Influenza
Conditions
Keywords
Fluarix, GSK Bio's influenza vaccine GSK576389A, Influenza infection
Brief summary
Since influenza vaccines are administered every year because of the frequent change in their antigenic composition, the safety and immunogenicity profile of GSK Biologicals' influenza vaccine GSK576389A will be re-evaluated after repeated vaccine administration. In this observer blind study, the subjects previously enrolled in study 104888 (NCT00377585) will receive a dose with the 2007-2008 season's formulations of Fluarix or GSK576389A. Only subjects who were previously enrolled in study 104888 (NCT00377585) are eligible for participation in this study.
Detailed description
This study involves 2 age groups (based on primary study): Subjects enrolled in the \>= 65 yrs age group in the primary study. Subjects enrolled in the 18-40 yrs age group in the primary study. The study will be conducted in an open manner for this age group. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Interventions
BIOLOGICALFluarix
Single dose, Intramuscular injection
BIOLOGICALGSK Biologicals Influenza Vaccine GSK576389A
Single dose, Intramuscular injection
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study. * Written informed consent obtained from the subject. * Free of an acute aggravation of the health status as established by clinical evaluation before entering into the study. * If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series. * Male or female subjects who participated in the 104888 study (NCT00377585) and were enrolled in the \>= 65 years age group or in the 18-40 years age group .
Exclusion criteria
* Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. * Planned administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination * Planned administration of an influenza vaccine other than the study vaccines during the entire study period * Any vaccination against influenza since January 2007 * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * History of hypersensitivity to a previous dose of influenza vaccine * History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) * Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or pre-existing laboratory screening tests * Acute disease at the time of enrolment * Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to vaccination, or planned use during the study period * Any medical conditions in which IM injections are contraindicated * Pregnant or lactating female, or planning to become pregnant or to discontinue contraceptive precautions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | During a 7-day follow-up period after vaccination | Solicited local AEs assessed include ecchymosis, pain, redness and swelling. Any: any symptom regardless of intensity grade. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter. |
| Duration of Solicited Local Adverse Events | During a 7-day follow-up period after vaccination | Duration was expressed as the median number of days the symptom was experienced. |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | During a 7-day follow-up period after vaccination | Solicited general AEs assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C). Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 40°C. Related: symptom assessed by the investigator as causally related to the study vaccination. |
| Duration of Solicited General Adverse Events | During a 7-day follow-up period after vaccination | Duration was expressed as the median number of days the symptom was experienced. |
| Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | During a 21-day follow-up period after vaccination | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any: any AE regardless of intensity or relationship to vaccination. Grade 3: AE that prevented normal activity. Related: AE considered by the investigator to be causally related to the study vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains | At Days 0 and 21 | A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to1:40 that is usually accepted as indicating protection. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. |
| Number of Cluster of Differentiation 4 (CD4) T-cells (Per Million CD4 T-cells) Producing at Least 2 Different Immune Markers | At Day 0 and 21 | Results are presented as the geometric mean number of immune response marker-positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ). |
| Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least CD40L and Another Immune Marker | At Day 0 and 21 | Results are presented as the geometric mean number of CD40L-positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ). |
| Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IFN-γ and Another Immune Marker | At Day 0 and 21 | Results are presented as the geometric mean number of IFN-γ -positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α). |
| Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IL-2 and Another Immune Marker | At Day 0 and 21 | Results are presented as the geometric mean number of IFN-γ -positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ). |
| Number of Subjects With Any and Related Serious Adverse Events (SAEs) | During the vaccination phase of the study (Day 0 to Day 20) and during the long term follow-up phase of the study (Day 21 to Day 179) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. |
| Number of Cluster of Differentiation 8 (CD8) T-cells (Per Million CD8 T-cells) Expressing at Least 2 Different Immune Markers | At Day 0 and 21 | Results are presented as the geometric mean number of immune response marker-positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ). |
| Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least CD40L and Another Immune Marker | At Day 0 and 21 | Results are presented as the geometric mean number of CD40L-positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ). |
| Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IFN-γ and Another Immune Marker | At Day 0 and 21 | Results are presented as the geometric mean number of IFN-γ -positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α). |
| Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IL-2 and Another Immune Marker | At Day 0 and 21 | Results are presented as the geometric mean number of IFN-γ -positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ). |
| Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least TNF-α and Another Immune Marker | At Day 0 and 21 | Results are presented as the geometric mean number of IFN-γ -positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L) and interferon gamma (IFN-γ). |
| Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least TNF-α and Another Immune Marker | At Day 0 and 21 | Results are presented as the geometric mean number of IFN-γ -positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L) and interferon gamma (IFN-γ). |
| Number of Subjects Reporting Any and Related Medically Significant Conditions (MSCs) | During the vaccination phase of the study (Day 0 to Day 20) and during the long term follow-up phase of the study (Day 21 to Day 179) | Medically significant conditions assessed include conditions prompting emergency room visits, hospitalizations or physician visits. |
| Serum Hemagglutination-inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains | At Days 0 and 21 | Titers were expressed as Geometric Mean Titers. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. |
| Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains | At Day 21 | A seroconverted subject was defined as a subject who had either a pre-vaccination titer below1:10 and a post-vaccination titer greater than or equal to1:40 or a pre-vaccination titer greater than or equal to1:10 and at least a four-fold increase in post-vaccination titer. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. |
| Seroconversion Factors for HI Antibodies Against Each of the Three Vaccine Strains | At Day 21 | Seroconversion factor was defined as the fold increase in serum HI Geometric Mean Titers post-vaccination compared to Day 0. |
Countries
Belgium, Germany, Norway, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FluAS25 Group Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in the current study. | 475 |
| Fluarix ≥ 65 Years Age Group Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study. | 488 |
| Fluarix 18-40 Years Age Group Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study. | 289 |
| Total | 1,252 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | FluAS25 Group | Fluarix ≥ 65 Years Age Group | Fluarix 18-40 Years Age Group | Total |
|---|---|---|---|---|
| Age, Continuous | 73.8 Years STANDARD_DEVIATION 5.5 | 73.7 Years STANDARD_DEVIATION 5.8 | 30.9 Years STANDARD_DEVIATION 6.64 | 63.86 Years STANDARD_DEVIATION 19 |
| Sex: Female, Male Female | 248 Participants | 253 Participants | 167 Participants | 668 Participants |
| Sex: Female, Male Male | 227 Participants | 235 Participants | 122 Participants | 584 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 346 / 475 | 162 / 488 | 200 / 289 |
| serious Total, serious adverse events | 23 / 475 | 27 / 488 | 4 / 289 |
Outcome results
Primary
Duration of Solicited General Adverse Events
Duration was expressed as the median number of days the symptom was experienced.
