Influenza
Conditions
Keywords
immunogenicity, safety, GSK pandemic candidate vaccine
Brief summary
Today, the leading contender for the next influenza pandemic is H5N1, a strain of avian virus found primarily in domestic and wild birds. Experts warn that the next influenza pandemic is imminent and could be severe. Prevention and control will depend on the rapid production and worldwide distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be developed and tested in clinical trials to determine the best formulation and vaccination schedule. The purpose of this study is to assess the immune response of a candidate pandemic vaccine. The protocol posting deals with objectives & outcome measures of the secondary phase of this study. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number = 00449670).
Interventions
BIOLOGICALPandemic influenza vaccine GSK1562902A
IM administration
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 61 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who completed participation in primary phase of this study. * 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. * Healthy subjects as established by medical history and clinical examination before entering into the study. * If the subject is female, she must be of non-childbearing potential or be post-menopausal; if of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.
Exclusion criteria
* Administration of any licensed vaccines within 4 weeks prior to enrolment in this study. * Planned administration of a vaccine not foreseen by the study protocol: 4 weeks prior to any visit or within 30 days after vaccination. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first visit or planned use during the study * Any confirmed or suspected immunosuppressive or immunodeficient condition, or autoimmune diseases such as Guillain Barre Syndrome, based on medical history and physical examination (no laboratory testing required). * History of hypersensitivity to vaccines. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * History of chronic alcohol consumption and/or drug abuse. * Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination. * Acute disease at the time of enrolment. * Administration of immunoglobulins and/or any blood products within the three months preceding the first visit or planned use during the study. * Pregnant or lactating women. * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first visit, or planned use during the study period. * Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Boosted at Month 12 With Haemagglutinin-inhibition (HI) Antibody Concentrations Above the Cut-off Value | At Month 12 + 21 days | Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Indonesia/05/2005. |
| Titers for Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 12 | At Month 12 + 21 days | Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/Indonesia/05/2005. |
| Number of Subjects Boosted at Month 36 With HI Antibody Concentrations Above the Cut-off Value | At Month 36 + 21 days | Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Indonesia/05/2005. |
| Titers for Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 36 | At Month 36 + 21 days | Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/Indonesia/05/2005. |
| Booster Vaccine Response for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 12 | At Month 12 + 21 days | Booster vaccine response was defined as: antibody titer after booster vaccination ≥ 4-fold the pre-booster antibody titer. The Flu strain assessed was A/Indonesia/05/2005 (H5N1). |
| Booster Vaccine Response for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 36 | At Month 36 + 21 Days | Booster vaccine response was defined as: antibody titer after booster vaccination ≥ 4-fold the pre-booster antibody titer. The Flu strain assessed was A/Indonesia/05/2005 (H5N1). |
| Geometric Mean Fold Rise (GMFR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 12 | At Month 12 + 21 days | GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005. |
| Geometric Mean Fold Rise (GMFR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 36 | At Month 36 +21 days | GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005. |
| Number of Subjects Boosted at Month 12 Seroprotected (SPR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease | At Month 12 + 21 days | Seroprotection (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005. |
