Influenza
Conditions
Keywords
GSK Bio's influenza vaccine GSK576389A, Influenza Infection, Fluarix
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 study, the subjects previously enrolled in study 107973 will receive a dose with the 2007-2008 season's formulations of Fluarix or GSK576389A. Only subjects who were previously enrolled in study 107973 (NCT00386113) are eligible for participation in this study.
Detailed description
This study is a year 3 revaccination study. Second year revaccination was done in study 107973 (NCT00386113). First year revaccination was done in study 104540 (NCT00318058). Primary study was study 103304. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007
Interventions
BIOLOGICALGSK Biologicals' influenza vaccine GSK576389A
Single dose, intramuscular injection
BIOLOGICALFluarix™
Single dose, intramuscular injection
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
67 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects who were previously vaccinated with GlaxoSmithKline Biologicals Fluarix™ or GSK576389A vaccines in the 107973 study (NCT00386113). * Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. * A male or female aged \>= 67 years at the time of re-vaccination. * Written informed consent obtained from the subject. * Free of an acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed examination) before entering into the study.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days prior to vaccination, or planned use during the study period. * 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 21 days after vaccination. * Confirmed influenza infection since the date of previous vaccination. * Planned administration of an influenza vaccine other than the study vaccines during the entire study period. * Vaccination against influenza since January 2007 with the Northern Hemisphere 2007/2008 influenza vaccine or 2006/2007 influenza vaccine. * Administration of more than 14 days of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine. * 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 clinical evaluation (medical history and medical history directed 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 administration of the study vaccine or planned administration during the study. * Any medical conditions in which intramuscular injections are contraindicated.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Throughout the entire study (up to Day 21) | 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. Any: occurrence of any SAE regardless of their relationship to vaccination. Related: SAE assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | During a 7-day follow-up period after vaccination | Solicited local symptoms 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 Symptoms | During a 7-day follow-up period after vaccination | Duration was expressed as median number of days any symptom persisted. Solicited local symptoms assessed include ecchymosis, pain, redness and swelling. Any: occurrence of any local symptom regardless of their intensity grade. |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | During a 7-day follow-up period after vaccination | Solicited general symptoms 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 39°C. Related: symptom assessed by the investigator as causally related to the study vaccination. |
| Duration of Solicited General Symptoms | During a 7-day follow-up period after vaccination | Duration was expressed as median number of days any symptom persisted. Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: occurrence of any general symptom regardless of their intensity grade or relationship to vaccination. |
| 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: occurrence of any unsolicited AE regardless of their intensity grade or relationship to vaccination. Grade 3: unsolicited AE that prevented normal everyday activities. Related: unsolicited AE assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs) | During a 21-day follow-up period after vaccination | Medically Significant Conditions (MSCs) included all unsolicited adverse events that resulted in a medically attended visit. Any: occurrence of any MSC regardless of their intensity grade or relationship to vaccination. Grade 3: MSC that prevented normal everyday activities. Related: MSC assessed by the investigator as causally related to the study vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Haemagglutination 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 Seropositive for HI Antibodies Against Each of the Three Vaccine Strains | At Days 0 and 21 | A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10. 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 (SCFs) for HI Antibodies Against Each of the Three Vaccine Strains | At Day 21 | Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. |
| 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 to 1:40 that usually is accepted as indicating protection. |
| Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | At Days 0 and 21 | Results are presented as geometric mean number of specific influenza CD4 T lymphocytes per million T lymphocytes. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. Results are given for All doubles (i.e. CD4 T lymphocytes expressing at least 2 different cytokines \[Cluster of Differentiation 40L (CD40L), Interleukin-2 (IL-2), Tumor Necrosis Factor alpha (TNF-α), Interferon gamma (IFN-γ)\]) and for CD4 T lymphocytes expressing one particular cytokine (CD40L, IL-2, TNF-α, or IFN-γ) and least one other. |
| Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | At Days 0 and 21 | Results are presented as geometric mean number of specific influenza CD8 T lymphocytes per million T lymphocytes. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. Results are given for All doubles (i.e. CD8 T lymphocytes expressing at least 2 different cytokines \[Cluster of Differentiation 40L (CD40L), Interleukin-2 (IL-2), Tumor Necrosis Factor alpha (TNF-α), Interferon gamma (IFN-γ)\]) and for CD8 T lymphocytes expressing one particular cytokine (CD40L, IL-2, TNF-α, or IFN-γ) and least one other. |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FluAS25 (GSK576389A) Group Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A). | 33 |
| Fluarix Group Subjects received 1 dose of Fluarix™. | 35 |
| Total | 68 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
Baseline characteristics
| Characteristic | FluAS25 (GSK576389A) Group | Fluarix Group | Total |
|---|---|---|---|
| Age, Continuous | 73.1 Years STANDARD_DEVIATION 4.53 | 73.2 Years STANDARD_DEVIATION 5.34 | 73.15 Years STANDARD_DEVIATION 4.93 |
| Sex: Female, Male Female | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Male | 13 Participants | 15 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 24 / 33 | 17 / 35 |
| serious Total, serious adverse events | 0 / 33 | 0 / 35 |
Outcome results
Primary
Duration of Solicited General Symptoms
Duration was expressed as median number of days any symptom persisted. Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: occurrence of any general symptom regardless of their intensity grade or relationship to vaccination.