Time frame: During a 7-day follow-up period after vaccination
Population: The analysis was performed on the Total Vaccinated Cohort, on subjects that experienced the specific symptom.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FluAS25 Group | Duration of Solicited General Adverse Events | Fever (N= 17; 0; 1) | 1.0 Days |
| FluAS25 Group | Duration of Solicited General Adverse Events | Nausea (N= 35; 23; 17) | 1.0 Days |
| FluAS25 Group | Duration of Solicited General Adverse Events | Myalgia (N= 132; 51; 70) | 2.0 Days |
| FluAS25 Group | Duration of Solicited General Adverse Events | Fatigue (N= 131; 46; 71) | 2.0 Days |
| FluAS25 Group | Duration of Solicited General Adverse Events | Arthralgia (N= 80; 34; 23) | 2.0 Days |
| FluAS25 Group | Duration of Solicited General Adverse Events | Shivering (N= 95; 31; 31) | 1.0 Days |
| FluAS25 Group | Duration of Solicited General Adverse Events | Headache (N= 102; 49; 54) | 1.0 Days |
| Fluarix ≥ 65 Years Age Group | Duration of Solicited General Adverse Events | Arthralgia (N= 80; 34; 23) | 3.0 Days |
| Fluarix ≥ 65 Years Age Group | Duration of Solicited General Adverse Events | Fatigue (N= 131; 46; 71) | 2.0 Days |
| Fluarix ≥ 65 Years Age Group | Duration of Solicited General Adverse Events | Headache (N= 102; 49; 54) | 1.0 Days |
| Fluarix ≥ 65 Years Age Group | Duration of Solicited General Adverse Events | Myalgia (N= 132; 51; 70) | 2.0 Days |
| Fluarix ≥ 65 Years Age Group | Duration of Solicited General Adverse Events | Nausea (N= 35; 23; 17) | 1.0 Days |
| Fluarix ≥ 65 Years Age Group | Duration of Solicited General Adverse Events | Shivering (N= 95; 31; 31) | 2.0 Days |
| Fluarix ≥ 65 Years Age Group | Duration of Solicited General Adverse Events | Fever (N= 17; 0; 1) | NA Days |
| Fluarix 18-40 Years Age Group | Duration of Solicited General Adverse Events | Nausea (N= 35; 23; 17) | 2.0 Days |
| Fluarix 18-40 Years Age Group | Duration of Solicited General Adverse Events | Fatigue (N= 131; 46; 71) | 2.0 Days |
| Fluarix 18-40 Years Age Group | Duration of Solicited General Adverse Events | Fever (N= 17; 0; 1) | 1.0 Days |
| Fluarix 18-40 Years Age Group | Duration of Solicited General Adverse Events | Shivering (N= 95; 31; 31) | 1.0 Days |
| Fluarix 18-40 Years Age Group | Duration of Solicited General Adverse Events | Myalgia (N= 132; 51; 70) | 2.0 Days |
| Fluarix 18-40 Years Age Group | Duration of Solicited General Adverse Events | Headache (N= 102; 49; 54) | 2.0 Days |
| Fluarix 18-40 Years Age Group | Duration of Solicited General Adverse Events | Arthralgia (N= 80; 34; 23) | 2.0 Days |
Primary
Duration of Solicited Local Adverse Events
Duration was expressed as the median number of days the symptom was experienced.