| Number of Subjects Boosted at Month 36 Seroprotected (SPR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease | At Month 36 + 21 days | Seroprotection (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 7-day (Days 0-6) post-vaccination period - subjects boosted at Month 12 and Month 36 | Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/induration/redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | During the 7-day (Days 0-6) post-vaccination period - subjects boosted at Month 12 and 36 | Assessed solicited general symptoms were arthralgia, fatigue, headache, myalgia, shivering, sweating and fever \[defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects With Adverse Events of Specific Interest (AESIs) | During the entire study period (From Month 12 to Month 48) | An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. |
| Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days | Among cytokines expressed after background reduction were cluster of differentiation 4 all doubles (CD4 all doubles), cluster of differentiation 40-ligand (CD40-L), interferon-gamma (IFN-γ), interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α). The flu strain assessed was H5N1 A/Indonesia/05/2005. |
| Number of Seropositive Subjects for H5N1 HI Antibodies | At Months 18, 24, 30 and 36 | Seropositivity was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:10 against the tested vaccine virus. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004. |
| Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days | Among cytokines expressed after background reduction were cluster of differentiation 8 all doubles (CD8 all doubles), cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). The flu strain assessed was H5N1 A/Indonesia/05/2005. |
| Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days | Among cytokines expressed after background reduction were cluster of differentiation 8 all doubles (CD8 all doubles), cluster of differentiation 40-ligand (CD40-L), interferon-gamma (IFN-γ), interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α). The flu strain assessed was H5N1 A/Vietnam/1194/2004. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | During the 30-day (Days 0-29) follow-up period after vaccination | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs) | During the entire study period (From Month 12 up to Month 48) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days | Among cytokines expressed after background reduction were cluster of differentiation 4 all doubles (CD4 all doubles), cluster of differentiation 40-ligand (CD40-L), interferon-gamma (IFN-γ), interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α). The flu strain assessed was H5N1 A/Vietnam/1194/2004. |
| Booster Vaccine Response for H5N1 HI Antibodies for Subjects Boosted at Month 6 and Month 12 | At Months 18, 24 and 30 | Booster vaccine response was defined as: antibody titer after booster vaccination ≥ 4 fold the pre-booster antibody titer. The Flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004. |
| Number of Subjects Boosted at Month 36 Seroconverted for H5N1 HI Antibodies | At Months 18, 24 and 30 | Seroconversion was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer \< 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004. |
| Booster Vaccine Response for H5N1 HI Antibodies | At Months 36, 42 and 48 | Booster vaccine response was defined as: antibody titer after booster vaccination ≥ 4-fold the pre-booster antibody titer. The Flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004. |
| Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies | At Months 18, 24, 30 | GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004. |
| Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | At Months 18, 24 and 30 | Seroprotection (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004. |
| Titers for Serum Neutralizing Antibodies | At Months 6/12, 6/12 + 21 days, 24, 36 and 48 | Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:28. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004. |
| Booster Vaccine Response for Neutralizing Antibodies | At Months 6/12/36 + 21 days, 12, 24, 36 and 48 | Booster vaccine response was defined as: for pre-booster antibody titer \< 1:28, antibody titer ≥ 1:56 post-booster; for pre-booster, antibody titer ≥ 1:28, post-booster ≥ 4-fold the pre-booster antibody titer. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004. |
| Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | At Months 6/12/36 + 21 days, 12, 24, 36 and 48 | Seropositivity cut-off values assessed were equal to or above (≥) 1:28, ≥ 1:56 and ≥ 1:112 in the sera of subjects seronegative before vaccination. The flu strain assessed was A/Indonesia/05/2005. |
| Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | At Months 6/12/36 + 21 days, 12, 24, 36 and 48 | Seropositivity cut-off values assessed were equal to or above (≥) 1:28, ≥ 1:56 and ≥ 1:112 in the sera of subjects seronegative before vaccination. The flu strain assessed was A/Vietnam/1194/2004. |
Countries
Hong Kong, Singapore, Taiwan, Thailand
Participant flow
Pre-assignment details
One enrolled subject was not administered a booster vaccination and hence not considered to have started the study.