Time frame: During a 7-day follow-up period after vaccination
Population: The analysis was performed on the Total Vaccinated Cohort on those subjects who reported the specific symptom.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FluAS25 (GSK576389A) Group | Duration of Solicited General Symptoms | Headache (N= 8; 3) | 1.5 Days |
| FluAS25 (GSK576389A) Group | Duration of Solicited General Symptoms | Nausea (N= 3; 1) | 4.0 Days |
| FluAS25 (GSK576389A) Group | Duration of Solicited General Symptoms | Fatigue (N= 8; 3) | 2.5 Days |
| FluAS25 (GSK576389A) Group | Duration of Solicited General Symptoms | Shivering (N= 6; 3) | 1.0 Days |
| FluAS25 (GSK576389A) Group | Duration of Solicited General Symptoms | Myalgia (N= 8; 1) | 2.0 Days |
| FluAS25 (GSK576389A) Group | Duration of Solicited General Symptoms | Fever (N= 1; 0) | NA Days |
| FluAS25 (GSK576389A) Group | Duration of Solicited General Symptoms | Arthralgia (N= 8; 5) | 2.0 Days |
| Fluarix Group | Duration of Solicited General Symptoms | Fever (N= 1; 0) | NA Days |
| Fluarix Group | Duration of Solicited General Symptoms | Arthralgia (N= 8; 5) | 3.0 Days |
| Fluarix Group | Duration of Solicited General Symptoms | Fatigue (N= 8; 3) | 1.0 Days |
| Fluarix Group | Duration of Solicited General Symptoms | Headache (N= 8; 3) | 1.0 Days |
| Fluarix Group | Duration of Solicited General Symptoms | Myalgia (N= 8; 1) | 1.0 Days |
| Fluarix Group | Duration of Solicited General Symptoms | Nausea (N= 3; 1) | 2.0 Days |
| Fluarix Group | Duration of Solicited General Symptoms | Shivering (N= 6; 3) | 1.0 Days |
Primary
Duration of Solicited Local Symptoms
Duration was expressed as median number of days any symptom persisted. Solicited local symptoms assessed include ecchymosis, pain, redness and swelling. Any: occurrence of any local symptom regardless of their intensity grade.
Time frame: During a 7-day follow-up period after vaccination
Population: The analysis was performed on the Total Vaccinated Cohort on those subjects who reported the specific symptom.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FluAS25 (GSK576389A) Group | Duration of Solicited Local Symptoms | Ecchymosis (N= 0; 1) | NA Days |
| FluAS25 (GSK576389A) Group | Duration of Solicited Local Symptoms | Pain (N= 17; 7) | 2.0 Days |
| FluAS25 (GSK576389A) Group | Duration of Solicited Local Symptoms | Redness (N= 10; 4) | 2.5 Days |
| FluAS25 (GSK576389A) Group | Duration of Solicited Local Symptoms | Swelling (N= 2; 2) | 1.5 Days |
| Fluarix Group | Duration of Solicited Local Symptoms | Swelling (N= 2; 2) | 2.5 Days |
| Fluarix Group | Duration of Solicited Local Symptoms | Ecchymosis (N= 0; 1) | 5.0 Days |
| Fluarix Group | Duration of Solicited Local Symptoms | Redness (N= 10; 4) | 2.0 Days |
| Fluarix Group | Duration of Solicited Local Symptoms | Pain (N= 17; 7) | 2.0 Days |
Primary
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Solicited local symptoms 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 including all subjects with the study vaccine administered.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluAS25 (GSK576389A) Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 pain | 0 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any ecchymosis | 0 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 ecchymosis | 0 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any pain | 17 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any redness | 10 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 redness | 1 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any swelling | 2 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 swelling | 0 Subjects |
| Fluarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any pain | 7 Subjects |
| Fluarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 pain | 0 Subjects |
| Fluarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 swelling | 0 Subjects |
| Fluarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 redness | 0 Subjects |
| Fluarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any ecchymosis | 1 Subjects |
| Fluarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any redness | 4 Subjects |
| Fluarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 ecchymosis | 0 Subjects |
| Fluarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any swelling | 2 Subjects |
Primary
Number of Subjects Reporting 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. Any: occurrence of any SAE regardless of their relationship to vaccination. Related: SAE assessed by the investigator as causally related to the study vaccination.