Time frame: During a 7-day follow-up period after vaccination
Population: The analysis was performed on the Total Vaccinated Cohort, on subjects that reported the specific symptom.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FluAS25 Group | Duration of Solicited Local Adverse Events | Ecchymosis (N= 7; 7; 2) | 3.0 Days |
| FluAS25 Group | Duration of Solicited Local Adverse Events | Pain (N= 271; 76; 170) | 2.0 Days |
| FluAS25 Group | Duration of Solicited Local Adverse Events | Redness (N= 111; 14; 16) | 3.0 Days |
| FluAS25 Group | Duration of Solicited Local Adverse Events | Swelling (N= 44; 8; 5) | 3.0 Days |
| Fluarix ≥ 65 Years Age Group | Duration of Solicited Local Adverse Events | Swelling (N= 44; 8; 5) | 1.0 Days |
| Fluarix ≥ 65 Years Age Group | Duration of Solicited Local Adverse Events | Ecchymosis (N= 7; 7; 2) | 2.0 Days |
| Fluarix ≥ 65 Years Age Group | Duration of Solicited Local Adverse Events | Redness (N= 111; 14; 16) | 2.0 Days |
| Fluarix ≥ 65 Years Age Group | Duration of Solicited Local Adverse Events | Pain (N= 271; 76; 170) | 2.0 Days |
| Fluarix 18-40 Years Age Group | Duration of Solicited Local Adverse Events | Swelling (N= 44; 8; 5) | 2.0 Days |
| Fluarix 18-40 Years Age Group | Duration of Solicited Local Adverse Events | Pain (N= 271; 76; 170) | 2.0 Days |
| Fluarix 18-40 Years Age Group | Duration of Solicited Local Adverse Events | Redness (N= 111; 14; 16) | 1.5 Days |
| Fluarix 18-40 Years Age Group | Duration of Solicited Local Adverse Events | Ecchymosis (N= 7; 7; 2) | 4.5 Days |
Primary
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Solicited local AEs assessed include ecchymosis, pain, redness and swelling. Any: any symptom regardless of intensity grade. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter.
Time frame: During a 7-day follow-up period after vaccination
Population: The analysis was performed on the Total Vaccinated Cohort on subjects who completed the symptom sheet.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluAS25 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 Ecchymosis | 0 Subjects |
| FluAS25 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any Swelling | 44 Subjects |
| FluAS25 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any Ecchymosis | 7 Subjects |
| FluAS25 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any Pain | 271 Subjects |
| FluAS25 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 Pain | 2 Subjects |
| FluAS25 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 Swelling | 1 Subjects |
| FluAS25 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any Redness | 111 Subjects |
| FluAS25 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 Redness | 12 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any Pain | 76 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 Pain | 0 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any Ecchymosis | 7 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 Ecchymosis | 0 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any Redness | 14 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 Redness | 0 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any Swelling | 8 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 Swelling | 0 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 Pain | 0 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 Redness | 0 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any Pain | 170 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 Swelling | 0 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 Ecchymosis | 0 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any Swelling | 7 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any Redness | 16 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any Ecchymosis | 2 Subjects |
Primary
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs)
Solicited general AEs assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C). Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 40°C. Related: symptom assessed by the investigator as causally related to the study vaccination.
Time frame: During a 7-day follow-up period after vaccination
Population: The analysis was performed on the Total Vaccinated Cohort on subjects who completed the symptom sheet.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluAS25 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Grade 3 Nausea | 2 Subjects |
| FluAS25 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Grade 3 Headache | 4 Subjects |
| FluAS25 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Grade 3 Fever | 0 Subjects |
| FluAS25 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Any Nausea | 35 Subjects |
| FluAS25 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Related Headache | 87 Subjects |
| FluAS25 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Related Shivering | 88 Subjects |
| FluAS25 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Related Myalgia | 116 Subjects |
| FluAS25 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Any Myalgia | 132 Subjects |
| FluAS25 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Related Arthralgia | 65 Subjects |
| FluAS25 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Grade 3 Myalgia | 4 Subjects |
| FluAS25 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Any Fatigue | 131 Subjects |
| FluAS25 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Any Arthralgia | 80 Subjects |
| FluAS25 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Grade 3 Shivering | 5 Subjects |
| FluAS25 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Grade 3 Fatigue | 4 Subjects |
| FluAS25 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Related Fever | 15 Subjects |
| FluAS25 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Any Shivering | 95 Subjects |
| FluAS25 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Related Fatigue | 109 Subjects |
| FluAS25 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Any Fever | 17 Subjects |
| FluAS25 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Related Nausea | 29 Subjects |
| FluAS25 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Any Headache | 102 Subjects |
| FluAS25 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Grade 3 Arthralgia | 2 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Grade 3 Fatigue | 0 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Any Arthralgia | 34 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Grade 3 Arthralgia | 0 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Any Fatigue | 46 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Related Arthralgia | 20 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Related Fatigue | 29 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Any Headache | 49 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Grade 3 Headache | 1 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Related Headache | 37 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Any Myalgia | 51 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Grade 3 Myalgia | 0 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Related Myalgia | 38 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Any Nausea | 23 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Grade 3 Nausea | 0 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Related Nausea | 15 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Any Shivering | 31 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Grade 3 Shivering | 0 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Related Shivering | 24 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Any Fever | 0 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Grade 3 Fever | 0 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Related Fever | 0 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Related Fatigue | 54 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Any Fever | 1 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Related Nausea | 13 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Grade 3 Fatigue | 1 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Any Myalgia | 70 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Any Shivering | 31 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Any Fatigue | 71 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Related Fever | 1 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Grade 3 Shivering | 0 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Grade 3 Arthralgia | 1 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Grade 3 Fever | 0 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Grade 3 Myalgia | 1 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Related Headache | 39 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Related Shivering | 28 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Related Myalgia | 64 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Grade 3 Headache | 1 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Any Arthralgia | 23 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Any Nausea | 17 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Any Headache | 54 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Related Arthralgia | 22 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Grade 3 Nausea | 0 Subjects |
Primary
Number of Subjects Reporting 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 AE regardless of intensity or relationship to vaccination. Grade 3: AE that prevented normal activity. Related: AE considered by the investigator to be causally related to the study vaccination.
