Influenza
Conditions
Brief summary
As influenza vaccine efficacy is reported to be lower in elderly subjects compared to healthy adults, probably as a result of immunosenescence, there is a desire to devise ways to increase the current vaccines efficacy for this target population. Adjuvants are known to boost immune responses, thus representing one way to increase the efficacy of the current GlaxoSmithKline Fluarix™ influenza vaccine in elderly subjects. The purpose of this study is to evaluate the immunogenicity and the reactogenicity of a vaccination with four different adjuvanted GlaxoSmithKline influenza vaccines administered to elderly subjects. For immunogenicity and safety evaluations, healthy adults aged 18 to 40 years old and elderly aged 65 years and older will receive Fluarix™ and form the control groups of this trial.
Interventions
BIOLOGICALFluarix
1 dose administered intramuscularly in the deltoid region of the non-dominant arm
BIOLOGICALFluarix-AS25
1 dose administered intramuscularly into the deltoid region of the non-dominant arm
BIOLOGICALFluarix-AS50
1 dose administered intramuscularly into the deltoid region of the non-dominant arm
BIOLOGICALFluarix-AS01B
1 dose administered intramuscularly into the deltoid region of the non-dominant arm
BIOLOGICALFluarix-AS01E
1 dose administered intramuscularly into the deltoid region of the non-dominant arm
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* A male or female aged between 18 and 40 years or aged 65 years or older at the time of the vaccination. * Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the 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 six months prior to the administration of the study vaccine. * History of confirmed influenza infection since a year from the date of previous vaccination. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination * History of hypersensitivity to vaccines. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * Acute disease at the time of enrolment. * Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T-cells Expressing at Least 2 Markers | At Day 21 | The frequency was expressed as the geometric mean of influenza-specific CD4 T-cells, expressing at least 2 markers among CD40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α) and Interferon-γ (IFN-γ ) upon in vitro stimulation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease | At Day 90 and Day 180 | Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B). Seropositivity was defined as a serum HI titer of ≥ 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 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B). |
| 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 change in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to pre-vaccination time point. The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B). |
| Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | At Day 0 and at Day 21 | A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B). |
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | At Day 0 and at Day 21 | Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B). Seropositivity was defined as a serum HI titer greater than or equal to (≥) 1:10. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | During the 7-day (Days 0-6) follow-up period after vaccination | Assessed solicited general symptoms were fatigue, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], headache, joint pain, muscle aches and shivering. Any = occurrence of any general symptom regardless of intensity grade and relationship to vaccination. Grade 3 = symptoms that prevented normal activity. Grade 3 fever = fever \>39°C. Related = general symptom 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) follow-up period after vaccination | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 =event that prevented normal everyday activity. Related = event assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs). | During the entire study period (Day 0 - Day 180) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | During the 7-day (Days 0-6) follow-up period after vaccination | Assessed solicited local symptoms were haematoma, pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain which prevented normal everyday activity. Grade 3 haematoma/redness/swelling = haematoma/redness/swelling spreading beyond 50 millimeters (mm). |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fluarix 18-40 Y Group Subjects (aged 18-40 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. | 75 |
| Fluarix ≥65 Y Group Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. | 50 |
| Fluarix-AS25 Group Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS25, administered intramuscularly in the deltoid region of the non-dominant arm. | 75 |
| Fluarix-AS50 Group Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS50, administered intramuscularly in the deltoid region of the non-dominant arm. | 75 |
| Fluarix- AS01B Group Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01B, administered intramuscularly in the deltoid region of the non-dominant arm. | 75 |
| Fluarix- AS01E Group Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01E, administered intramuscularly in the deltoid region of the non-dominant arm. | 75 |
| Total | 425 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | Fluarix 18-40 Y Group | Fluarix ≥65 Y Group | Fluarix-AS25 Group | Fluarix-AS50 Group | Fluarix- AS01B Group | Fluarix- AS01E Group | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 25.9 Years STANDARD_DEVIATION 5.47 | 69.3 Years STANDARD_DEVIATION 3.31 | 69.2 Years STANDARD_DEVIATION 2.98 | 69.1 Years STANDARD_DEVIATION 3.51 | 69.5 Years STANDARD_DEVIATION 3.3 | 69.5 Years STANDARD_DEVIATION 4.06 | 61.66 Years STANDARD_DEVIATION 17.02 |
| Race/Ethnicity, Customized Geographic ancestry Asian - Central/South Asian heritage | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry Other | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Geographic ancestry White - Caucasian/European heritage | 72 Participants | 50 Participants | 75 Participants | 75 Participants | 75 Participants | 75 Participants | 422 Participants |
| Sex: Female, Male Female | 46 Participants | 19 Participants | 29 Participants | 34 Participants | 36 Participants | 29 Participants | 193 Participants |
| Sex: Female, Male Male | 29 Participants | 31 Participants | 46 Participants | 41 Participants | 39 Participants | 46 Participants | 232 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 | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 75 | 0 / 50 | 0 / 75 | 0 / 75 | 0 / 75 | 1 / 75 |
| other Total, other adverse events | 37 / 75 | 6 / 50 | 27 / 75 | 26 / 75 | 31 / 75 | 24 / 75 |
| serious Total, serious adverse events | 0 / 75 | 3 / 50 | 5 / 75 | 6 / 75 | 4 / 75 | 6 / 75 |
Outcome results
Primary
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T-cells Expressing at Least 2 Markers
The frequency was expressed as the geometric mean of influenza-specific CD4 T-cells, expressing at least 2 markers among CD40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α) and Interferon-γ (IFN-γ ) upon in vitro stimulation.
Time frame: At Day 21
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available (subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination).