Time frame: Throughout the entire study (up to Day 21)
Population: The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluAS25 (GSK576389A) Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Any SAEs | 0 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Related SAEs | 0 Subjects |
| Fluarix Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Any SAEs | 0 Subjects |
| Fluarix Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Related SAEs | 0 Subjects |
Primary
Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Medically Significant Conditions (MSCs) included all unsolicited adverse events that resulted in a medically attended visit. Any: occurrence of any MSC regardless of their intensity grade or relationship to vaccination. Grade 3: MSC that prevented normal everyday activities. Related: MSC assessed by the investigator as 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 including all subjects with the study vaccine administered.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluAS25 (GSK576389A) Group | Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs) | Any MSCs | 2 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs) | Grade 3 MSCs | 1 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs) | Related MSCs | 0 Subjects |
| Fluarix Group | Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs) | Any MSCs | 4 Subjects |
| Fluarix Group | Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs) | Grade 3 MSCs | 0 Subjects |
| Fluarix Group | Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs) | Related MSCs | 0 Subjects |
Primary
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Solicited general symptoms 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 39°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 including all subjects with the study vaccine administered.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluAS25 (GSK576389A) Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any arthralgia | 8 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 arthralgia | 0 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related arthralgia | 7 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any fatigue | 8 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 fatigue | 0 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related fatigue | 8 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any headache | 8 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 headache | 0 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related headache | 6 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any myalgia | 8 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 myalgia | 0 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related myalgia | 8 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any nausea | 3 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 nausea | 0 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related nausea | 2 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any shivering | 6 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 shivering | 0 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related shivering | 5 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any fever | 1 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 fever | 0 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related fever | 1 Subjects |
| Fluarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 myalgia | 0 Subjects |
| Fluarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any arthralgia | 5 Subjects |
| Fluarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any fever | 0 Subjects |
| Fluarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 arthralgia | 0 Subjects |
| Fluarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related myalgia | 0 Subjects |
| Fluarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related arthralgia | 1 Subjects |
| Fluarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 shivering | 0 Subjects |
| Fluarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any fatigue | 3 Subjects |
| Fluarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any nausea | 1 Subjects |
| Fluarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 fatigue | 0 Subjects |
| Fluarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related fever | 0 Subjects |
| Fluarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related fatigue | 2 Subjects |
| Fluarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 nausea | 0 Subjects |
| Fluarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any headache | 3 Subjects |
| Fluarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related shivering | 2 Subjects |
| Fluarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 headache | 0 Subjects |
| Fluarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related nausea | 0 Subjects |
| Fluarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related headache | 2 Subjects |
| Fluarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 fever | 0 Subjects |
| Fluarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any myalgia | 1 Subjects |
| Fluarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any shivering | 3 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: occurrence of any unsolicited AE regardless of their intensity grade or relationship to vaccination. Grade 3: unsolicited AE that prevented normal everyday activities. Related: unsolicited AE assessed by the investigator as 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 including all subjects with the study vaccine administered.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluAS25 (GSK576389A) Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AEs | 5 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AEs | 1 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AEs | 1 Subjects |
| Fluarix Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AEs | 0 Subjects |
| Fluarix Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AEs | 7 Subjects |
| Fluarix Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AEs | 2 Subjects |
Secondary
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
Results are presented as geometric mean number of specific influenza CD4 T lymphocytes per million T lymphocytes. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. Results are given for All doubles (i.e. CD4 T lymphocytes expressing at least 2 different cytokines \[Cluster of Differentiation 40L (CD40L), Interleukin-2 (IL-2), Tumor Necrosis Factor alpha (TNF-α), Interferon gamma (IFN-γ)\]) and for CD4 T lymphocytes expressing one particular cytokine (CD40L, IL-2, TNF-α, or IFN-γ) and least one other.