Time frame: During a 21-day follow-up period after vaccination
Population: The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluAS25 Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AEs | 7 Subjects |
| FluAS25 Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AEs | 82 Subjects |
| FluAS25 Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AEs | 19 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AEs | 5 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AEs | 68 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AEs | 6 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AEs | 62 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AEs | 11 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AEs | 5 Subjects |
Secondary
Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least CD40L and Another Immune Marker
Results are presented as the geometric mean number of CD40L-positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).
Time frame: At Day 0 and 21
Population: The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD4 result was available 21 days after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| FluAS25 Group | Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least CD40L and Another Immune Marker | Day 0 (N= 62; 60; 39) | 822.37 Cells per million | Standard Deviation 875.39 |
| FluAS25 Group | Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least CD40L and Another Immune Marker | Day 21 (N= 65; 63; 40) | 1961.18 Cells per million | Standard Deviation 1337.11 |
| Fluarix ≥ 65 Years Age Group | Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least CD40L and Another Immune Marker | Day 0 (N= 62; 60; 39) | 660.01 Cells per million | Standard Deviation 560.95 |
| Fluarix ≥ 65 Years Age Group | Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least CD40L and Another Immune Marker | Day 21 (N= 65; 63; 40) | 981.82 Cells per million | Standard Deviation 1056.18 |
| Fluarix 18-40 Years Age Group | Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least CD40L and Another Immune Marker | Day 0 (N= 62; 60; 39) | 1260.65 Cells per million | Standard Deviation 681.46 |
| Fluarix 18-40 Years Age Group | Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least CD40L and Another Immune Marker | Day 21 (N= 65; 63; 40) | 1556.00 Cells per million | Standard Deviation 830.54 |
Secondary
Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IFN-γ and Another Immune Marker
Results are presented as the geometric mean number of IFN-γ -positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α).
Time frame: At Day 0 and 21
Population: The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD4 result was available 21 days after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| FluAS25 Group | Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IFN-γ and Another Immune Marker | Day 0 (N= 62; 60; 39) | 513.25 Cells per million | Standard Deviation 586.78 |
| FluAS25 Group | Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IFN-γ and Another Immune Marker | Day 21 (N= 65; 63; 40) | 1081.11 Cells per million | Standard Deviation 966.36 |
| Fluarix ≥ 65 Years Age Group | Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IFN-γ and Another Immune Marker | Day 0 (N= 62; 60; 39) | 371.64 Cells per million | Standard Deviation 397.45 |
| Fluarix ≥ 65 Years Age Group | Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IFN-γ and Another Immune Marker | Day 21 (N= 65; 63; 40) | 574.28 Cells per million | Standard Deviation 685.03 |
| Fluarix 18-40 Years Age Group | Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IFN-γ and Another Immune Marker | Day 0 (N= 62; 60; 39) | 753.45 Cells per million | Standard Deviation 556.25 |
| Fluarix 18-40 Years Age Group | Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IFN-γ and Another Immune Marker | Day 21 (N= 65; 63; 40) | 870.84 Cells per million | Standard Deviation 589.37 |
Secondary
Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IL-2 and Another Immune Marker
Results are presented as the geometric mean number of IFN-γ -positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).
Time frame: At Day 0 and 21
Population: The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD4 result was available 21 days after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| FluAS25 Group | Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IL-2 and Another Immune Marker | Day 0 (N= 62; 60; 39) | 769.96 Cells per million | Standard Deviation 809.58 |
| FluAS25 Group | Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IL-2 and Another Immune Marker | Day 21 (N= 65; 63; 40) | 1644.34 Cells per million | Standard Deviation 1110.14 |
| Fluarix ≥ 65 Years Age Group | Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IL-2 and Another Immune Marker | Day 0 (N= 62; 60; 39) | 634.57 Cells per million | Standard Deviation 518.17 |
| Fluarix ≥ 65 Years Age Group | Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IL-2 and Another Immune Marker | Day 21 (N= 65; 63; 40) | 856.60 Cells per million | Standard Deviation 855.82 |
| Fluarix 18-40 Years Age Group | Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IL-2 and Another Immune Marker | Day 0 (N= 62; 60; 39) | 1030.23 Cells per million | Standard Deviation 585.91 |
| Fluarix 18-40 Years Age Group | Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IL-2 and Another Immune Marker | Day 21 (N= 65; 63; 40) | 1288.54 Cells per million | Standard Deviation 664.82 |
Secondary
Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least TNF-α and Another Immune Marker
Results are presented as the geometric mean number of IFN-γ -positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L) and interferon gamma (IFN-γ).
Time frame: At Day 0 and 21
Population: The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD4 result was available 21 days after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| FluAS25 Group | Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least TNF-α and Another Immune Marker | Day 0 (N= 62; 60; 39) | 586.39 Cells per million | Standard Deviation 698.83 |
| FluAS25 Group | Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least TNF-α and Another Immune Marker | Day 21 (N= 65; 63; 40) | 1189.34 Cells per million | Standard Deviation 945.05 |
| Fluarix ≥ 65 Years Age Group | Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least TNF-α and Another Immune Marker | Day 21 (N= 65; 63; 40) | 608.51 Cells per million | Standard Deviation 700.32 |
| Fluarix ≥ 65 Years Age Group | Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least TNF-α and Another Immune Marker | Day 0 (N= 62; 60; 39) | 409.05 Cells per million | Standard Deviation 415.62 |
| Fluarix 18-40 Years Age Group | Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least TNF-α and Another Immune Marker | Day 21 (N= 65; 63; 40) | 921.15 Cells per million | Standard Deviation 549.61 |
| Fluarix 18-40 Years Age Group | Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least TNF-α and Another Immune Marker | Day 0 (N= 62; 60; 39) | 746.02 Cells per million | Standard Deviation 551.82 |
Secondary
Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least CD40L and Another Immune Marker
Results are presented as the geometric mean number of CD40L-positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).