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Fluarix 18-40 Y Group | Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T-cells Expressing at Least 2 Markers | 3229.25 T-cells/million cells | Standard Deviation 1643.2 |
| Fluarix ≥65 Y Group | Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T-cells Expressing at Least 2 Markers | 1646.05 T-cells/million cells | Standard Deviation 1557.22 |
| Fluarix-AS25 Group | Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T-cells Expressing at Least 2 Markers | 3056.06 T-cells/million cells | Standard Deviation 2059.35 |
| Fluarix-AS50 Group | Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T-cells Expressing at Least 2 Markers | 2589.31 T-cells/million cells | Standard Deviation 2110.15 |
| Fluarix- AS01B Group | Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T-cells Expressing at Least 2 Markers | 2454.93 T-cells/million cells | Standard Deviation 1758.2 |
| Fluarix- AS01E Group | Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T-cells Expressing at Least 2 Markers | 2428.78 T-cells/million cells | Standard Deviation 2693.71 |
Comparison: Demonstration of non inferiority of the influenza adjuvanted vaccine Fluarix-AS25 administered to elderly subjects (aged 65 years and older) as compared to the licensed influenza vaccine Fluarix administered to adults (aged 18-40 years) in terms of frequency of influenza-specific CD4 T-cells producing at least 2 different cytokines (CD40L, IL-2, TNF-α or IFN-γ), 21 days post-vaccination.98.75% CI: [0.7, 1.16]
Comparison: Demonstration of non inferiority of the influenza adjuvanted vaccine Fluarix-AS50 administered to elderly subjects (aged 65 years and older) as compared to the licensed influenza vaccine Fluarix administered to adults (aged 18-40 years) in terms of frequency of influenza-specific CD4 T-cells producing at least 2 different cytokines (CD40L, IL-2, TNF-α or IFN-γ), 21 days post-vaccination.98.75% CI: [0.71, 1.56]
Comparison: Demonstration of non inferiority of the influenza adjuvanted vaccine Fluarix-AS01B administered to elderly subjects (aged 65 years and older) as compared to the licensed influenza vaccine Fluarix administered to adults (aged 18-40 years) in terms of frequency of influenza-specific CD4 T-cells producing at least 2 different cytokines (CD40L, IL-2, TNF-α or IFN-γ), 21 days post-vaccination.98.75% CI: [0.79, 1.38]
Comparison: Demonstration of non inferiority of the influenza adjuvanted vaccine Fluarix-AS01E administered to elderly subjects (aged 65 years and older) as compared to the licensed influenza vaccine Fluarix administered to adults (aged 18-40 years) in terms of frequency of influenza-specific CD4 T-cells producing at least 2 different cytokines (CD40L, IL-2, TNF-α or IFN-γ), 21 days post-vaccination.98.75% CI: [0.79, 1.44]
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 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).
Time frame: At Day 21
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available (subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix 18-40 Y Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | B/Jiangsu (B). | 61 Participants |
| Fluarix 18-40 Y Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | A/New York (H3N2) | 57 Participants |
| Fluarix 18-40 Y Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | A/New Caledonia (H1N1) | 58 Participants |
| Fluarix ≥65 Y Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | B/Jiangsu (B). | 22 Participants |
| Fluarix ≥65 Y Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | A/New Caledonia (H1N1) | 15 Participants |
| Fluarix ≥65 Y Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | A/New York (H3N2) | 34 Participants |
| Fluarix-AS25 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | B/Jiangsu (B). | 54 Participants |
| Fluarix-AS25 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | A/New Caledonia (H1N1) | 41 Participants |
| Fluarix-AS25 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | A/New York (H3N2) | 67 Participants |
| Fluarix-AS50 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | A/New Caledonia (H1N1) | 56 Participants |
| Fluarix-AS50 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | B/Jiangsu (B). | 50 Participants |
| Fluarix-AS50 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | A/New York (H3N2) | 62 Participants |
| Fluarix- AS01B Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | A/New York (H3N2) | 64 Participants |
| Fluarix- AS01B Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | A/New Caledonia (H1N1) | 36 Participants |
| Fluarix- AS01B Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | B/Jiangsu (B). | 49 Participants |
| Fluarix- AS01E Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | B/Jiangsu (B). | 53 Participants |
| Fluarix- AS01E Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | A/New Caledonia (H1N1) | 39 Participants |
| Fluarix- AS01E Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | A/New York (H3N2) | 60 Participants |
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 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).
