, Day 21 [N=73;73] | 786.97 cytokine-positive cells/million cells | Standard Deviation 598.31 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IL2, A/New Caledonia, Day 0 [N=73;71] | 256.57 cytokine-positive cells/million cells | Standard Deviation 307.83 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | All Doubles, A/Wisconsin, Day 0 [N=73;71] | 37.33 cytokine-positive cells/million cells | Standard Deviation 155.75 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IL2, A/New Caledonia, Day 21 [N=73;73] | 652.75 cytokine-positive cells/million cells | Standard Deviation 539.89 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | CD40L, A/Wisconsin, Day 0 [N=73;71] | 36.53 cytokine-positive cells/million cells | Standard Deviation 145.9 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IL2, A/Wisconsin, Day 0 [N=73;71] | 31.74 cytokine-positive cells/million cells | Standard Deviation 130.05 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | All Doubles, B/Malaysia, Day 0 [N=73;71] | 436.58 cytokine-positive cells/million cells | Standard Deviation 348.81 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IL2, A/Wisconsin, Day 21 [N=73;73] | 89.97 cytokine-positive cells/million cells | Standard Deviation 301.28 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | CD40L, A/Wisconsin, Day 21 [N=73;73] | 97.23 cytokine-positive cells/million cells | Standard Deviation 346.59 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | TNF-α, B/Malaysia, Day 0 [N=73;71] | 332.83 cytokine-positive cells/million cells | Standard Deviation 298.11 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | All Doubles, A/Wisconsin, Day 21 [N=73;73] | 113.74 cytokine-positive cells/million cells | Standard Deviation 412.68 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | TNF-α, B/Malaysia, Day 21 [N=73;73] | 1098.28 cytokine-positive cells/million cells | Standard Deviation 869.02 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IFN-g, B/Malaysia, Day 0 [N=73;71] | 265.46 cytokine-positive cells/million cells | Standard Deviation 297.9 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | TNF-α, A/New Caledonia, Day 0 [N=73;71] | 219.03 cytokine-positive cells/million cells | Standard Deviation 276.48 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | All Doubles, A/New Caledonia, Day 0 [N=73;71] | 322.57 cytokine-positive cells/million cells | Standard Deviation 348.2 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | TNF-α, A/New Caledonia, Day 21 [N=73;73] | 582.62 cytokine-positive cells/million cells | Standard Deviation 506.95 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | TNF-α, A/Wisconsin, Day 0 [N=73;71] | 23.29 cytokine-positive cells/million cells | Standard Deviation 119.05 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | TNF-α, A/New Caledonia, Day 21 [N=73;73] | 317.96 cytokine-positive cells/million cells | Standard Deviation 416.78 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | TNF-α, A/Wisconsin, Day 0 [N=73;71] | 36.16 cytokine-positive cells/million cells | Standard Deviation 190.06 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | TNF-α, A/Wisconsin, Day 21 [N=73;73] | 44.97 cytokine-positive cells/million cells | Standard Deviation 157.29 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | All Doubles, B/Malaysia, Day 0 [N=73;71] | 451.35 cytokine-positive cells/million cells | Standard Deviation 448.35 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | All Doubles, B/Malaysia, Day 21 [N=73;73] | 736.15 cytokine-positive cells/million cells | Standard Deviation 588.56 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | All Doubles, A/New Caledonia, Day 0 [N=73;71] | 370.36 cytokine-positive cells/million cells | Standard Deviation 408.19 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | All Doubles, A/New Caledonia, Day 21 [N=73;73] | 510.86 cytokine-positive cells/million cells | Standard Deviation 604.98 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | All Doubles, A/Wisconsin, Day 0 [N=73;71] | 50.79 cytokine-positive cells/million cells | Standard Deviation 212.97 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | All Doubles, A/Wisconsin, Day 21 [N=73;73] | 72.43 cytokine-positive cells/million cells | Standard Deviation 190.6 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | CD40L, B/Malaysia, Day 0 [N=73;71] | 433.94 cytokine-positive cells/million cells | Standard Deviation 406.2 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | CD40L, B/Malaysia, Day 21 [N=73;73] | 694.68 cytokine-positive cells/million cells | Standard Deviation 550.36 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | CD40L, A/New Caledonia, Day 0 [N=73;71] | 354.60 cytokine-positive cells/million cells | Standard Deviation 399.44 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | CD40L, A/New Caledonia, Day 21 [N=73;73] | 475.96 cytokine-positive cells/million cells | Standard Deviation 576.45 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | CD40L, A/Wisconsin, Day 0 [N=73;71] | 52.22 cytokine-positive cells/million cells | Standard Deviation 208.27 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | CD40L, A/Wisconsin, Day 21 [N=73;73] | 65.37 cytokine-positive cells/million cells | Standard Deviation 168.16 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IFN-g, B/Malaysia, Day 0 [N=73;71] | 244.30 cytokine-positive cells/million cells | Standard Deviation 377.07 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IFN-g, B/Malaysia, Day 21 [N=73;73] | 530.64 cytokine-positive cells/million cells | Standard Deviation 451.71 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IFN-g, A/New Caledonia, Day 0 [N=73;71] | 239.78 cytokine-positive cells/million cells | Standard Deviation 285.26 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IFN-g, A/New Caledonia, Day 21 [N=73;73] | 407.10 cytokine-positive cells/million cells | Standard Deviation 492.37 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IFN-g, A/Wisconsin, Day 0 [N=73;71] | 30.49 cytokine-positive cells/million cells | Standard Deviation 83.91 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IFN-g, A/Wisconsin, Day 21 [N=73;73] | 38.46 cytokine-positive cells/million cells | Standard Deviation 126.65 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IL2, B/Malaysia, Day 0 [N=73;71] | 382.48 cytokine-positive cells/million cells | Standard Deviation 378.85 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IL2, B/Malaysia, Day 21 [N=73;73] | 647.93 cytokine-positive cells/million cells | Standard Deviation 508.83 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IL2, A/New Caledonia, Day 0 [N=73;71] | 220.62 cytokine-positive cells/million cells | Standard Deviation 301.07 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IL2, A/New Caledonia, Day 21 [N=73;73] | 300.71 cytokine-positive cells/million cells | Standard Deviation 502.3 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IL2, A/Wisconsin, Day 0 [N=73;71] | 53.93 cytokine-positive cells/million cells | Standard Deviation 127.47 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | IL2, A/Wisconsin, Day 21 [N=73;73] | 53.47 cytokine-positive cells/million cells | Standard Deviation 148.09 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | TNF-α, B/Malaysia, Day 0 [N=73;71] | 331.52 cytokine-positive cells/million cells | Standard Deviation 383.96 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | TNF-α, B/Malaysia, Day 21 [N=73;73] | 532.81 cytokine-positive cells/million cells | Standard Deviation 420.99 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells. | TNF-α, A/New Caledonia, Day 0 [N=73;71] | 261.91 cytokine-positive cells/million cells | Standard Deviation 369.6 |
Secondary
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
The geometric 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-g), at least IL2 and at least TNF alpha (TNF-α).
Time frame: At Days 0 and 21
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IFN-g, A/New Caledonia, Day 21 [N=73;70] | 5.04 cytokine-positive cells/million cells | Standard Deviation 174.85 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | CD40L, A/New Caledonia, Day 0 [N=71;69] | 2.56 cytokine-positive cells/million cells | Standard Deviation 113.11 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IFN-g, A/Wisconsin, Day 0 [N=72;69] | 2.84 cytokine-positive cells/million cells | Standard Deviation 73.55 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | All doubles, B/Malaysia, Day 21 [N=73;72] | 7.82 cytokine-positive cells/million cells | Standard Deviation 95.8 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IFN-g, A/Wisconsin, Day 21 [N=73;73] | 2.46 cytokine-positive cells/million cells | Standard Deviation 44.69 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | CD40L, A/New Caledonia, Day 21 [N=73;70] | 4.17 cytokine-positive cells/million cells | Standard Deviation 93.16 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IL2, B/Malaysia, Day 0 [N=72;69] | 3.60 cytokine-positive cells/million cells | Standard Deviation 92.44 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | All doubles, A/Wisconsin, Day 21 [N=73;73] | 3.35 cytokine-positive cells/million cells | Standard Deviation 56.7 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IL2, B/Malaysia, Day 21 [N=73;72] | 3.45 cytokine-positive cells/million cells | Standard Deviation 60.32 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | CD40L, A/Wisconsin, Day 0 [N=72;69] | 2.15 cytokine-positive cells/million cells | Standard Deviation 53.59 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IL2, A/New Caledonia, Day 0 [N=71;69] | 2.48 cytokine-positive cells/million cells | Standard Deviation 131.52 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | All doubles, A/New Caledonia, Day 21 [N=73;70] | 7.81 cytokine-positive cells/million cells | Standard Deviation 191.24 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IL2, A/New Caledonia, Day 21 [N=73;70] | 4.63 cytokine-positive cells/million cells | Standard Deviation 125.59 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | CD40L, A/Wisconsin, Day 21 [N=73;73] | 2.18 cytokine-positive cells/million cells | Standard Deviation 39.28 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IL2, A/Wisconsin, Day 0 [N=72;69] | 1.93 cytokine-positive cells/million cells | Standard Deviation 55.19 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | CD40L, B/Malaysia, Day 0 [N=72;69] | 2.20 cytokine-positive cells/million cells | Standard Deviation 34.98 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IL2, A/Wisconsin, Day 21 [N=73;73] | 2.76 cytokine-positive cells/million cells | Standard Deviation 45.28 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IFN-g, B/Malaysia, Day 0 [N=72;69] | 4.28 cytokine-positive cells/million cells | Standard Deviation 56.03 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | TNF-α, B/Malaysia, Day 0 [N=72;69] | 8.41 cytokine-positive cells/million cells | Standard Deviation 83.63 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | All doubles, A/New Caledonia, Day 0 [N=71;69] | 6.22 cytokine-positive cells/million cells | Standard Deviation 233.32 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | TNF-α, B/Malaysia, Day 21 [N=73;72] | 6.25 cytokine-positive cells/million cells | Standard Deviation 91.95 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IFN-g, B/Malaysia, Day 21 [N=73;72] | 6.24 cytokine-positive cells/million cells | Standard Deviation 74.51 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | TNF-α, A/New Caledonia, Day 0 [N=71;69] | 6.07 cytokine-positive cells/million cells | Standard Deviation 218.59 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | CD40L, B/Malaysia, Day 21 [N=73;72] | 3.66 cytokine-positive cells/million cells | Standard Deviation 45.91 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | TNF-α, A/New Caledonia, Day 21 [N=73;70] | 8.15 cytokine-positive cells/million cells | Standard Deviation 171.91 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IFN-g, A/New Caledonia, Day 0 [N=71;69] | 5.67 cytokine-positive cells/million cells | Standard Deviation 231.67 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | TNF-α, A/Wisconsin, Day 0 [N=72;69] | 3.12 cytokine-positive cells/million cells | Standard Deviation 58.61 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | All doubles, A/Wisconsin, Day 0 [N=72;69] | 3.93 cytokine-positive cells/million cells | Standard Deviation 82.82 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | TNF-α, A/Wisconsin, Day 21 [N=73;73] | 2.56 cytokine-positive cells/million cells | Standard Deviation 49.21 |