Participants by arm
| Arm | Count |
|---|---|
| GSK1562902A M6 Group Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) and boosted 6 months (M6) after primary vaccination with one dose of Pandemic influenza candidate vaccine (GSK1562902A) in study 109630 (NCT00449670), administrated intramuscularly (IM) in the deltoid region of the non-dominant arm. | 219 |
| GSK1562902A M12 Group Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm. | 188 |
| GSK1562902A M36 Group Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm. | 437 |
| Total | 844 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Months 12-18 | Lost to Follow-up | 1 | 2 | 7 |
| Months 24-30 | Other | 5 | 1 | 11 |
| Months 36-42 | Lost to Follow-up | 0 | 1 | 0 |
| Months 36-42 | Migrated/moved from study area | 1 | 0 | 0 |
| Months 36-42 | Other | 4 | 2 | 8 |
| Months 36-42 | Serious Adverse Events | 0 | 1 | 1 |
| Months 36-42 | Withdrawal by Subject | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | GSK1562902A M12 Group | GSK1562902A M36 Group | Total | GSK1562902A M6 Group |
|---|---|---|---|---|
| Age, Continuous | 35.3 Years STANDARD_DEVIATION 9.23 | 35.4 Years STANDARD_DEVIATION 9.71 | 34.93 Years STANDARD_DEVIATION 9.75 | 34.1 Years STANDARD_DEVIATION 10.33 |
| Race and Ethnicity Not Collected | — | — | 0 Participants | — |
| Sex: Female, Male Female | 97 Participants | 210 Participants | 420 Participants | 113 Participants |
| Sex: Female, Male Male | 91 Participants | 227 Participants | 424 Participants | 106 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 219 | 0 / 188 | 0 / 437 |
| other Total, other adverse events | 0 / 0 | 169 / 188 | 336 / 437 |
| serious Total, serious adverse events | 14 / 219 | 13 / 188 | 28 / 437 |
Outcome results
Primary
Booster Vaccine Response for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 12
Booster vaccine response was defined as: antibody titer after booster vaccination ≥ 4-fold the pre-booster antibody titer. The Flu strain assessed was A/Indonesia/05/2005 (H5N1).
Time frame: At Month 12 + 21 days
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1562902A M12 Group | Booster Vaccine Response for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 12 | 169 Participants |
Primary
Booster Vaccine Response for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 36
Booster vaccine response was defined as: antibody titer after booster vaccination ≥ 4-fold the pre-booster antibody titer. The Flu strain assessed was A/Indonesia/05/2005 (H5N1).
Time frame: At Month 36 + 21 Days
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1562902A M12 Group | Booster Vaccine Response for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 36 | 378 Participants |
Primary
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 12
GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005.
Time frame: At Month 12 + 21 days
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK1562902A M12 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 12 | 55.3 Fold change |
Primary
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 36
GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005.
Time frame: At Month 36 +21 days
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK1562902A M12 Group | Geometric Mean Fold Rise (GMFR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 36 | 123.8 Fold change |
Primary
Number of Subjects Boosted at Month 12 Seroprotected (SPR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease
Seroprotection (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005.
Time frame: At Month 12 + 21 days
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1562902A M12 Group | Number of Subjects Boosted at Month 12 Seroprotected (SPR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease | 178 Participants |
Primary
Number of Subjects Boosted at Month 12 With Haemagglutinin-inhibition (HI) Antibody Concentrations Above the Cut-off Value
Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Indonesia/05/2005.
Time frame: At Month 12 + 21 days
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1562902A M12 Group | Number of Subjects Boosted at Month 12 With Haemagglutinin-inhibition (HI) Antibody Concentrations Above the Cut-off Value | 178 Participants |
Primary
Number of Subjects Boosted at Month 36 Seroprotected (SPR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease
Seroprotection (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005.
Time frame: At Month 36 + 21 days
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1562902A M12 Group | Number of Subjects Boosted at Month 36 Seroprotected (SPR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease | 379 Participants |
Primary
Number of Subjects Boosted at Month 36 With HI Antibody Concentrations Above the Cut-off Value
Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Indonesia/05/2005.
Time frame: At Month 36 + 21 days
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1562902A M12 Group | Number of Subjects Boosted at Month 36 With HI Antibody Concentrations Above the Cut-off Value | 379 Participants |
Primary
Titers for Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 12
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/Indonesia/05/2005.
Time frame: At Month 12 + 21 days
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK1562902A M12 Group | Titers for Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 12 | 340.3 Titers |
Primary
Titers for Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 36
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/Indonesia/05/2005.