Time frame: At Day 90 and Day 180
Population: The analysis was performed on the According-To-Protocol cohort for persistence included all subjects from the ATP cohort for immunogenicity who had not received any medication or vaccine forbidden by the protocol during the study period and who had available assay results for at least 1 tested antigen at the Day 90 or Day 180 time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix 18-40 Y Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | A/New York, Day 180 | 48 Participants |
| Fluarix 18-40 Y Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | A/New Caledonia, Day 180 | 54 Participants |
| Fluarix 18-40 Y Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | B/Jiangsu, Day 180 | 45 Participants |
| Fluarix 18-40 Y Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | A/New York, Day 90 | 55 Participants |
| Fluarix 18-40 Y Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | A/New Caledonia, Day 90 | 56 Participants |
| Fluarix 18-40 Y Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | B/Jiangsu, Day 90 | 53 Participants |
| Fluarix ≥65 Y Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | B/Jiangsu, Day 180 | 16 Participants |
| Fluarix ≥65 Y Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | A/New Caledonia, Day 180 | 10 Participants |
| Fluarix ≥65 Y Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | B/Jiangsu, Day 90 | 16 Participants |
| Fluarix ≥65 Y Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | A/New York, Day 180 | 17 Participants |
| Fluarix ≥65 Y Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | A/New Caledonia, Day 90 | 16 Participants |
| Fluarix ≥65 Y Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | A/New York, Day 90 | 29 Participants |
| Fluarix-AS25 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | A/New York, Day 180 | 40 Participants |
| Fluarix-AS25 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | A/New Caledonia, Day 90 | 32 Participants |
| Fluarix-AS25 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | A/New Caledonia, Day 180 | 20 Participants |
| Fluarix-AS25 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | B/Jiangsu, Day 180 | 28 Participants |
| Fluarix-AS25 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | A/New York, Day 90 | 56 Participants |
| Fluarix-AS25 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | B/Jiangsu, Day 90 | 38 Participants |
| Fluarix-AS50 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | A/New Caledonia, Day 90 | 38 Participants |
| Fluarix-AS50 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | A/New Caledonia, Day 180 | 25 Participants |
| Fluarix-AS50 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | A/New York, Day 90 | 55 Participants |
| Fluarix-AS50 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | A/New York, Day 180 | 40 Participants |
| Fluarix-AS50 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | B/Jiangsu, Day 90 | 44 Participants |
| Fluarix-AS50 Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | B/Jiangsu, Day 180 | 33 Participants |
| Fluarix- AS01B Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | A/New Caledonia, Day 180 | 16 Participants |
| Fluarix- AS01B Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | B/Jiangsu, Day 180 | 26 Participants |
| Fluarix- AS01B Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | A/New Caledonia, Day 90 | 25 Participants |
| Fluarix- AS01B Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | B/Jiangsu, Day 90 | 33 Participants |
| Fluarix- AS01B Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | A/New York, Day 180 | 35 Participants |
| Fluarix- AS01B Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | A/New York, Day 90 | 47 Participants |
| Fluarix- AS01E Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | A/New York, Day 180 | 35 Participants |
| Fluarix- AS01E Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | A/New Caledonia, Day 180 | 15 Participants |
| Fluarix- AS01E Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | B/Jiangsu, Day 90 | 44 Participants |
| Fluarix- AS01E Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | A/New Caledonia, Day 90 | 28 Participants |
| Fluarix- AS01E Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | B/Jiangsu, Day 180 | 25 Participants |
| Fluarix- AS01E Group | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease | A/New York, Day 90 | 48 Participants |
Secondary
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).
Time frame: At Day 0 and at Day 21
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available (subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix 18-40 Y Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | B/Jiangsu, Day 0 | 35 Participants |
| Fluarix 18-40 Y Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | B/Jiangsu, Day 21 | 75 Participants |
| Fluarix 18-40 Y Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New York, Day 21 | 70 Participants |
| Fluarix 18-40 Y Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New York, Day 0 | 24 Participants |
| Fluarix 18-40 Y Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New Caledonia, Day 0 | 27 Participants |
| Fluarix 18-40 Y Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New Caledonia, Day 21 | 75 Participants |
| Fluarix ≥65 Y Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New Caledonia, Day 0 | 18 Participants |
| Fluarix ≥65 Y Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New Caledonia, Day 21 | 35 Participants |
| Fluarix ≥65 Y Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | B/Jiangsu, Day 21 | 46 Participants |
| Fluarix ≥65 Y Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New York, Day 0 | 9 Participants |
| Fluarix ≥65 Y Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New York, Day 21 | 40 Participants |
| Fluarix ≥65 Y Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | B/Jiangsu, Day 0 | 23 Participants |
| Fluarix-AS25 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New Caledonia, Day 21 | 67 Participants |
| Fluarix-AS25 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | B/Jiangsu, Day 21 | 71 Participants |
| Fluarix-AS25 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New Caledonia, Day 0 | 32 Participants |
| Fluarix-AS25 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New York, Day 0 | 16 Participants |
| Fluarix-AS25 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New York, Day 21 | 70 Participants |
| Fluarix-AS25 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | B/Jiangsu, Day 0 | 37 Participants |
| Fluarix-AS50 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New Caledonia, Day 0 | 33 Participants |
| Fluarix-AS50 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New Caledonia, Day 21 | 74 Participants |
| Fluarix-AS50 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | B/Jiangsu, Day 0 | 40 Participants |
| Fluarix-AS50 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New York, Day 0 | 24 Participants |
| Fluarix-AS50 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | B/Jiangsu, Day 21 | 74 Participants |
| Fluarix-AS50 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New York, Day 21 | 70 Participants |
| Fluarix- AS01B Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New Caledonia, Day 0 | 41 Participants |
| Fluarix- AS01B Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New York, Day 0 | 24 Participants |
| Fluarix- AS01B Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New Caledonia, Day 21 | 73 Participants |
| Fluarix- AS01B Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New York, Day 21 | 72 Participants |
| Fluarix- AS01B Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | B/Jiangsu, Day 0 | 45 Participants |
| Fluarix- AS01B Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | B/Jiangsu, Day 21 | 75 Participants |
| Fluarix- AS01E Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New Caledonia, Day 0 | 41 Participants |
| Fluarix- AS01E Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | B/Jiangsu, Day 21 | 73 Participants |
| Fluarix- AS01E Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New York, Day 21 | 70 Participants |
| Fluarix- AS01E Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New York, Day 0 | 23 Participants |
| Fluarix- AS01E Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New Caledonia, Day 21 | 70 Participants |
| Fluarix- AS01E Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | B/Jiangsu, Day 0 | 40 Participants |
Secondary
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).