| GSK1247446A Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | All doubles, B/Malaysia, Day 0 [N=72;69] | 7.91 cytokine-positive cells/million cells | Standard Deviation 83.49 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | TNF-α, A/Wisconsin, Day 21 [N=73;73] | 2.33 cytokine-positive cells/million cells | Standard Deviation 70.96 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | All doubles, B/Malaysia, Day 0 [N=72;69] | 4.17 cytokine-positive cells/million cells | Standard Deviation 70.59 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | All doubles, B/Malaysia, Day 21 [N=73;72] | 3.74 cytokine-positive cells/million cells | Standard Deviation 120.67 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | All doubles, A/New Caledonia, Day 0 [N=71;69] | 7.31 cytokine-positive cells/million cells | Standard Deviation 112.56 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | All doubles, A/New Caledonia, Day 21 [N=73;70] | 4.40 cytokine-positive cells/million cells | Standard Deviation 141.07 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | All doubles, A/Wisconsin, Day 0 [N=72;69] | 6.79 cytokine-positive cells/million cells | Standard Deviation 85.9 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | All doubles, A/Wisconsin, Day 21 [N=73;73] | 2.79 cytokine-positive cells/million cells | Standard Deviation 70.15 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | CD40L, B/Malaysia, Day 0 [N=72;69] | 2.11 cytokine-positive cells/million cells | Standard Deviation 36.15 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | CD40L, B/Malaysia, Day 21 [N=73;72] | 1.98 cytokine-positive cells/million cells | Standard Deviation 32.45 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | CD40L, A/New Caledonia, Day 0 [N=71;69] | 5.34 cytokine-positive cells/million cells | Standard Deviation 65.09 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | CD40L, A/New Caledonia, Day 21 [N=73;70] | 2.11 cytokine-positive cells/million cells | Standard Deviation 51.19 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | CD40L, A/Wisconsin, Day 0 [N=72;69] | 2.70 cytokine-positive cells/million cells | Standard Deviation 44.68 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | CD40L, A/Wisconsin, Day 21 [N=73;73] | 2.11 cytokine-positive cells/million cells | Standard Deviation 39.64 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IFN-g, B/Malaysia, Day 0 [N=72;69] | 2.71 cytokine-positive cells/million cells | Standard Deviation 56.13 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IFN-g, B/Malaysia, Day 21 [N=73;72] | 3.53 cytokine-positive cells/million cells | Standard Deviation 118.94 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IFN-g, A/New Caledonia, Day 0 [N=71;69] | 4.34 cytokine-positive cells/million cells | Standard Deviation 97.73 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IFN-g, A/New Caledonia, Day 21 [N=73;70] | 3.98 cytokine-positive cells/million cells | Standard Deviation 133.45 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IFN-g, A/Wisconsin, Day 0 [N=72;69] | 4.40 cytokine-positive cells/million cells | Standard Deviation 69.48 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IFN-g, A/Wisconsin, Day 21 [N=73;73] | 1.98 cytokine-positive cells/million cells | Standard Deviation 36.44 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IL2, B/Malaysia, Day 0 [N=72;69] | 2.12 cytokine-positive cells/million cells | Standard Deviation 44.04 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IL2, B/Malaysia, Day 21 [N=73;72] | 2.44 cytokine-positive cells/million cells | Standard Deviation 32.77 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IL2, A/New Caledonia, Day 0 [N=71;69] | 4.43 cytokine-positive cells/million cells | Standard Deviation 60.02 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IL2, A/New Caledonia, Day 21 [N=73;70] | 2.44 cytokine-positive cells/million cells | Standard Deviation 62.17 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IL2, A/Wisconsin, Day 0 [N=72;69] | 3.23 cytokine-positive cells/million cells | Standard Deviation 61.15 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | IL2, A/Wisconsin, Day 21 [N=73;73] | 2.55 cytokine-positive cells/million cells | Standard Deviation 61.31 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | TNF-α, B/Malaysia, Day 0 [N=72;69] | 4.29 cytokine-positive cells/million cells | Standard Deviation 78.46 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | TNF-α, B/Malaysia, Day 21 [N=73;72] | 3.90 cytokine-positive cells/million cells | Standard Deviation 124.66 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | TNF-α, A/New Caledonia, Day 0 [N=71;69] | 6.05 cytokine-positive cells/million cells | Standard Deviation 114.14 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | TNF-α, A/New Caledonia, Day 21 [N=73;70] | 5.50 cytokine-positive cells/million cells | Standard Deviation 128.58 |
| Fluarix Group | Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells. | TNF-α, A/Wisconsin, Day 0 [N=72;69] | 5.55 cytokine-positive cells/million cells | Standard Deviation 92.14 |