Time frame: At Month 36 + 21 days
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK1562902A M12 Group | Titers for Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 36 | 877.5 Titers |
Secondary
Booster Vaccine Response for H5N1 HI Antibodies
Booster vaccine response was defined as: antibody titer after booster vaccination ≥ 4-fold the pre-booster antibody titer. The Flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
Time frame: At Months 36, 42 and 48
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1562902A M12 Group | Booster Vaccine Response for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 36 | 91 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 42 | 59 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 48 | 62 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 36 | 28 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 42 | 22 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 48 | 28 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 48 | 75 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 36 | 115 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 36 | 82 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 42 | 69 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 42 | 89 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 48 | 88 Participants |
| GSK1562902A M36 Group | Booster Vaccine Response for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 42 | 0 Participants |
| GSK1562902A M36 Group | Booster Vaccine Response for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 48 | 339 Participants |
| GSK1562902A M36 Group | Booster Vaccine Response for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 48 | 319 Participants |
| GSK1562902A M36 Group | Booster Vaccine Response for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 36 | 0 Participants |
| GSK1562902A M36 Group | Booster Vaccine Response for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 36 | 0 Participants |
| GSK1562902A M36 Group | Booster Vaccine Response for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 42 | 0 Participants |
Secondary
Booster Vaccine Response for H5N1 HI Antibodies for Subjects Boosted at Month 6 and Month 12
Booster vaccine response was defined as: antibody titer after booster vaccination ≥ 4 fold the pre-booster antibody titer. The Flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
Time frame: At Months 18, 24 and 30
Population: The analysis was performed on the ATP cohort for persistence at Month 12-18 and at Month 24-30, which included all evaluable subjects not boosted and boosted at Month 12, not boosted at Month 12 but boosted at Month 6 or neither boosted at Month 6 nor at Month 12.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1562902A M12 Group | Booster Vaccine Response for H5N1 HI Antibodies for Subjects Boosted at Month 6 and Month 12 | A/Indonesia/05/2005, Month 18 | 149 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for H5N1 HI Antibodies for Subjects Boosted at Month 6 and Month 12 | A/Indonesia/05/2005, Month 24 | 48 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for H5N1 HI Antibodies for Subjects Boosted at Month 6 and Month 12 | A/Indonesia/05/2005, Month 30 | 52 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for H5N1 HI Antibodies for Subjects Boosted at Month 6 and Month 12 | A/Vietnam/1194/2004, Month 18 | 68 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for H5N1 HI Antibodies for Subjects Boosted at Month 6 and Month 12 | A/Vietnam/1194/2004, Month 24 | 32 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for H5N1 HI Antibodies for Subjects Boosted at Month 6 and Month 12 | A/Vietnam/1194/2004, Month 30 | 28 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for H5N1 HI Antibodies for Subjects Boosted at Month 6 and Month 12 | A/Vietnam/1194/2004, Month 18 | 0 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for H5N1 HI Antibodies for Subjects Boosted at Month 6 and Month 12 | A/Indonesia/05/2005, Month 18 | 0 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for H5N1 HI Antibodies for Subjects Boosted at Month 6 and Month 12 | A/Vietnam/1194/2004, Month 30 | 51 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for H5N1 HI Antibodies for Subjects Boosted at Month 6 and Month 12 | A/Indonesia/05/2005, Month 24 | 70 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for H5N1 HI Antibodies for Subjects Boosted at Month 6 and Month 12 | A/Vietnam/1194/2004, Month 24 | 61 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for H5N1 HI Antibodies for Subjects Boosted at Month 6 and Month 12 | A/Indonesia/05/2005, Month 30 | 69 Participants |