Time frame: At Day 90 and Day 180
Population: The analysis was performed on the According-To-Protocol cohort for persistence included all subjects from the ATP cohort for immunogenicity who had not received any medication or vaccine forbidden by the protocol during the study period and who had available assay results for at least 1 tested antigen at the Day 90 or Day 180 time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix 18-40 Y Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New Caledonia, Day 90 | 75 Participants |
| Fluarix 18-40 Y Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New Caledonia, Day 180 | 72 Participants |
| Fluarix 18-40 Y Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New York, Day 90 | 68 Participants |
| Fluarix 18-40 Y Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New York, Day 180 | 64 Participants |
| Fluarix 18-40 Y Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | B/Jiangsu, Day 90 | 71 Participants |
| Fluarix 18-40 Y Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | B/Jiangsu, Day 180 | 67 Participants |
| Fluarix ≥65 Y Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New Caledonia, Day 180 | 34 Participants |
| Fluarix ≥65 Y Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New York, Day 180 | 28 Participants |
| Fluarix ≥65 Y Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | B/Jiangsu, Day 180 | 41 Participants |
| Fluarix ≥65 Y Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New Caledonia, Day 90 | 37 Participants |
| Fluarix ≥65 Y Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New York, Day 90 | 35 Participants |
| Fluarix ≥65 Y Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | B/Jiangsu, Day 90 | 47 Participants |
| Fluarix-AS25 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | B/Jiangsu, Day 180 | 63 Participants |
| Fluarix-AS25 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | B/Jiangsu, Day 90 | 66 Participants |
| Fluarix-AS25 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New York, Day 180 | 54 Participants |
| Fluarix-AS25 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New York, Day 90 | 64 Participants |
| Fluarix-AS25 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New Caledonia, Day 90 | 66 Participants |
| Fluarix-AS25 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New Caledonia, Day 180 | 58 Participants |
| Fluarix-AS50 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New York, Day 180 | 58 Participants |
| Fluarix-AS50 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New Caledonia, Day 180 | 62 Participants |
| Fluarix-AS50 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New York, Day 90 | 67 Participants |
| Fluarix-AS50 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | B/Jiangsu, Day 180 | 70 Participants |
| Fluarix-AS50 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | B/Jiangsu, Day 90 | 72 Participants |
| Fluarix-AS50 Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New Caledonia, Day 90 | 68 Participants |
| Fluarix- AS01B Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New Caledonia, Day 90 | 71 Participants |
| Fluarix- AS01B Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | B/Jiangsu, Day 90 | 72 Participants |
| Fluarix- AS01B Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New Caledonia, Day 180 | 60 Participants |
| Fluarix- AS01B Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New York, Day 90 | 62 Participants |
| Fluarix- AS01B Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New York, Day 180 | 54 Participants |
| Fluarix- AS01B Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | B/Jiangsu, Day 180 | 69 Participants |
| Fluarix- AS01E Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New York, Day 180 | 54 Participants |
| Fluarix- AS01E Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New York, Day 90 | 65 Participants |
| Fluarix- AS01E Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | B/Jiangsu, Day 90 | 67 Participants |
| Fluarix- AS01E Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | B/Jiangsu, Day 180 | 63 Participants |
| Fluarix- AS01E Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New Caledonia, Day 180 | 62 Participants |
| Fluarix- AS01E Group | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease | A/New Caledonia, Day 90 | 69 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Assessed solicited local symptoms were haematoma, pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain which prevented normal everyday activity. Grade 3 haematoma/redness/swelling = haematoma/redness/swelling spreading beyond 50 millimeters (mm).
Time frame: During the 7-day (Days 0-6) follow-up period after vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects who received the vaccine dose.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix 18-40 Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Redness, Any | 12 Participants |
| Fluarix 18-40 Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Haematoma, Any | 3 Participants |
| Fluarix 18-40 Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Pain, Grade 3 | 0 Participants |
| Fluarix 18-40 Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Redness, > 50 mm | 0 Participants |
| Fluarix 18-40 Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Swelling, Any | 9 Participants |
| Fluarix 18-40 Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Pain, Any | 58 Participants |
| Fluarix 18-40 Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Haematoma, > 50 mm | 0 Participants |
| Fluarix 18-40 Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Swelling, > 50 mm | 0 Participants |
| Fluarix ≥65 Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Haematoma, > 50 mm | 0 Participants |
| Fluarix ≥65 Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Swelling, > 50 mm | 0 Participants |
| Fluarix ≥65 Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Pain, Grade 3 | 0 Participants |
| Fluarix ≥65 Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Swelling, Any | 1 Participants |
| Fluarix ≥65 Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Redness, Any | 5 Participants |
| Fluarix ≥65 Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Redness, > 50 mm | 0 Participants |
| Fluarix ≥65 Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Haematoma, Any | 2 Participants |
| Fluarix ≥65 Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Pain, Any | 8 Participants |
| Fluarix-AS25 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Swelling, Any | 14 Participants |
| Fluarix-AS25 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Swelling, > 50 mm | 5 Participants |
| Fluarix-AS25 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Haematoma, > 50 mm | 1 Participants |
| Fluarix-AS25 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Pain, Any | 53 Participants |
| Fluarix-AS25 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Haematoma, Any | 4 Participants |
| Fluarix-AS25 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Pain, Grade 3 | 1 Participants |
| Fluarix-AS25 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Redness, Any | 11 Participants |
| Fluarix-AS25 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Redness, > 50 mm | 3 Participants |
| Fluarix-AS50 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Haematoma, Any | 4 Participants |
| Fluarix-AS50 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Pain, Any | 54 Participants |
| Fluarix-AS50 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Redness, Any | 22 Participants |
| Fluarix-AS50 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Haematoma, > 50 mm | 0 Participants |
| Fluarix-AS50 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Swelling, Any | 15 Participants |
| Fluarix-AS50 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Redness, > 50 mm | 9 Participants |
| Fluarix-AS50 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Swelling, > 50 mm | 6 Participants |
| Fluarix-AS50 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Pain, Grade 3 | 1 Participants |
| Fluarix- AS01B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Redness, > 50 mm | 5 Participants |
| Fluarix- AS01B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Pain, Any | 51 Participants |
| Fluarix- AS01B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Haematoma, Any | 6 Participants |
| Fluarix- AS01B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Swelling, Any | 12 Participants |
| Fluarix- AS01B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Pain, Grade 3 | 2 Participants |
| Fluarix- AS01B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Redness, Any | 17 Participants |
| Fluarix- AS01B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Swelling, > 50 mm | 4 Participants |
| Fluarix- AS01B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Haematoma, > 50 mm | 0 Participants |
| Fluarix- AS01E Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Redness, Any | 11 Participants |
| Fluarix- AS01E Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Haematoma, Any | 1 Participants |
| Fluarix- AS01E Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Haematoma, > 50 mm | 0 Participants |
| Fluarix- AS01E Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Pain, Any | 42 Participants |
| Fluarix- AS01E Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Pain, Grade 3 | 0 Participants |
| Fluarix- AS01E Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Redness, > 50 mm | 4 Participants |
| Fluarix- AS01E Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Swelling, Any | 9 Participants |
| Fluarix- AS01E Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Swelling, > 50 mm | 3 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Assessed solicited general symptoms were fatigue, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], headache, joint pain, muscle aches and shivering. Any = occurrence of any general symptom regardless of intensity grade and relationship to vaccination. Grade 3 = symptoms that prevented normal activity. Grade 3 fever = fever \>39°C. Related = general symptom assessed by the investigator as causally related to the study vaccination.