Time frame: At Day 0 and 21
Population: The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD8 result was available 21 days after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| FluAS25 Group | Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least CD40L and Another Immune Marker | Day 0 (N= 55; 54; 39) | 6.19 Cells per million | Standard Deviation 120.88 |
| FluAS25 Group | Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least CD40L and Another Immune Marker | Day 21 (N= 64; 62; 40) | 8.09 Cells per million | Standard Deviation 123.89 |
| Fluarix ≥ 65 Years Age Group | Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least CD40L and Another Immune Marker | Day 0 (N= 55; 54; 39) | 4.33 Cells per million | Standard Deviation 134.18 |
| Fluarix ≥ 65 Years Age Group | Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least CD40L and Another Immune Marker | Day 21 (N= 64; 62; 40) | 5.79 Cells per million | Standard Deviation 85.2 |
| Fluarix 18-40 Years Age Group | Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least CD40L and Another Immune Marker | Day 0 (N= 55; 54; 39) | 2.12 Cells per million | Standard Deviation 220.32 |
| Fluarix 18-40 Years Age Group | Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least CD40L and Another Immune Marker | Day 21 (N= 64; 62; 40) | 3.64 Cells per million | Standard Deviation 71.55 |
Secondary
Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IFN-γ and Another Immune Marker
Results are presented as the geometric mean number of IFN-γ -positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α).
Time frame: At Day 0 and 21
Population: The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD8 result was available 21 days after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| FluAS25 Group | Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IFN-γ and Another Immune Marker | Day 0 (N= 55; 54; 39) | 2.77 Cells per million | Standard Deviation 69.92 |
| FluAS25 Group | Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IFN-γ and Another Immune Marker | Day 21 (N= 64; 62; 40) | 3.09 Cells per million | Standard Deviation 97.36 |
| Fluarix ≥ 65 Years Age Group | Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IFN-γ and Another Immune Marker | Day 0 (N= 55; 54; 39) | 2.64 Cells per million | Standard Deviation 50.62 |
| Fluarix ≥ 65 Years Age Group | Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IFN-γ and Another Immune Marker | Day 21 (N= 64; 62; 40) | 2.82 Cells per million | Standard Deviation 56.06 |
| Fluarix 18-40 Years Age Group | Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IFN-γ and Another Immune Marker | Day 0 (N= 55; 54; 39) | 1.58 Cells per million | Standard Deviation 32.08 |
| Fluarix 18-40 Years Age Group | Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IFN-γ and Another Immune Marker | Day 21 (N= 64; 62; 40) | 2.17 Cells per million | Standard Deviation 28.97 |
Secondary
Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IL-2 and Another Immune Marker
Results are presented as the geometric mean number of IFN-γ -positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).
Time frame: At Day 0 and 21
Population: The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD8 result was available 21 days after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| FluAS25 Group | Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IL-2 and Another Immune Marker | Day 0 (N= 55; 54; 39) | 6.82 Cells per million | Standard Deviation 135.79 |
| FluAS25 Group | Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IL-2 and Another Immune Marker | Day 21 (N= 64; 62; 40) | 12.70 Cells per million | Standard Deviation 159.08 |
| Fluarix ≥ 65 Years Age Group | Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IL-2 and Another Immune Marker | Day 0 (N= 55; 54; 39) | 8.43 Cells per million | Standard Deviation 119.7 |
| Fluarix ≥ 65 Years Age Group | Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IL-2 and Another Immune Marker | Day 21 (N= 64; 62; 40) | 5.64 Cells per million | Standard Deviation 101.15 |
| Fluarix 18-40 Years Age Group | Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IL-2 and Another Immune Marker | Day 0 (N= 55; 54; 39) | 3.21 Cells per million | Standard Deviation 249.46 |
| Fluarix 18-40 Years Age Group | Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IL-2 and Another Immune Marker | Day 21 (N= 64; 62; 40) | 3.20 Cells per million | Standard Deviation 55.75 |
Secondary
Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least TNF-α and Another Immune Marker
Results are presented as the geometric mean number of IFN-γ -positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L) and interferon gamma (IFN-γ).
Time frame: At Day 0 and 21
Population: The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD8 result was available 21 days after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| FluAS25 Group | Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least TNF-α and Another Immune Marker | Day 0 (N= 55; 54; 39) | 3.05 Cells per million | Standard Deviation 72.38 |
| FluAS25 Group | Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least TNF-α and Another Immune Marker | Day 21 (N= 64; 62; 40) | 5.67 Cells per million | Standard Deviation 89.23 |
| Fluarix ≥ 65 Years Age Group | Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least TNF-α and Another Immune Marker | Day 0 (N= 55; 54; 39) | 2.48 Cells per million | Standard Deviation 42.55 |
| Fluarix ≥ 65 Years Age Group | Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least TNF-α and Another Immune Marker | Day 21 (N= 64; 62; 40) | 3.54 Cells per million | Standard Deviation 69.71 |
| Fluarix 18-40 Years Age Group | Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least TNF-α and Another Immune Marker | Day 0 (N= 55; 54; 39) | 3.13 Cells per million | Standard Deviation 44.03 |
| Fluarix 18-40 Years Age Group | Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least TNF-α and Another Immune Marker | Day 21 (N= 64; 62; 40) | 2.73 Cells per million | Standard Deviation 40.3 |
Secondary
Number of Cluster of Differentiation 4 (CD4) T-cells (Per Million CD4 T-cells) Producing at Least 2 Different Immune Markers
Results are presented as the geometric mean number of immune response marker-positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).