Secondary
Booster Vaccine Response for Neutralizing Antibodies
Booster vaccine response was defined as: for pre-booster antibody titer \< 1:28, antibody titer ≥ 1:56 post-booster; for pre-booster, antibody titer ≥ 1:28, post-booster ≥ 4-fold the pre-booster antibody titer. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
Time frame: At Months 6/12/36 + 21 days, 12, 24, 36 and 48
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1562902A M12 Group | Booster Vaccine Response for Neutralizing Antibodies | A/Indonesia/05/2005, Month 12 | 4 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for Neutralizing Antibodies | A/Indonesia/05/2005, Month 24 | 0 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for Neutralizing Antibodies | A/Indonesia/05/2005, Month 36 | 0 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for Neutralizing Antibodies | A/Indonesia/05/2005, Month 48 | 1 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for Neutralizing Antibodies | A/Indonesia/05/2005, Month 6/12/36 + 21 days | 144 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for Neutralizing Antibodies | A/Vietnam/1194/2004, Month 12 | 7 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for Neutralizing Antibodies | A/Vietnam/1194/2004, Month 24 | 1 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for Neutralizing Antibodies | A/Vietnam/1194/2004, Month 36 | 0 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for Neutralizing Antibodies | A/Vietnam/1194/2004, Month 48 | 0 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for Neutralizing Antibodies | A/Vietnam/1194/2004, Month 6/12/36 + 21 days | 121 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for Neutralizing Antibodies | A/Vietnam/1194/2004, Month 48 | 2 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for Neutralizing Antibodies | A/Indonesia/05/2005, Month 12 | 0 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for Neutralizing Antibodies | A/Vietnam/1194/2004, Month 12 | 0 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for Neutralizing Antibodies | A/Indonesia/05/2005, Month 6/12/36 + 21 days | 159 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for Neutralizing Antibodies | A/Indonesia/05/2005, Month 24 | 34 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for Neutralizing Antibodies | A/Vietnam/1194/2004, Month 6/12/36 + 21 days | 141 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for Neutralizing Antibodies | A/Vietnam/1194/2004, Month 36 | 5 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for Neutralizing Antibodies | A/Indonesia/05/2005, Month 36 | 27 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for Neutralizing Antibodies | A/Vietnam/1194/2004, Month 24 | 7 Participants |
| GSK1562902A M12 Group | Booster Vaccine Response for Neutralizing Antibodies | A/Indonesia/05/2005, Month 48 | 27 Participants |
| GSK1562902A M36 Group | Booster Vaccine Response for Neutralizing Antibodies | A/Vietnam/1194/2004, Month 36 | 0 Participants |
| GSK1562902A M36 Group | Booster Vaccine Response for Neutralizing Antibodies | A/Indonesia/05/2005, Month 48 | 72 Participants |
| GSK1562902A M36 Group | Booster Vaccine Response for Neutralizing Antibodies | A/Indonesia/05/2005, Month 6/12/36 + 21 days | 75 Participants |
| GSK1562902A M36 Group | Booster Vaccine Response for Neutralizing Antibodies | A/Vietnam/1194/2004, Month 12 | 0 Participants |
| GSK1562902A M36 Group | Booster Vaccine Response for Neutralizing Antibodies | A/Vietnam/1194/2004, Month 48 | 64 Participants |
| GSK1562902A M36 Group | Booster Vaccine Response for Neutralizing Antibodies | A/Vietnam/1194/2004, Month 24 | 0 Participants |
| GSK1562902A M36 Group | Booster Vaccine Response for Neutralizing Antibodies | A/Indonesia/05/2005, Month 12 | 0 Participants |
| GSK1562902A M36 Group | Booster Vaccine Response for Neutralizing Antibodies | A/Vietnam/1194/2004, Month 6/12/36 + 21 days | 73 Participants |
| GSK1562902A M36 Group | Booster Vaccine Response for Neutralizing Antibodies | A/Indonesia/05/2005, Month 24 | 0 Participants |
| GSK1562902A M36 Group | Booster Vaccine Response for Neutralizing Antibodies | A/Indonesia/05/2005, Month 36 | 0 Participants |
Secondary
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain)
Among cytokines expressed after background reduction were cluster of differentiation 4 all doubles (CD4 all doubles), cluster of differentiation 40-ligand (CD40-L), interferon-gamma (IFN-γ), interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α). The flu strain assessed was H5N1 A/Indonesia/05/2005.