Time frame: At Days 0 and 21
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IFN-γ B/Malaysia [Day 0] (N= 30; 32) | 405.44 Cells per million | Standard Deviation 279.02 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IL-2 Pooled Strains [Day 0] (N= 30; 32) | 1192.89 Cells per million | Standard Deviation 595.71 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | CD40L B/Malaysia [Day 0] (N= 30; 32) | 640.49 Cells per million | Standard Deviation 370.62 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IFN-γ B/Malaysia [Day 21] (N= 25; 31) | 442.51 Cells per million | Standard Deviation 384.08 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IFN-γ Pooled Strains [Day 0] (N= 30; 32) | 824.34 Cells per million | Standard Deviation 491.16 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | TNF-α A/Solomon Islands [Day 21] (N= 25; 31) | 371.92 Cells per million | Standard Deviation 409.87 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IFN-γ A/Solomon Islands [Day 0] (N= 30; 32) | 393.40 Cells per million | Standard Deviation 328.18 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | TNF-α A/Wisconsin [Day 0] (N= 30; 32) | 584.58 Cells per million | Standard Deviation 352.86 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IFN-γ Pooled Strains [Day 21] (N= 25; 31) | 840.65 Cells per million | Standard Deviation 671.16 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | CD40L A/Solomon Islands [Day 0] (N= 30; 32) | 606.58 Cells per million | Standard Deviation 484.99 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | All Doubles B/Malaysia [Day 0] (N= 30; 32) | 643.26 Cells per million | Standard Deviation 382.49 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | All Doubles Pooled Strains [Day 0] (N= 30; 32) | 1401.41 Cells per million | Standard Deviation 671.68 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | CD40L A/Wisconsin [Day 0] (N= 30; 32) | 871.43 Cells per million | Standard Deviation 512.44 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | CD40L A/Wisconsin [Day 21] (N= 25; 31) | 829.38 Cells per million | Standard Deviation 648.5 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | CD40L Pooled Strains [Day 0] (N= 30; 32) | 1388.14 Cells per million | Standard Deviation 661.04 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | CD40L Pooled Strains [Day 21] (N= 25; 31) | 1209.75 Cells per million | Standard Deviation 996.45 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IFN-γ A/Wisconsin [Day 0] (N= 30; 32) | 477.81 Cells per million | Standard Deviation 299.82 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IL-2 A/Solomon Islands [Day 0] (N= 30; 32) | 550.06 Cells per million | Standard Deviation 433.42 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IL-2 Pooled Strains [Day 21] (N= 25; 31) | 977.48 Cells per million | Standard Deviation 819.44 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | TNF-α A/Solomon Islands [Day 0] (N= 30; 32) | 270.39 Cells per million | Standard Deviation 328.2 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IFN-γ A/Solomon Islands [Day 21] (N= 25; 31) | 411.23 Cells per million | Standard Deviation 509.98 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | TNF-α Pooled Strains [Day 0] (N= 30; 32) | 794.15 Cells per million | Standard Deviation 504.33 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | TNF-α A/Wisconsin [Day 21] (N= 25; 31) | 432.47 Cells per million | Standard Deviation 428.19 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IL-2 A/Solomon Islands [Day 21] (N= 25; 31) | 635.35 Cells per million | Standard Deviation 631.73 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | TNF-α B/Malaysia [Day 0] (N= 30; 32) | 278.06 Cells per million | Standard Deviation 239.29 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | CD40L B/Malaysia [Day 21] (N= 25; 31) | 648.93 Cells per million | Standard Deviation 535.97 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | TNF-α B/Malaysia [Day 21] (N= 25; 31) | 299.35 Cells per million | Standard Deviation 322.28 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IL-2 A/Wisconsin [Day 0] (N= 30; 32) | 738.42 Cells per million | Standard Deviation 509.02 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | All Doubles Pooled Strains [Day 21] (N= 25; 31) | 1227.87 Cells per million | Standard Deviation 1013.31 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | TNF-α Pooled Strains [Day 21] (N= 25; 31) | 674.35 Cells per million | Standard Deviation 584.5 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IL-2 A/Wisconsin [Day 21] (N= 25; 31) | 682.25 Cells per million | Standard Deviation 547.67 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | All Doubles A/Solomon Islands [Day 0] (N= 30; 32) | 611.15 Cells per million | Standard Deviation 487.68 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IFN-γ A/Wisconsin [Day 21] (N= 25; 31) | 357.56 Cells per million | Standard Deviation 423.9 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | All Doubles A/Solomon Islands [Day 21] (N= 25; 31) | 761.22 Cells per million | Standard Deviation 783.59 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IL-2 B/Malaysia [Day 0] (N= 30; 32) | 562.01 Cells per million | Standard Deviation 340.18 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | All Doubles A/Wisconsin [Day 0] (N= 30; 32) | 877.26 Cells per million | Standard Deviation 529.44 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | All Doubles A/Wisconsin [Day 21] (N= 25; 31) | 830.38 Cells per million | Standard Deviation 652.85 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | CD40L A/Solomon Islands [Day 21] (N= 25; 31) | 758.40 Cells per million | Standard Deviation 773.73 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | All Doubles B/Malaysia [Day 21] (N= 25; 31) | 657.31 Cells per million | Standard Deviation 542.67 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IL-2 B/Malaysia [Day 21] (N= 25; 31) | 577.43 Cells per million | Standard Deviation 470.86 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IL-2 B/Malaysia [Day 21] (N= 25; 31) | 194.20 Cells per million | Standard Deviation 319.95 