Time frame: At Day 0 and 21
Population: The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD4 result was available 21 days after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| FluAS25 Group | Number of Cluster of Differentiation 4 (CD4) T-cells (Per Million CD4 T-cells) Producing at Least 2 Different Immune Markers | Day 0 (N= 62; 60; 39) | 830.72 Cells per million | Standard Deviation 889.9 |
| FluAS25 Group | Number of Cluster of Differentiation 4 (CD4) T-cells (Per Million CD4 T-cells) Producing at Least 2 Different Immune Markers | Day 21 (N= 65; 63; 40) | 2013.28 Cells per million | Standard Deviation 1388.55 |
| Fluarix ≥ 65 Years Age Group | Number of Cluster of Differentiation 4 (CD4) T-cells (Per Million CD4 T-cells) Producing at Least 2 Different Immune Markers | Day 21 (N= 65; 63; 40) | 1010.22 Cells per million | Standard Deviation 1069.96 |
| Fluarix ≥ 65 Years Age Group | Number of Cluster of Differentiation 4 (CD4) T-cells (Per Million CD4 T-cells) Producing at Least 2 Different Immune Markers | Day 0 (N= 62; 60; 39) | 674.91 Cells per million | Standard Deviation 567.07 |
| Fluarix 18-40 Years Age Group | Number of Cluster of Differentiation 4 (CD4) T-cells (Per Million CD4 T-cells) Producing at Least 2 Different Immune Markers | Day 0 (N= 62; 60; 39) | 1276.25 Cells per million | Standard Deviation 701.42 |
| Fluarix 18-40 Years Age Group | Number of Cluster of Differentiation 4 (CD4) T-cells (Per Million CD4 T-cells) Producing at Least 2 Different Immune Markers | Day 21 (N= 65; 63; 40) | 1607.66 Cells per million | Standard Deviation 839.45 |
Secondary
Number of Cluster of Differentiation 8 (CD8) T-cells (Per Million CD8 T-cells) Expressing at Least 2 Different Immune Markers
Results are presented as the geometric mean number of immune response marker-positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).
Time frame: At Day 0 and 21
Population: The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD8 result was available 21 days after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| FluAS25 Group | Number of Cluster of Differentiation 8 (CD8) T-cells (Per Million CD8 T-cells) Expressing at Least 2 Different Immune Markers | Day 0 (N= 55; 54; 39) | 8.25 Cells per million | Standard Deviation 166.35 |
| FluAS25 Group | Number of Cluster of Differentiation 8 (CD8) T-cells (Per Million CD8 T-cells) Expressing at Least 2 Different Immune Markers | Day 21 (N= 64; 62; 40) | 16.75 Cells per million | Standard Deviation 168.54 |
| Fluarix ≥ 65 Years Age Group | Number of Cluster of Differentiation 8 (CD8) T-cells (Per Million CD8 T-cells) Expressing at Least 2 Different Immune Markers | Day 0 (N= 55; 54; 39) | 6.82 Cells per million | Standard Deviation 123.1 |
| Fluarix ≥ 65 Years Age Group | Number of Cluster of Differentiation 8 (CD8) T-cells (Per Million CD8 T-cells) Expressing at Least 2 Different Immune Markers | Day 21 (N= 64; 62; 40) | 6.51 Cells per million | Standard Deviation 112.42 |
| Fluarix 18-40 Years Age Group | Number of Cluster of Differentiation 8 (CD8) T-cells (Per Million CD8 T-cells) Expressing at Least 2 Different Immune Markers | Day 0 (N= 55; 54; 39) | 3.56 Cells per million | Standard Deviation 247.08 |
| Fluarix 18-40 Years Age Group | Number of Cluster of Differentiation 8 (CD8) T-cells (Per Million CD8 T-cells) Expressing at Least 2 Different Immune Markers | Day 21 (N= 64; 62; 40) | 3.48 Cells per million | Standard Deviation 79.78 |
Secondary
Number of Subjects Reporting Any and Related Medically Significant Conditions (MSCs)
Medically significant conditions assessed include conditions prompting emergency room visits, hospitalizations or physician visits.