Time frame: During the 7-day (Days 0-6) follow-up period after vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects who received the vaccine dose.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix 18-40 Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (axillary), Any | 2 Participants |
| Fluarix 18-40 Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fatigue, Related | 26 Participants |
| Fluarix 18-40 Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Headache, Grade 3 | 0 Participants |
| Fluarix 18-40 Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Shivering, Any | 6 Participants |
| Fluarix 18-40 Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Muscle aches, Related | 11 Participants |
| Fluarix 18-40 Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Muscle aches, Any | 14 Participants |
| Fluarix 18-40 Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Muscle aches, Grade 3 | 0 Participants |
| Fluarix 18-40 Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (axillary), Grade 3 | 0 Participants |
| Fluarix 18-40 Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Shivering, Related | 4 Participants |
| Fluarix 18-40 Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fatigue, Any | 34 Participants |
| Fluarix 18-40 Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Joint pain, Related | 4 Participants |
| Fluarix 18-40 Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Joint pain, Grade 3 | 0 Participants |
| Fluarix 18-40 Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fatigue, Grade 3 | 1 Participants |
| Fluarix 18-40 Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Shivering, Grade 3 | 0 Participants |
| Fluarix 18-40 Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (axillary), Related | 2 Participants |
| Fluarix 18-40 Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Joint pain, Any | 5 Participants |
| Fluarix 18-40 Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Headache, Related | 17 Participants |
| Fluarix 18-40 Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Headache, Any | 24 Participants |
| Fluarix ≥65 Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (axillary), Any | 0 Participants |
| Fluarix ≥65 Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fatigue, Related | 7 Participants |
| Fluarix ≥65 Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fatigue, Any | 7 Participants |
| Fluarix ≥65 Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Muscle aches, Grade 3 | 0 Participants |
| Fluarix ≥65 Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Headache, Grade 3 | 0 Participants |
| Fluarix ≥65 Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Joint pain, Any | 4 Participants |
| Fluarix ≥65 Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Joint pain, Grade 3 | 0 Participants |
| Fluarix ≥65 Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Muscle aches, Any | 3 Participants |
| Fluarix ≥65 Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Muscle aches, Related | 2 Participants |
| Fluarix ≥65 Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Shivering, Any | 3 Participants |
| Fluarix ≥65 Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Headache, Related | 8 Participants |
| Fluarix ≥65 Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (axillary), Grade 3 | 0 Participants |
| Fluarix ≥65 Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Shivering, Grade 3 | 0 Participants |
| Fluarix ≥65 Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fatigue, Grade 3 | 0 Participants |
| Fluarix ≥65 Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Joint pain, Related | 2 Participants |
| Fluarix ≥65 Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Headache, Any | 12 Participants |
| Fluarix ≥65 Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Shivering, Related | 2 Participants |
| Fluarix ≥65 Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (axillary), Related | 0 Participants |
| Fluarix-AS25 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Joint pain, Related | 17 Participants |
| Fluarix-AS25 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Muscle aches, Grade 3 | 1 Participants |
| Fluarix-AS25 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Muscle aches, Related | 24 Participants |
| Fluarix-AS25 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Shivering, Any | 18 Participants |
| Fluarix-AS25 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fatigue, Any | 31 Participants |
| Fluarix-AS25 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fatigue, Grade 3 | 2 Participants |
| Fluarix-AS25 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (axillary), Related | 4 Participants |
| Fluarix-AS25 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Headache, Any | 28 Participants |
| Fluarix-AS25 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Headache, Grade 3 | 1 Participants |
| Fluarix-AS25 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Muscle aches, Any | 25 Participants |
| Fluarix-AS25 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fatigue, Related | 27 Participants |
| Fluarix-AS25 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Headache, Related | 26 Participants |
| Fluarix-AS25 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (axillary), Any | 4 Participants |
| Fluarix-AS25 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Joint pain, Any | 19 Participants |
| Fluarix-AS25 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Joint pain, Grade 3 | 1 Participants |
| Fluarix-AS25 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (axillary), Grade 3 | 1 Participants |
| Fluarix-AS25 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Shivering, Grade 3 | 1 Participants |
| Fluarix-AS25 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Shivering, Related | 18 Participants |
| Fluarix-AS50 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Headache, Related | 25 Participants |
| Fluarix-AS50 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fatigue, Related | 34 Participants |
| Fluarix-AS50 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Shivering, Grade 3 | 2 Participants |
| Fluarix-AS50 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Headache, Grade 3 | 1 Participants |
| Fluarix-AS50 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fatigue, Any | 34 Participants |
| Fluarix-AS50 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Joint pain, Related | 12 Participants |
| Fluarix-AS50 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fatigue, Grade 3 | 1 Participants |
| Fluarix-AS50 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Muscle aches, Grade 3 | 1 Participants |
| Fluarix-AS50 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Joint pain, Any | 13 Participants |
| Fluarix-AS50 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (axillary), Grade 3 | 1 Participants |
| Fluarix-AS50 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Joint pain, Grade 3 | 0 Participants |
| Fluarix-AS50 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Headache, Any | 27 Participants |
| Fluarix-AS50 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Shivering, Related | 20 Participants |
| Fluarix-AS50 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Muscle aches, Related | 25 Participants |
| Fluarix-AS50 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (axillary), Related | 5 Participants |