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | All Doubles Pooled Strains [Day 21] (N= 25; 31) | 545.68 Cells per million | Standard Deviation 480.37 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | CD40L A/Solomon Islands [Day 0] (N= 30; 32) | 341.61 Cells per million | Standard Deviation 291.23 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | CD40L A/Solomon Islands [Day 21] (N= 25; 31) | 279.59 Cells per million | Standard Deviation 284.97 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | CD40L A/Wisconsin [Day 0] (N= 30; 32) | 472.33 Cells per million | Standard Deviation 427.69 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | CD40L A/Wisconsin [Day 21] (N= 25; 31) | 353.78 Cells per million | Standard Deviation 377.73 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | CD40L B/Malaysia [Day 0] (N= 30; 32) | 387.23 Cells per million | Standard Deviation 280.03 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | CD40L B/Malaysia [Day 21] (N= 25; 31) | 188.93 Cells per million | Standard Deviation 361.66 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | CD40L Pooled Strains [Day 0] (N= 30; 32) | 757.53 Cells per million | Standard Deviation 489.79 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | CD40L Pooled Strains [Day 21] (N= 25; 31) | 539.55 Cells per million | Standard Deviation 476.23 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IFN-γ A/Solomon Islands [Day 0] (N= 30; 32) | 180.69 Cells per million | Standard Deviation 182.12 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IFN-γ A/Solomon Islands [Day 21] (N= 25; 31) | 150.29 Cells per million | Standard Deviation 185.78 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IFN-γ A/Wisconsin [Day 0] (N= 30; 32) | 232.70 Cells per million | Standard Deviation 278.1 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IFN-γ A/Wisconsin [Day 21] (N= 25; 31) | 212.25 Cells per million | Standard Deviation 191.16 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IFN-γ B/Malaysia [Day 0] (N= 30; 32) | 175.13 Cells per million | Standard Deviation 210.56 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IFN-γ Pooled Strains [Day 0] (N= 30; 32) | 436.69 Cells per million | Standard Deviation 307.38 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IFN-γ Pooled Strains [Day 21] (N= 25; 31) | 343.86 Cells per million | Standard Deviation 315.56 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IL-2 A/Solomon Islands [Day 0] (N= 30; 32) | 321.49 Cells per million | Standard Deviation 258.81 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IL-2 A/Solomon Islands [Day 21] (N= 25; 31) | 241.86 Cells per million | Standard Deviation 225.01 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IL-2 A/Wisconsin [Day 0] (N= 30; 32) | 407.21 Cells per million | Standard Deviation 381.85 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IL-2 A/Wisconsin [Day 21] (N= 25; 31) | 259.27 Cells per million | Standard Deviation 313.49 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IL-2 B/Malaysia [Day 0] (N= 30; 32) | 377.10 Cells per million | Standard Deviation 257.06 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | All Doubles Pooled Strains [Day 0] (N= 30; 32) | 767.10 Cells per million | Standard Deviation 490.04 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IL-2 Pooled Strains [Day 0] (N= 30; 32) | 720.90 Cells per million | Standard Deviation 421.55 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IL-2 Pooled Strains [Day 21] (N= 25; 31) | 463.25 Cells per million | Standard Deviation 390.68 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | TNF-α A/Solomon Islands [Day 0] (N= 30; 32) | 194.00 Cells per million | Standard Deviation 169.53 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | TNF-α A/Solomon Islands [Day 21] (N= 25; 31) | 129.21 Cells per million | Standard Deviation 163.1 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | All Doubles A/Wisconsin [Day 0] (N= 30; 32) | 476.38 Cells per million | Standard Deviation 438.45 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | All Doubles A/Wisconsin [Day 21] (N= 25; 31) | 357.12 Cells per million | Standard Deviation 376.31 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IFN-γ B/Malaysia [Day 21] (N= 25; 31) | 174.94 Cells per million | Standard Deviation 229.3 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | TNF-α A/Wisconsin [Day 0] (N= 30; 32) | 334.97 Cells per million | Standard Deviation 281.45 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | TNF-α A/Wisconsin [Day 21] (N= 25; 31) | 271.33 Cells per million | Standard Deviation 204.03 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | TNF-α B/Malaysia [Day 0] (N= 30; 32) | 140.68 Cells per million | Standard Deviation 165.67 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | TNF-α B/Malaysia [Day 21] (N= 25; 31) | 102.33 Cells per million | Standard Deviation 205.58 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | TNF-α Pooled Strains [Day 0] (N= 30; 32) | 496.30 Cells per million | Standard Deviation 298.79 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | TNF-α Pooled Strains [Day 21] (N= 25; 31) | 251.59 Cells per million | Standard Deviation 290.29 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | All Doubles A/Solomon Islands [Day 0] (N= 30; 32) | 353.41 Cells per million | Standard Deviation 289.83 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | All Doubles A/Solomon Islands [Day 21] (N= 25; 31) | 285.45 Cells per million | Standard Deviation 288.42 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | All Doubles B/Malaysia [Day 0] (N= 30; 32) | 391.89 Cells per million | Standard Deviation 285.28 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | All Doubles B/Malaysia [Day 21] (N= 25; 31) | 200.13 Cells per million | Standard Deviation 370.22 |
Secondary
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
Results are presented as geometric mean number of specific influenza CD8 T lymphocytes per million T lymphocytes. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. Results are given for All doubles (i.e. CD8 T lymphocytes expressing at least 2 different cytokines \[Cluster of Differentiation 40L (CD40L), Interleukin-2 (IL-2), Tumor Necrosis Factor alpha (TNF-α), Interferon gamma (IFN-γ)\]) and for CD8 T lymphocytes expressing one particular cytokine (CD40L, IL-2, TNF-α, or IFN-γ) and least one other.