Secondary
Number of Subjects With Any and Related Serious Adverse Events (SAEs).
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. Related = SAE considered by the investigator to have a causal relationship to study vaccination.
Time frame: During the entire study period (from Day 0 to Day 29)
Population: The analysis was performed on the Total Vaccinated cohort, on all subjects with the documented dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1247446A Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | Subjects with any SAE(s) | 0 subjects |
| GSK1247446A Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | Subjects with related SAE(s) | 0 subjects |
| Fluarix Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | Subjects with any SAE(s) | 1 subjects |
| Fluarix Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | Subjects with related SAE(s) | 0 subjects |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Assessed solicited general symptoms were arthralgia, fatigue, fever \[axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache, muscle aches 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 performed on the Total Vaccinated cohort, on all subjects with the documented dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Arthralgia | 12 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Arthralgia | 0 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Arthralgia | 10 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue | 30 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue | 0 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue | 29 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever ≥ 37.5°C | 2 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever > 39.0°C | 0 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fever | 2 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache | 28 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache | 0 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache | 24 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Muscle aches | 17 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Muscle aches | 1 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Muscle aches | 15 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering | 10 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering | 1 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering | 9 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Muscle aches | 0 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Arthralgia | 8 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache | 10 subjects |
| Fluarix 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. | Related Shivering | 3 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Arthralgia | 4 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache | 0 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue | 13 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Muscle aches | 8 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue | 0 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache | 7 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue | 12 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering | 0 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever ≥ 37.5°C | 0 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Muscle aches | 10 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever > 39.0°C | 0 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering | 3 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fever | 0 subjects |
Secondary
Number of Subjects With Any, Grade 3 and Related 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 activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms were considered to be related to vaccination.
Time frame: During the 7-day (Days 0-6) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, on all subjects with the documented dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Any Ecchymosis | 1 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Ecchymosis > 50 mm | 1 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Any Pain | 57 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Grade 3 Pain | 1 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Any Redness | 14 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Redness > 50 mm | 4 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Any Swelling | 18 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Swelling > 50 mm | 3 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Swelling > 50 mm | 1 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Any Ecchymosis | 1 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Any Redness | 8 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Ecchymosis > 50 mm | 0 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Any Swelling | 5 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Any Pain | 25 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Redness > 50 mm | 0 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. | Grade 3 Pain | 0 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 everyday activities. Related = unsolicited AE assessed by the investigator as related to the vaccination.
Time frame: During the 30-day (Days 0-29) post vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, on all subjects with the documented dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with any AE(s) | 31 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with grade 3 AE(s) | 1 subjects |
| GSK1247446A Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with related AE(s) | 11 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with any AE(s) | 22 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with grade 3 AE(s) | 0 subjects |
| Fluarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Subjects with related AE(s) | 7 subjects |