| Fluarix-AS50 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Shivering, Any | 21 Participants |
| Fluarix-AS50 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Muscle aches, Any | 25 Participants |
| Fluarix-AS50 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (axillary), Any | 6 Participants |
| Fluarix- AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Shivering, Any | 27 Participants |
| Fluarix- AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Headache, Any | 21 Participants |
| Fluarix- AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Headache, Grade 3 | 1 Participants |
| Fluarix- AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fatigue, Related | 31 Participants |
| Fluarix- AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (axillary), Related | 7 Participants |
| Fluarix- AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Shivering, Related | 27 Participants |
| Fluarix- AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (axillary), Any | 7 Participants |
| Fluarix- AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Headache, Related | 20 Participants |
| Fluarix- AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fatigue, Grade 3 | 5 Participants |
| Fluarix- AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Shivering, Grade 3 | 3 Participants |
| Fluarix- AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Joint pain, Any | 23 Participants |
| Fluarix- AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fatigue, Any | 31 Participants |
| Fluarix- AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Joint pain, Grade 3 | 1 Participants |
| Fluarix- AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (axillary), Grade 3 | 0 Participants |
| Fluarix- AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Joint pain, Related | 20 Participants |
| Fluarix- AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Muscle aches, Related | 25 Participants |
| Fluarix- AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Muscle aches, Any | 26 Participants |
| Fluarix- AS01B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Muscle aches, Grade 3 | 3 Participants |
| Fluarix- AS01E Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Shivering, Grade 3 | 2 Participants |
| Fluarix- AS01E Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (axillary), Any | 4 Participants |
| Fluarix- AS01E Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Joint pain, Related | 14 Participants |
| Fluarix- AS01E Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (axillary), Related | 4 Participants |
| Fluarix- AS01E Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fatigue, Related | 19 Participants |
| Fluarix- AS01E Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fatigue, Grade 3 | 1 Participants |
| Fluarix- AS01E Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (axillary), Grade 3 | 0 Participants |
| Fluarix- AS01E Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Muscle aches, Grade 3 | 2 Participants |
| Fluarix- AS01E Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Muscle aches, Any | 21 Participants |
| Fluarix- AS01E Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Headache, Any | 14 Participants |
| Fluarix- AS01E Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Headache, Grade 3 | 0 Participants |
| Fluarix- AS01E Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fatigue, Any | 22 Participants |
| Fluarix- AS01E Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Muscle aches, Related | 18 Participants |
| Fluarix- AS01E Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Shivering, Related | 13 Participants |
| Fluarix- AS01E Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Joint pain, Any | 17 Participants |
| Fluarix- AS01E Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Shivering, Any | 13 Participants |
| Fluarix- AS01E Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Joint pain, Grade 3 | 1 Participants |
| Fluarix- AS01E Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Headache, Related | 14 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 =event that prevented normal everyday activity. Related = event assessed by the investigator as causally related to the study vaccination.
Time frame: During the 21-day (Days 0-20) follow-up period after vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects who received the vaccine dose.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix 18-40 Y Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Grade 3 AEs | 1 Participants |
| Fluarix 18-40 Y Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Any AEs | 37 Participants |
| Fluarix 18-40 Y Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Related AEs | 11 Participants |
| Fluarix ≥65 Y Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Related AEs | 2 Participants |
| Fluarix ≥65 Y Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Any AEs | 6 Participants |
| Fluarix ≥65 Y Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Grade 3 AEs | 0 Participants |
| Fluarix-AS25 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Related AEs | 9 Participants |
| Fluarix-AS25 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Grade 3 AEs | 4 Participants |
| Fluarix-AS25 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Any AEs | 27 Participants |
| Fluarix-AS50 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Any AEs | 26 Participants |
| Fluarix-AS50 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Grade 3 AEs | 6 Participants |
| Fluarix-AS50 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Related AEs | 14 Participants |
| Fluarix- AS01B Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Related AEs | 18 Participants |
| Fluarix- AS01B Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Any AEs | 31 Participants |
| Fluarix- AS01B Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Grade 3 AEs | 4 Participants |
| Fluarix- AS01E Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Related AEs | 5 Participants |
| Fluarix- AS01E Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Any AEs | 24 Participants |
| Fluarix- AS01E Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Grade 3 AEs | 3 Participants |
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 or result in disability/incapacity.
Time frame: During the entire study period (Day 0 - Day 180)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects who received the vaccine dose.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fluarix 18-40 Y Group | Number of Subjects With Serious Adverse Events (SAEs). | 0 Participants |
| Fluarix ≥65 Y Group | Number of Subjects With Serious Adverse Events (SAEs). | 3 Participants |
| Fluarix-AS25 Group | Number of Subjects With Serious Adverse Events (SAEs). | 5 Participants |
| Fluarix-AS50 Group | Number of Subjects With Serious Adverse Events (SAEs). | 6 Participants |
| Fluarix- AS01B Group | Number of Subjects With Serious Adverse Events (SAEs). | 4 Participants |
| Fluarix- AS01E Group | Number of Subjects With Serious Adverse Events (SAEs). | 6 Participants |
Secondary
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease
The seroconversion factor (SCF) was defined as the fold change in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to pre-vaccination time point. The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).