Time frame: At Days 0 and 21
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IL-2 B/Malaysia [Day 0] (N= 29; 32) | 4.86 Cells per million | Standard Deviation 77.2 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | All Doubles Pooled Strains [Day 0] (N= 29; 32) | 8.67 Cells per million | Standard Deviation 123.74 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | All Doubles Pooled Strains [Day 21] (N= 24; 31) | 10.96 Cells per million | Standard Deviation 135.32 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | CD40L A/Solomon Islands [Day 0] (N= 30; 32) | 2.05 Cells per million | Standard Deviation 27.92 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | CD40L A/Solomon Islands [Day 21] (N= 25; 31) | 5.00 Cells per million | Standard Deviation 52.91 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | CD40L Pooled Strains [Day 0] (N= 29; 32) | 6.61 Cells per million | Standard Deviation 69.93 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IFN-γ A/Wisconsin [Day 21] (N= 25; 31) | 1.41 Cells per million | Standard Deviation 19.53 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IL-2 Pooled Strains [Day 0] (N= 29; 32) | 7.44 Cells per million | Standard Deviation 95.7 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | TNF-α B/Malaysia [Day 21] (N= 25; 31) | 1.92 Cells per million | Standard Deviation 127.13 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | All Doubles A/Solomon Islands [Day 0] (N= 30; 32) | 2.50 Cells per million | Standard Deviation 54.81 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | All Doubles A/Solomon Islands [Day 21] (N= 25; 31) | 6.18 Cells per million | Standard Deviation 80.49 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | All Doubles A/Wisconsin [Day 0] (N= 29; 32) | 5.48 Cells per million | Standard Deviation 87.38 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | All Doubles A/Wisconsin [Day 21] (N= 25; 31) | 3.11 Cells per million | Standard Deviation 95.32 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | All Doubles B/Malaysia [Day 0] (N= 29; 32) | 6.20 Cells per million | Standard Deviation 90.23 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | All Doubles B/Malaysia [Day 21] (N= 25; 31) | 3.26 Cells per million | Standard Deviation 186.7 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | CD40L A/Wisconsin [Day 0] (N= 29; 32) | 4.28 Cells per million | Standard Deviation 60.42 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | CD40L A/Wisconsin [Day 21] (N= 25; 31) | 2.14 Cells per million | Standard Deviation 51.75 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | CD40L B/Malaysia [Day 0] (N= 29; 32) | 6.59 Cells per million | Standard Deviation 77.3 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | CD40L B/Malaysia [Day 21] (N= 25; 31) | 3.08 Cells per million | Standard Deviation 75.58 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | CD40L Pooled Strains [Day 21] (N= 24; 31) | 6.37 Cells per million | Standard Deviation 88.95 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IFN-γ A/Solomon Islands [Day 0] (N= 30; 32) | 1.77 Cells per million | Standard Deviation 25.17 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IFN-γ A/Solomon Islands [Day 21] (N= 25; 31) | 1.40 Cells per million | Standard Deviation 18 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IFN-γ A/Wisconsin [Day 0] (N= 29; 32) | 1.96 Cells per million | Standard Deviation 58.89 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IFN-γ B/Malaysia [Day 0] (N= 29; 32) | 3.18 Cells per million | Standard Deviation 60.84 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IFN-γ B/Malaysia [Day 21] (N= 25; 31) | 1.92 Cells per million | Standard Deviation 127.13 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IFN-γ Pooled Strains [Day 0] (N= 29; 32) | 2.39 Cells per million | Standard Deviation 93.19 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IFN-γ Pooled Strains [Day 21] (N= 24; 31) | 3.24 Cells per million | Standard Deviation 61.69 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IL-2 A/Solomon Islands [Day 0] (N= 30; 32) | 2.49 Cells per million | Standard Deviation 54.69 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IL-2 A/Solomon Islands [Day 21] (N= 25; 31) | 4.39 Cells per million | Standard Deviation 76.84 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IL-2 A/Wisconsin [Day 0] (N= 29; 32) | 5.27 Cells per million | Standard Deviation 69.84 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IL-2 A/Wisconsin [Day 21] (N= 25; 31) | 2.63 Cells per million | Standard Deviation 95.37 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IL-2 B/Malaysia [Day 21] (N= 25; 31) | 2.60 Cells per million | Standard Deviation 75.43 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IL-2 Pooled Strains [Day 21] (N= 24; 31) | 6.63 Cells per million | Standard Deviation 107.41 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | TNF-α A/Solomon Islands [Day 0] (N= 30; 32) | 1.58 Cells per million | Standard Deviation 23.46 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | TNF-α A/Solomon Islands [Day 21] (N= 25; 31) | 2.47 Cells per million | Standard Deviation 55.2 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | TNF-α A/Wisconsin [Day 0] (N= 29; 32) | 2.36 Cells per million | Standard Deviation 69.91 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | TNF-α A/Wisconsin [Day 21] (N= 25; 31) | 2.08 Cells per million | Standard Deviation 53.64 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | TNF-α B/Malaysia [Day 0] (N= 29; 32) | 3.09 Cells per million | Standard Deviation 61.5 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | TNF-α Pooled Strains [Day 0] (N= 29; 32) | 2.37 Cells per million | Standard Deviation 82.35 |