Time frame: At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-CD40L, Month 42 | 1656.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-All doubles, Month 18 | 2060.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IL-2, Month 24 | 2423.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-CD40L, Month 48 | 1496.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-All doubles, Month 6 | 1119.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IL-2, Month 18 | 1990.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-CD40L, Month 6/12/36 + 21 days | 5292.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-All doubles, Month 42 | 1656.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IL-2, Month 12 | 2580.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IFN-γ, Month 6 | 537.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-All doubles, Month 12 | 2620.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IL-2, Month 6 | 883.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IFN-γ, Month 12 | 1217.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-TNF-α, Month 24 | 2084.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IFN-γ, Month 6/12/36 + 21 days | 3255.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IFN-γ, Month 18 | 989.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-All doubles, Month 48 | 1496.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IFN-γ, Month 48 | 964.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IFN-γ, Month 24 | 1590.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-TNF-α, Month 42 | 1218.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IFN-γ, Month 42 | 698.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IFN-γ, Month 30 | 1829.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-TNF-α, Month 18 | 1462.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IFN-γ, Month 36 | 1026.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-All doubles, Month 6/12/36 + 21 days | 5401.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-All doubles, Month 24 | 2565.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-TNF-α, Month 12 | 2528.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-CD40L, Month 6 | 1045.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-TNF-α, Month 6/12/36 + 21 days | 4249.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-TNF-α, Month 6 | 909.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-CD40L, Month 12 | 2634.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-TNF-α, Month 36 | 1476.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IL-2, Month 6/12/36 + 21 days | 4972.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-CD40L, Month 18 | 2025.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-All doubles, Month 30 | 3147.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IL-2, Month 48 | 1373.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-CD40L, Month 24 | 2583.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-TNF-α, Month 48 | 1169.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IL-2, Month 42 | 1533.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-CD40L, Month 30 | 3113.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-TNF-α, Month 30 | 2442.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IL-2, Month 36 | 1490.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-CD40L, Month 36 | 1683.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-All doubles, Month 36 | 1689.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IL-2, Month 30 | 2830.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-TNF-α, Month 24 | 2972.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-All doubles, Month 6 | 1862.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-All doubles, Month 12 | 1599.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-All doubles, Month 18 | 2335.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-All doubles, Month 24 | 3517.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-All doubles, Month 30 | 3907.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-All doubles, Month 36 | 2506.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-All doubles, Month 42 | 2311.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-All doubles, Month 48 | 2054.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-All doubles, Month 6/12/36 + 21 days | 9553.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-CD40L, Month 6 | 1792.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-CD40L, Month 12 | 1494.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-CD40L, Month 18 | 2240.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-CD40L, Month 24 | 3435.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-CD40L, Month 30 | 3652.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-CD40L, Month 36 | 2453.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-CD40L, Month 42 | 2243.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-CD40L, Month 48 | 2013.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-CD40L, Month 6/12/36 + 21 days | 9416.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IFN-γ, Month 6 | 1189.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IFN-γ, Month 12 | 994.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IFN-γ, Month 18 | 1306.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IFN-γ, Month 24 | 2036.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IFN-γ, Month 30 | 1892.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IFN-γ, Month 36 | 1452.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IFN-γ, Month 42 | 1336.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IFN-γ, Month 48 | 1085.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IFN-γ, Month 6/12/36 + 21 days | 4661.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IL-2, Month 6 | 1657.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IL-2, Month 12 | 1649.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IL-2, Month 18 | 2297.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IL-2, Month 24 | 3256.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IL-2, Month 30 | 3459.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IL-2, Month 36 | 2247.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IL-2, Month 42 | 2123.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IL-2, Month 48 | 1906.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IL-2, Month 6/12/36 + 21 days | 8993.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-TNF-α, Month 6 | 1644.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-TNF-α, Month 12 | 1515.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-TNF-α, Month 18 | 1810.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-TNF-α, Month 30 | 3247.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-TNF-α, Month 36 | 2291.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-TNF-α, Month 42 | 1901.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-TNF-α, Month 48 | 1769.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-TNF-α, Month 6/12/36 + 21 days | 8466.