Time frame: At Day 90 and Day 180
Population: The analysis was performed on the According-To-Protocol cohort for persistence included all subjects from the ATP cohort for immunogenicity who had not received any medication or vaccine forbidden by the protocol during the study period and who had available assay results for at least 1 tested antigen at the Day 90 or Day 180 time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluarix 18-40 Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New York, Day 90 | 7.9 Fold change |
| Fluarix 18-40 Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia, Day 90 | 23.9 Fold change |
| Fluarix 18-40 Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu, Day 90 | 8.3 Fold change |
| Fluarix 18-40 Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu, Day 180 | 5.4 Fold change |
| Fluarix 18-40 Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New York, Day 180 | 5.8 Fold change |
| Fluarix 18-40 Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia, Day 180 | 17.1 Fold change |
| Fluarix ≥65 Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New York, Day 180 | 3.7 Fold change |
| Fluarix ≥65 Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu, Day 90 | 4.2 Fold change |
| Fluarix ≥65 Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia, Day 90 | 3.3 Fold change |
| Fluarix ≥65 Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New York, Day 90 | 5.1 Fold change |
| Fluarix ≥65 Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia, Day 180 | 2.7 Fold change |
| Fluarix ≥65 Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu, Day 180 | 3 Fold change |
| Fluarix-AS25 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu, Day 90 | 5.3 Fold change |
| Fluarix-AS25 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New York, Day 90 | 7.6 Fold change |
| Fluarix-AS25 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New York, Day 180 | 5.1 Fold change |
| Fluarix-AS25 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia, Day 180 | 2.8 Fold change |
| Fluarix-AS25 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu, Day 180 | 3.3 Fold change |
| Fluarix-AS25 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia, Day 90 | 3.9 Fold change |
| Fluarix-AS50 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia, Day 90 | 5.7 Fold change |
| Fluarix-AS50 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu, Day 180 | 3.3 Fold change |
| Fluarix-AS50 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New York, Day 180 | 4.5 Fold change |
| Fluarix-AS50 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu, Day 90 | 5.6 Fold change |
| Fluarix-AS50 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New York, Day 90 | 7.3 Fold change |
| Fluarix-AS50 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia, Day 180 | 3.7 Fold change |
| Fluarix- AS01B Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu, Day 90 | 3.7 Fold change |
| Fluarix- AS01B Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia, Day 90 | 2.9 Fold change |
| Fluarix- AS01B Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New York, Day 90 | 6.2 Fold change |
| Fluarix- AS01B Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New York, Day 180 | 3.9 Fold change |
| Fluarix- AS01B Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia, Day 180 | 2.1 Fold change |
| Fluarix- AS01B Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu, Day 180 | 2.8 Fold change |
| Fluarix- AS01E Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu, Day 180 | 3.1 Fold change |
| Fluarix- AS01E Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu, Day 90 | 4.8 Fold change |
| Fluarix- AS01E Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New York, Day 90 | 6.6 Fold change |
| Fluarix- AS01E Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia, Day 90 | 3.1 Fold change |
| Fluarix- AS01E Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia, Day 180 | 2.4 Fold change |
| Fluarix- AS01E Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New York, Day 180 | 4.1 Fold change |
Secondary
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease
The seroconversion factor (SCF) was defined as the fold change in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to pre-vaccination time point. The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B).
Time frame: At Day 21
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available (subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluarix 18-40 Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New York | 9.2 Fold change |
| Fluarix 18-40 Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia | 35.1 Fold change |
| Fluarix 18-40 Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu | 13.9 Fold change |
| Fluarix ≥65 Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New York | 8.2 Fold change |
| Fluarix ≥65 Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia | 3.7 Fold change |
| Fluarix ≥65 Y Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu | 4.3 Fold change |
| Fluarix-AS25 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New York | 19.2 Fold change |
| Fluarix-AS25 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia | 6.4 Fold change |
| Fluarix-AS25 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu | 8.5 Fold change |
| Fluarix-AS50 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New York | 15.0 Fold change |
| Fluarix-AS50 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia | 9.2 Fold change |
| Fluarix-AS50 Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu | 7.6 Fold change |
| Fluarix- AS01B Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New York | 13.1 Fold change |
| Fluarix- AS01B Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia | 4.5 Fold change |
| Fluarix- AS01B Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu | 5.2 Fold change |
| Fluarix- AS01E Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia | 5.0 Fold change |
| Fluarix- AS01E Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu | 6.7 Fold change |
| Fluarix- AS01E Group | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New York | 14.5 Fold change |
Secondary
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B). Seropositivity was defined as a serum HI titer greater than or equal to (≥) 1:10.