| FluAS25 (GSK576389A) Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | TNF-α Pooled Strains [Day 21] (N= 24; 31) | 4.12 Cells per million | Standard Deviation 88.07 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IL-2 Pooled Strains [Day 0] (N= 29; 32) | 6.54 Cells per million | Standard Deviation 69.82 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | All Doubles B/Malaysia [Day 21] (N= 25; 31) | 4.59 Cells per million | Standard Deviation 70.75 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IFN-γ A/Wisconsin [Day 0] (N= 29; 32) | 1.52 Cells per million | Standard Deviation 26.15 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IFN-γ A/Wisconsin [Day 21] (N= 25; 31) | 1.78 Cells per million | Standard Deviation 33.55 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | All Doubles Pooled Strains [Day 21] (N= 24; 31) | 4.16 Cells per million | Standard Deviation 98.01 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | TNF-α A/Wisconsin [Day 21] (N= 25; 31) | 2.03 Cells per million | Standard Deviation 32.51 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | CD40L A/Solomon Islands [Day 0] (N= 30; 32) | 2.38 Cells per million | Standard Deviation 57.63 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IFN-γ B/Malaysia [Day 0] (N= 29; 32) | 2.34 Cells per million | Standard Deviation 63.8 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | CD40L B/Malaysia [Day 0] (N= 29; 32) | 2.03 Cells per million | Standard Deviation 45.49 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | CD40L B/Malaysia [Day 21] (N= 25; 31) | 3.67 Cells per million | Standard Deviation 64.11 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IL-2 Pooled Strains [Day 21] (N= 24; 31) | 3.39 Cells per million | Standard Deviation 91.57 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | CD40L Pooled Strains [Day 0] (N= 29; 32) | 3.65 Cells per million | Standard Deviation 58.75 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IFN-γ B/Malaysia [Day 21] (N= 25; 31) | 1.52 Cells per million | Standard Deviation 22.73 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IL-2 B/Malaysia [Day 21] (N= 25; 31) | 3.72 Cells per million | Standard Deviation 63.72 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | TNF-α Pooled Strains [Day 0] (N= 29; 32) | 1.59 Cells per million | Standard Deviation 50.66 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IFN-γ Pooled Strains [Day 0] (N= 29; 32) | 1.53 Cells per million | Standard Deviation 30.78 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | TNF-α A/Solomon Islands [Day 0] (N= 30; 32) | 2.77 Cells per million | Standard Deviation 101.63 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IFN-γ Pooled Strains [Day 21] (N= 24; 31) | 1.84 Cells per million | Standard Deviation 39.83 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | All Doubles A/Solomon Islands [Day 21] (N= 25; 31) | 3.81 Cells per million | Standard Deviation 52.84 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | TNF-α B/Malaysia [Day 0] (N= 29; 32) | 3.29 Cells per million | Standard Deviation 77.18 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | All Doubles A/Wisconsin [Day 0] (N= 29; 32) | 1.55 Cells per million | Standard Deviation 40.24 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IL-2 A/Solomon Islands [Day 0] (N= 30; 32) | 2.46 Cells per million | Standard Deviation 66.32 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | All Doubles A/Wisconsin [Day 21] (N= 25; 31) | 2.49 Cells per million | Standard Deviation 55.29 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | TNF-α A/Solomon Islands [Day 21] (N= 25; 31) | 2.67 Cells per million | Standard Deviation 36.03 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | All Doubles B/Malaysia [Day 0] (N= 29; 32) | 2.51 Cells per million | Standard Deviation 63.21 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IL-2 A/Solomon Islands [Day 21] (N= 25; 31) | 3.38 Cells per million | Standard Deviation 48.89 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | All Doubles Pooled Strains [Day 0] (N= 29; 32) | 4.43 Cells per million | Standard Deviation 75.73 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | CD40L A/Solomon Islands [Day 21] (N= 25; 31) | 3.17 Cells per million | Standard Deviation 44.66 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | TNF-α B/Malaysia [Day 21] (N= 25; 31) | 1.83 Cells per million | Standard Deviation 34.42 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | CD40L A/Wisconsin [Day 0] (N= 29; 32) | 1.55 Cells per million | Standard Deviation 40.24 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IL-2 A/Wisconsin [Day 0] (N= 29; 32) | 1.76 Cells per million | Standard Deviation 41.38 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | CD40L A/Wisconsin [Day 21] (N= 25; 31) | 1.83 Cells per million | Standard Deviation 41.14 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | TNF-α A/Wisconsin [Day 0] (N= 29; 32) | 1.31 Cells per million | Standard Deviation 18.78 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IL-2 A/Wisconsin [Day 21] (N= 25; 31) | 1.82 Cells per million | Standard Deviation 38.9 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | All Doubles A/Solomon Islands [Day 0] (N= 30; 32) | 3.01 Cells per million | Standard Deviation 124.67 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | CD40L Pooled Strains [Day 21] (N= 24; 31) | 2.91 Cells per million | Standard Deviation 87.43 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IL-2 B/Malaysia [Day 0] (N= 29; 32) | 1.78 Cells per million | Standard Deviation 44.85 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IFN-γ A/Solomon Islands [Day 0] (N= 30; 32) | 1.60 Cells per million | Standard Deviation 123.31 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | TNF-α Pooled Strains [Day 21] (N= 24; 31) | 2.38 Cells per million | Standard Deviation 37.12 |
| Fluarix Group | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | IFN-γ A/Solomon Islands [Day 21] (N= 25; 31) | 1.73 Cells per million | Standard Deviation 23.95 |
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 including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluAS25 (GSK576389A) Group | Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains | A/Wisconsin | 9 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains | A/Solomon Islands | 20 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains | B/Malaysia | 8 Subjects |
| Fluarix Group | Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains | A/Wisconsin | 7 Subjects |
| Fluarix Group | Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains | A/Solomon Islands | 17 Subjects |
| Fluarix Group | Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains | B/Malaysia | 3 Subjects |
Secondary
Number of Subjects Seropositive for HI Antibodies Against Each of the Three Vaccine Strains