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-CD40L, Month 42 | 2142.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-TNF-α, Month 6/12/36 + 21 days | 3726.50 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IL-2, Month 24 | 1187.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-CD40L, Month 36 | 975.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-TNF-α, Month 30 | 1269.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IL-2, Month 30 | 1506.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-CD40L, Month 30 | 1685.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-All doubles, Month 24 | 1396.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IL-2, Month 36 | 846.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-CD40L, Month 24 | 1395.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-TNF-α, Month 48 | 1794.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IL-2, Month 42 | 2072.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-CD40L, Month 18 | 1518.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-TNF-α, Month 36 | 917.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IL-2, Month 48 | 1926.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-CD40L, Month 12 | 1372.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-All doubles, Month 18 | 1590.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IL-2, Month 6/12/36 + 21 days | 4532.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-CD40L, Month 6 | 2829.50 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-All doubles, Month 6 | 3109.50 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-TNF-α, Month 6 | 2579.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-All doubles, Month 6/12/36 + 21 days | 5057.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-TNF-α, Month 42 | 1675.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-TNF-α, Month 12 | 1174.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IFN-γ, Month 30 | 1096.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-All doubles, Month 48 | 2064.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IFN-γ, Month 36 | 543.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IFN-γ, Month 24 | 787.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-All doubles, Month 12 | 1443.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IFN-γ, Month 42 | 1119.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IFN-γ, Month 18 | 959.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-TNF-α, Month 18 | 1160.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IFN-γ, Month 48 | 1334.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IFN-γ, Month 12 | 852.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-All doubles, Month 42 | 2129.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IFN-γ, Month 6/12/36 + 21 days | 2077.50 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IFN-γ, Month 6 | 2134.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-All doubles, Month 36 | 995.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IL-2, Month 6 | 2799.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-CD40L, Month 6/12/36 + 21 days | 5038.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-TNF-α, Month 24 | 1107.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IL-2, Month 12 | 1335.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-CD40L, Month 48 | 2008.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-All doubles, Month 30 | 1670.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD4-IL-2, Month 18 | 1224.00 T-cells/million cells |
Secondary
Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain)
Among cytokines expressed after background reduction were cluster of differentiation 4 all doubles (CD4 all doubles), cluster of differentiation 40-ligand (CD40-L), interferon-gamma (IFN-γ), interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α). The flu strain assessed was H5N1 A/Vietnam/1194/2004.
Time frame: At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-All doubles, Month 12 | 2410.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IFN-γ, Month 42 | 547.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-CD40L, Month 30 | 2882.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-All doubles, Month 18 | 2505.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IFN-γ, Month 6 | 826.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-CD40L, Month 24 | 2735.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-All doubles, Month 24 | 2720.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IL-2, Month 12 | 2305.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-TNF-α, Month 18 | 2258.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-All doubles, Month 30 | 2959.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IFN-γ, Month 36 | 813.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-TNF-α, Month 12 | 1784.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-All doubles, Month 36 | 1420.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-TNF-α, Month 6/12/36 + 21 days | 5527.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-CD40L, Month 18 | 2517.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-All doubles, Month 42 | 1354.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IL-2, Month 18 | 2431.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-CD40L, Month 12 | 2384.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-All doubles, Month 48 | 1600.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IFN-γ, Month 24 | 1659.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-CD40L, Month 6 | 1586.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-All doubles, Month 6/12/36 + 21 days | 7067.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-TNF-α, Month 48 | 1376.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IL-2, Month 24 | 2598.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IFN-γ, Month 48 | 749.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-TNF-α, Month 42 | 1094.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IL-2, Month 30 | 2773.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-TNF-α, Month 6 | 1280.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-TNF-α, Month 36 | 1145.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IL-2, Month 36 | 1301.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IFN-γ, Month 18 | 1395.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-TNF-α, Month 30 | 2191.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IL-2, Month 42 | 1218.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IFN-γ, Month 6/12/36 + 21 days | 3608.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-TNF-α, Month 24 | 1871.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IL-2, Month 48 | 1169.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IFN-γ, Month 30 | 1885.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-CD40L, Month 6/12/36 + 21 days | 6931.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IL-2, Month 6/12/36 + 21 days | 6557.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IFN-γ, Month 12 | 1108.