Time frame: During the vaccination phase of the study (Day 0 to Day 20) and during the long term follow-up phase of the study (Day 21 to Day 179)
Population: The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluAS25 Group | Number of Subjects Reporting Any and Related Medically Significant Conditions (MSCs) | Any MSCs - Vaccination Phase | 22 Subjects |
| FluAS25 Group | Number of Subjects Reporting Any and Related Medically Significant Conditions (MSCs) | Grade 3 MSCs - Vaccination Phase | 3 Subjects |
| FluAS25 Group | Number of Subjects Reporting Any and Related Medically Significant Conditions (MSCs) | Related MSCs - Vaccination Phase | 1 Subjects |
| FluAS25 Group | Number of Subjects Reporting Any and Related Medically Significant Conditions (MSCs) | Any MSCs - Long Term Follow-up Phase | 112 Subjects |
| FluAS25 Group | Number of Subjects Reporting Any and Related Medically Significant Conditions (MSCs) | Grade 3 MSCs - Long Term Follow-up Phase | 23 Subjects |
| FluAS25 Group | Number of Subjects Reporting Any and Related Medically Significant Conditions (MSCs) | Related MSCs - Long Term Follow-up Phase | 0 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Reporting Any and Related Medically Significant Conditions (MSCs) | Related MSCs - Long Term Follow-up Phase | 0 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Reporting Any and Related Medically Significant Conditions (MSCs) | Any MSCs - Vaccination Phase | 25 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Reporting Any and Related Medically Significant Conditions (MSCs) | Any MSCs - Long Term Follow-up Phase | 137 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Reporting Any and Related Medically Significant Conditions (MSCs) | Grade 3 MSCs - Long Term Follow-up Phase | 29 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Reporting Any and Related Medically Significant Conditions (MSCs) | Grade 3 MSCs - Vaccination Phase | 3 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Reporting Any and Related Medically Significant Conditions (MSCs) | Related MSCs - Vaccination Phase | 1 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Reporting Any and Related Medically Significant Conditions (MSCs) | Grade 3 MSCs - Vaccination Phase | 2 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Reporting Any and Related Medically Significant Conditions (MSCs) | Related MSCs - Vaccination Phase | 1 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Reporting Any and Related Medically Significant Conditions (MSCs) | Related MSCs - Long Term Follow-up Phase | 1 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Reporting Any and Related Medically Significant Conditions (MSCs) | Any MSCs - Long Term Follow-up Phase | 71 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Reporting Any and Related Medically Significant Conditions (MSCs) | Any MSCs - Vaccination Phase | 11 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Reporting Any and Related Medically Significant Conditions (MSCs) | Grade 3 MSCs - Long Term Follow-up Phase | 20 Subjects |
Secondary
Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains
A seroconverted subject was defined as a subject who had either a pre-vaccination titer below1:10 and a post-vaccination titer greater than or equal to1:40 or a pre-vaccination titer greater than or equal to1:10 and at least a four-fold increase in post-vaccination titer. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Time frame: At Day 21
Population: The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity haemagglutination-inhibition (HI) which included all evaluable subjects who complied with the protocol up to the end of the active phase, for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluAS25 Group | Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains | A/Wisconsin | 226 Subjects |
| FluAS25 Group | Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains | A/Solomon Islands | 320 Subjects |
| FluAS25 Group | Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains | B/Malaysia | 82 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains | A/Wisconsin | 156 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains | A/Solomon Islands | 238 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains | B/Malaysia | 66 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains | A/Solomon Islands | 94 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains | B/Malaysia | 46 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains | A/Wisconsin | 66 Subjects |
Secondary
Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to1:40 that is usually accepted as indicating protection. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Time frame: At Days 0 and 21
Population: The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity haemagglutination-inhibition (HI) which included all evaluable subjects who complied with the protocol up to the end of the active phase, for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluAS25 Group | Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains | B/Malaysia [Day 21] (N= 447; 461; 271) | 445 Subjects |
| FluAS25 Group | Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains | A/Solomon Islands [Day 0] (N= 445; 461; 270) | 71 Subjects |
| FluAS25 Group | Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains | A/Wisconsin [Day 0] (N= 445; 461; 270) | 381 Subjects |
| FluAS25 Group | Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains | A/Wisconsin [Day 21] (N= 447; 461; 271) | 445 Subjects |
| FluAS25 Group | Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains | A/Solomon Islands [Day 21] (N= 447; 461; 271) | 381 Subjects |
| FluAS25 Group | Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains | B/Malaysia [Day 0] (N= 445; 461; 270) | 392 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains | A/Solomon Islands [Day 0] (N= 445; 461; 270) | 73 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains | B/Malaysia [Day 0] (N= 445; 461; 270) | 399 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains | B/Malaysia [Day 21] (N= 447; 461; 271) | 443 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains | A/Solomon Islands [Day 21] (N= 447; 461; 271) | 306 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains | A/Wisconsin [Day 0] (N= 445; 461; 270) | 362 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains | A/Wisconsin [Day 21] (N= 447; 461; 271) | 442 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains | B/Malaysia [Day 21] (N= 447; 461; 271) | 268 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains | A/Solomon Islands [Day 0] (N= 445; 461; 270) | 164 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains | A/Solomon Islands [Day 21] (N= 447; 461; 271) | 255 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains | A/Wisconsin [Day 21] (N= 447; 461; 271) | 270 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains | B/Malaysia [Day 0] (N= 445; 461; 270) | 236 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains | A/Wisconsin [Day 0] (N= 445; 461; 270) | 235 Subjects |
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.
Time frame: During the vaccination phase of the study (Day 0 to Day 20) and during the long term follow-up phase of the study (Day 21 to Day 179)
Population: The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluAS25 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Any SAEs - Long Term Follow-up Phase | 21 Subjects |
| FluAS25 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Any SAEs - Vaccination Phase | 2 Subjects |
| FluAS25 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Related SAEs - Long Term Follow-up Phase | 0 Subjects |
| FluAS25 Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Related SAEs - Vaccination Phase | 1 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Any SAEs - Long Term Follow-up Phase | 24 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Related SAEs - Vaccination Phase | 0 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Any SAEs - Vaccination Phase | 3 Subjects |
| Fluarix ≥ 65 Years Age Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Related SAEs - Long Term Follow-up Phase | 0 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Related SAEs - Vaccination Phase | 0 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Any SAEs - Vaccination Phase | 1 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Related SAEs - Long Term Follow-up Phase | 0 Subjects |
| Fluarix 18-40 Years Age Group | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | Any SAEs - Long Term Follow-up Phase | 3 Subjects |
Secondary
Seroconversion Factors for HI Antibodies Against Each of the Three Vaccine Strains
Seroconversion factor was defined as the fold increase in serum HI Geometric Mean Titers post-vaccination compared to Day 0.