A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10. 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 including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluAS25 (GSK576389A) Group | Number of Subjects Seropositive for HI Antibodies Against Each of the Three Vaccine Strains | A/Solomon Islands [Day 0] | 18 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Seropositive for HI Antibodies Against Each of the Three Vaccine Strains | A/Solomon Islands [Day 21] | 29 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Seropositive for HI Antibodies Against Each of the Three Vaccine Strains | A/Wisconsin [Day 0] | 30 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Seropositive for HI Antibodies Against Each of the Three Vaccine Strains | A/Wisconsin [Day 21] | 32 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Seropositive for HI Antibodies Against Each of the Three Vaccine Strains | B/Malaysia [Day 0] | 31 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Seropositive for HI Antibodies Against Each of the Three Vaccine Strains | B/Malaysia [Day 21] | 32 Subjects |
| Fluarix Group | Number of Subjects Seropositive for HI Antibodies Against Each of the Three Vaccine Strains | B/Malaysia [Day 0] | 34 Subjects |
| Fluarix Group | Number of Subjects Seropositive for HI Antibodies Against Each of the Three Vaccine Strains | A/Solomon Islands [Day 0] | 15 Subjects |
| Fluarix Group | Number of Subjects Seropositive for HI Antibodies Against Each of the Three Vaccine Strains | A/Wisconsin [Day 21] | 35 Subjects |
| Fluarix Group | Number of Subjects Seropositive for HI Antibodies Against Each of the Three Vaccine Strains | A/Solomon Islands [Day 21] | 32 Subjects |
| Fluarix Group | Number of Subjects Seropositive for HI Antibodies Against Each of the Three Vaccine Strains | B/Malaysia [Day 21] | 35 Subjects |
| Fluarix Group | Number of Subjects Seropositive for HI Antibodies Against Each of the Three Vaccine Strains | A/Wisconsin [Day 0] | 35 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 to 1:40 that usually is accepted as indicating protection.
Time frame: At Days 0 and 21
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FluAS25 (GSK576389A) Group | Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains | A/Solomon Islands [Day 21] | 27 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains | A/Solomon Islands [Day 0] | 9 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains | B/Malaysia [Day 0] | 20 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains | A/Wisconsin [Day 0] | 29 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains | B/Malaysia [Day 21] | 31 Subjects |
| FluAS25 (GSK576389A) Group | Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains | A/Wisconsin [Day 21] | 32 Subjects |
| Fluarix Group | Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains | B/Malaysia [Day 21] | 34 Subjects |
| Fluarix Group | Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains | A/Solomon Islands [Day 0] | 3 Subjects |
| Fluarix Group | Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains | A/Solomon Islands [Day 21] | 22 Subjects |
| Fluarix Group | Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains | A/Wisconsin [Day 0] | 31 Subjects |
| Fluarix Group | Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains | A/Wisconsin [Day 21] | 35 Subjects |
| Fluarix Group | Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains | B/Malaysia [Day 0] | 29 Subjects |
Secondary
Seroconversion Factors (SCFs) for HI Antibodies Against Each of the Three Vaccine Strains
Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. 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 including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| FluAS25 (GSK576389A) Group | Seroconversion Factors (SCFs) for HI Antibodies Against Each of the Three Vaccine Strains | A/Solomon Islands | 5.0 fold increase |
| FluAS25 (GSK576389A) Group | Seroconversion Factors (SCFs) for HI Antibodies Against Each of the Three Vaccine Strains | A/Wisconsin | 2.5 fold increase |
| FluAS25 (GSK576389A) Group | Seroconversion Factors (SCFs) for HI Antibodies Against Each of the Three Vaccine Strains | B/Malaysia | 2.3 fold increase |
| Fluarix Group | Seroconversion Factors (SCFs) for HI Antibodies Against Each of the Three Vaccine Strains | A/Solomon Islands | 4.7 fold increase |
| Fluarix Group | Seroconversion Factors (SCFs) for HI Antibodies Against Each of the Three Vaccine Strains | A/Wisconsin | 1.9 fold increase |
| Fluarix Group | Seroconversion Factors (SCFs) for HI Antibodies Against Each of the Three Vaccine Strains | B/Malaysia | 1.6 fold increase |
Secondary
Serum Haemagglutination 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 including all evaluable subjects 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 (GSK576389A) Group | Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains | A/Solomon Islands [Day 0] | 12.7 Titer |
| FluAS25 (GSK576389A) Group | Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains | A/Solomon Islands [Day 21] | 63.0 Titer |
| FluAS25 (GSK576389A) Group | Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains | A/Wisconsin [Day 0] | 100.3 Titer |
| FluAS25 (GSK576389A) Group | Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains | A/Wisconsin [Day 21] | 252.2 Titer |
| FluAS25 (GSK576389A) Group | Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains | B/Malaysia [Day 0] | 55.8 Titer |
| FluAS25 (GSK576389A) Group | Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains | B/Malaysia [Day 21] | 126.1 Titer |
| Fluarix Group | Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains | B/Malaysia [Day 0] | 61.2 Titer |
| Fluarix Group | Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains | A/Solomon Islands [Day 0] | 9.0 Titer |
| Fluarix Group | Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains | A/Wisconsin [Day 21] | 158.4 Titer |
| Fluarix Group | Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains | A/Solomon Islands [Day 21] | 42.4 Titer |
| Fluarix Group | Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains | B/Malaysia [Day 21] | 99.4 Titer |
| Fluarix Group | Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains | A/Wisconsin [Day 0] | 83.1 Titer |