Time frame: At Day 0 and at Day 21
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available (subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluarix 18-40 Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New York, Day 0 | 16.5 Titers |
| Fluarix 18-40 Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu, Day 0 | 25.2 Titers |
| Fluarix 18-40 Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia, Day 21 | 728.4 Titers |
| Fluarix 18-40 Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu, Day 21 | 349.5 Titers |
| Fluarix 18-40 Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia, Day 0 | 20.7 Titers |
| Fluarix 18-40 Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New York, Day 21 | 151.3 Titers |
| Fluarix ≥65 Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New York, Day 21 | 98.9 Titers |
| Fluarix ≥65 Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New York, Day 0 | 12.0 Titers |
| Fluarix ≥65 Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia, Day 0 | 23.5 Titers |
| Fluarix ≥65 Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu, Day 21 | 134.1 Titers |
| Fluarix ≥65 Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu, Day 0 | 31.4 Titers |
| Fluarix ≥65 Y Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia, Day 21 | 86.5 Titers |
| Fluarix-AS25 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New York, Day 0 | 13.0 Titers |
| Fluarix-AS25 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia, Day 0 | 23.9 Titers |
| Fluarix-AS25 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia, Day 21 | 151.9 Titers |
| Fluarix-AS25 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New York, Day 21 | 249.7 Titers |
| Fluarix-AS25 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu, Day 0 | 27.7 Titers |
| Fluarix-AS25 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu, Day 21 | 237.1 Titers |
| Fluarix-AS50 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia, Day 0 | 24.1 Titers |
| Fluarix-AS50 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu, Day 21 | 293.1 Titers |
| Fluarix-AS50 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New York, Day 21 | 240.3 Titers |
| Fluarix-AS50 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu, Day 0 | 38.7 Titers |
| Fluarix-AS50 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia, Day 21 | 223.2 Titers |
| Fluarix-AS50 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New York, Day 0 | 16.0 Titers |
| Fluarix- AS01B Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia, Day 21 | 151.4 Titers |
| Fluarix- AS01B Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New York, Day 21 | 202.5 Titers |
| Fluarix- AS01B Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia, Day 0 | 33.9 Titers |
| Fluarix- AS01B Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu, Day 21 | 205.4 Titers |
| Fluarix- AS01B Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu, Day 0 | 39.2 Titers |
| Fluarix- AS01B Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New York, Day 0 | 15.5 Titers |
| Fluarix- AS01E Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia, Day 0 | 33.5 Titers |
| Fluarix- AS01E Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New York, Day 21 | 249.3 Titers |
| Fluarix- AS01E Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu, Day 21 | 202.6 Titers |
| Fluarix- AS01E Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia, Day 21 | 166.8 Titers |
| Fluarix- AS01E Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | A/New York, Day 0 | 17.2 Titers |
| Fluarix- AS01E Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu, Day 0 | 30.0 Titers |
Secondary
Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia (H1N1), A/New York (H3N2) and B/Jiangsu (B). Seropositivity was defined as a serum HI titer of ≥ 1:10.
Time frame: At Day 90 and Day 180
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence included all subjects from the ATP cohort for immunogenicity who had not received any medication or vaccine forbidden by the protocol during the study period and who had available assay results for at least 1 tested antigen at the Day 90 or Day 180 time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluarix 18-40 Y Group | Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu, Day 180 | 140.3 Titers |
| Fluarix 18-40 Y Group | Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia, Day 180 | 354.7 Titers |
| Fluarix 18-40 Y Group | Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia, Day 90 | 496.4 Titers |
| Fluarix 18-40 Y Group | Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease | A/New York, Day 90 | 130.5 Titers |
| Fluarix 18-40 Y Group | Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease | A/New York, Day 180 | 96.5 Titers |
| Fluarix 18-40 Y Group | Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu, Day 90 | 208.2 Titers |
| Fluarix ≥65 Y Group | Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu, Day 90 | 131.3 Titers |
| Fluarix ≥65 Y Group | Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease | A/New York, Day 90 | 60.7 Titers |
| Fluarix ≥65 Y Group | Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease | A/New York, Day 180 | 43.8 Titers |
| Fluarix ≥65 Y Group | Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia, Day 180 | 62.9 Titers |
| Fluarix ≥65 Y Group | Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia, Day 90 | 76.7 Titers |
| Fluarix ≥65 Y Group | Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu, Day 180 | 94.5 Titers |
| Fluarix-AS25 Group | Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia, Day 180 | 66.9 Titers |
| Fluarix-AS25 Group | Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu, Day 90 | 145.6 Titers |
| Fluarix-AS25 Group | Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease | A/New York, Day 180 | 66.3 Titers |
| Fluarix-AS25 Group | Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu, Day 180 | 91.6 Titers |
| Fluarix-AS25 Group | Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia, Day 90 | 94.2 Titers |
| Fluarix-AS25 Group | Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease | A/New York, Day 90 | 99.2 Titers |
| Fluarix-AS50 Group | Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu, Day 180 | 128.0 Titers |
| Fluarix-AS50 Group | Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia, Day 180 | 89.1 Titers |
| Fluarix-AS50 Group | Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease | A/New York, Day 180 | 71.8 Titers |
| Fluarix-AS50 Group | Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease | A/New York, Day 90 | 116.4 Titers |
| Fluarix-AS50 Group | Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu, Day 90 | 213.0 Titers |
| Fluarix-AS50 Group | Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia, Day 90 | 135.3 Titers |
| Fluarix- AS01B Group | Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia, Day 90 | 97.4 Titers |
| Fluarix- AS01B Group | Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia, Day 180 | 70.5 Titers |
| Fluarix- AS01B Group | Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease | A/New York, Day 90 | 93.3 Titers |
| Fluarix- AS01B Group | Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease | A/New York, Day 180 | 59.5 Titers |
| Fluarix- AS01B Group | Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu, Day 90 | 147.1 Titers |
| Fluarix- AS01B Group | Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu, Day 180 | 111.0 Titers |
| Fluarix- AS01E Group | Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease | A/New York, Day 180 | 70.4 Titers |
| Fluarix- AS01E Group | Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease | A/New York, Day 90 | 114.8 Titers |
| Fluarix- AS01E Group | Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia, Day 180 | 81.9 Titers |
| Fluarix- AS01E Group | Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease | A/New Caledonia, Day 90 | 105.9 Titers |
| Fluarix- AS01E Group | Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu, Day 180 | 91.4 Titers |
| Fluarix- AS01E Group | Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease | B/Jiangsu, Day 90 | 144.2 Titers |