Time frame: At Day 21
Population: The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity haemagglutination-inhibition (HI) which included all evaluable subjects who complied with the protocol up to the end of the active phase, for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| FluAS25 Group | Seroconversion Factors for HI Antibodies Against Each of the Three Vaccine Strains | B/Malaysia | 2.1 Fold increase |
| FluAS25 Group | Seroconversion Factors for HI Antibodies Against Each of the Three Vaccine Strains | A/Wisconsin | 3.9 Fold increase |
| FluAS25 Group | Seroconversion Factors for HI Antibodies Against Each of the Three Vaccine Strains | A/Solomon Islands | 9.8 Fold increase |
| Fluarix ≥ 65 Years Age Group | Seroconversion Factors for HI Antibodies Against Each of the Three Vaccine Strains | B/Malaysia | 1.8 Fold increase |
| Fluarix ≥ 65 Years Age Group | Seroconversion Factors for HI Antibodies Against Each of the Three Vaccine Strains | A/Wisconsin | 2.7 Fold increase |
| Fluarix ≥ 65 Years Age Group | Seroconversion Factors for HI Antibodies Against Each of the Three Vaccine Strains | A/Solomon Islands | 5.0 Fold increase |
| Fluarix 18-40 Years Age Group | Seroconversion Factors for HI Antibodies Against Each of the Three Vaccine Strains | B/Malaysia | 1.9 Fold increase |
| Fluarix 18-40 Years Age Group | Seroconversion Factors for HI Antibodies Against Each of the Three Vaccine Strains | A/Solomon Islands | 2.9 Fold increase |
| Fluarix 18-40 Years Age Group | Seroconversion Factors for HI Antibodies Against Each of the Three Vaccine Strains | A/Wisconsin | 2.2 Fold increase |
Secondary
Serum Hemagglutination-inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains
Titers were expressed as Geometric Mean Titers. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Time frame: At Days 0 and 21
Population: The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity haemagglutination-inhibition (HI) which included all evaluable subjects who complied with the protocol up to the end of the active phase, for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| FluAS25 Group | Serum Hemagglutination-inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains | B/Malaysia [Day 0] (N= 445; 461; 270) | 95.8 Titer |
| FluAS25 Group | Serum Hemagglutination-inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains | A/Wisconsin [Day 0] (N= 445; 461; 270) | 110.0 Titer |
| FluAS25 Group | Serum Hemagglutination-inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains | B/Malaysia [Day 21] (N= 447; 461; 271) | 202.2 Titer |
| FluAS25 Group | Serum Hemagglutination-inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains | A/Wisconsin [Day 21] (N= 447; 461; 271) | 430.6 Titer |
| FluAS25 Group | Serum Hemagglutination-inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains | A/Solomon Islands [Day 21] (N= 447; 461; 271) | 103.5 Titer |
| FluAS25 Group | Serum Hemagglutination-inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains | A/Solomon Islands [Day 0] (N= 445; 461; 270) | 10.5 Titer |
| Fluarix ≥ 65 Years Age Group | Serum Hemagglutination-inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains | A/Solomon Islands [Day 0] (N= 445; 461; 270) | 10.8 Titer |
| Fluarix ≥ 65 Years Age Group | Serum Hemagglutination-inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains | B/Malaysia [Day 21] (N= 447; 461; 271) | 152.3 Titer |
| Fluarix ≥ 65 Years Age Group | Serum Hemagglutination-inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains | A/Solomon Islands [Day 21] (N= 447; 461; 271) | 53.7 Titer |
| Fluarix ≥ 65 Years Age Group | Serum Hemagglutination-inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains | A/Wisconsin [Day 0] (N= 445; 461; 270) | 79.5 Titer |
| Fluarix ≥ 65 Years Age Group | Serum Hemagglutination-inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains | A/Wisconsin [Day 21] (N= 447; 461; 271) | 217.9 Titer |
| Fluarix ≥ 65 Years Age Group | Serum Hemagglutination-inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains | B/Malaysia [Day 0] (N= 445; 461; 270) | 82.5 Titer |
| Fluarix 18-40 Years Age Group | Serum Hemagglutination-inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains | A/Wisconsin [Day 21] (N= 447; 461; 271) | 251.2 Titer |
| Fluarix 18-40 Years Age Group | Serum Hemagglutination-inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains | A/Solomon Islands [Day 21] (N= 447; 461; 271) | 143.4 Titer |
| Fluarix 18-40 Years Age Group | Serum Hemagglutination-inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains | A/Solomon Islands [Day 0] (N= 445; 461; 270) | 48.9 Titer |
| Fluarix 18-40 Years Age Group | Serum Hemagglutination-inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains | B/Malaysia [Day 0] (N= 445; 461; 270) | 110.5 Titer |
| Fluarix 18-40 Years Age Group | Serum Hemagglutination-inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains | A/Wisconsin [Day 0] (N= 445; 461; 270) | 112.5 Titer |
| Fluarix 18-40 Years Age Group | Serum Hemagglutination-inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains | B/Malaysia [Day 21] (N= 447; 461; 271) | 209.2 Titer |