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-CD40L, Month 48 | 1618.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-CD40L, Month 42 | 1340.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-All doubles, Month 6 | 1615.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IL-2, Month 6 | 1493.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-CD40L, Month 36 | 1406.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-TNF-α, Month 6 | 1768.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IFN-γ, Month 36 | 1260.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IFN-γ, Month 42 | 1218.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IFN-γ, Month 48 | 1007.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IFN-γ, Month 6/12/36 + 21 days | 4918.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IL-2, Month 6 | 1957.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IL-2, Month 12 | 1729.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IL-2, Month 18 | 4073.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IL-2, Month 24 | 3799.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IL-2, Month 30 | 3537.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IL-2, Month 36 | 2240.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IL-2, Month 42 | 2179.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IL-2, Month 48 | 1931.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IL-2, Month 6/12/36 + 21 days | 9252.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-All doubles, Month 6 | 2133.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-All doubles, Month 12 | 1889.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-All doubles, Month 18 | 4073.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-All doubles, Month 24 | 3945.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-All doubles, Month 30 | 3713.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-All doubles, Month 36 | 2149.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-All doubles, Month 42 | 2264.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-All doubles, Month 48 | 2087.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-All doubles, Month 6/12/36 + 21 days | 10061.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-CD40L, Month 6 | 1998.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-CD40L, Month 12 | 1863.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-CD40L, Month 18 | 3980.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-TNF-α, Month 12 | 1488.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-TNF-α, Month 18 | 3357.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-CD40L, Month 24 | 3932.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-CD40L, Month 30 | 3607.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-CD40L, Month 36 | 2122.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-CD40L, Month 42 | 2265.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-CD40L, Month 48 | 2008.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-CD40L, Month 6/12/36 + 21 days | 9587.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-TNF-α, Month 24 | 3252.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-TNF-α, Month 30 | 3246.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-TNF-α, Month 36 | 1935.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-TNF-α, Month 42 | 1819.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-TNF-α, Month 48 | 1737.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-TNF-α, Month 6/12/36 + 21 days | 7385.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IFN-γ, Month 6 | 999.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IFN-γ, Month 12 | 884.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IFN-γ, Month 18 | 1927.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IFN-γ, Month 24 | 2439.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IFN-γ, Month 30 | 2248.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IL-2, Month 6 | 2910.50 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-CD40L, Month 36 | 1098.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-TNF-α, Month 6 | 2540.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IFN-γ, Month 30 | 1074.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-CD40L, Month 42 | 2502.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IL-2, Month 6/12/36 + 21 days | 4759.50 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IFN-γ, Month 6 | 1420.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-CD40L, Month 48 | 2332.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IL-2, Month 48 | 2218.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IFN-γ, Month 6/12/36 + 21 days | 2142.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-CD40L, Month 6/12/36 + 21 days | 5296.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-TNF-α, Month 18 | 1392.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IL-2, Month 42 | 2323.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IFN-γ, Month 24 | 847.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-TNF-α, Month 24 | 1131.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IL-2, Month 36 | 891.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IFN-γ, Month 12 | 869.50 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-TNF-α, Month 30 | 1246.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IL-2, Month 30 | 1344.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IFN-γ, Month 48 | 1223.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-TNF-α, Month 36 | 829.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IL-2, Month 24 | 1454.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IFN-γ, Month 36 | 621.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-All doubles, Month 6/12/36 + 21 days | 5315.50 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-All doubles, Month 48 | 2332.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-TNF-α, Month 42 | 1863.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-CD40L, Month 6 | 2937.50 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-All doubles, Month 42 | 2555.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IL-2, Month 18 | 1592.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-CD40L, Month 12 | 1741.50 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-All doubles, Month 36 | 1097.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IFN-γ, Month 18 | 941.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-CD40L, Month 18 | 1607.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-All doubles, Month 30 | 1478.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-TNF-α, Month 48 | 1781.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-TNF-α, Month 12 | 1404.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-All doubles, Month 24 | 1472.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IL-2, Month 12 | 1759.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-All doubles, Month 18 | 1658.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-IFN-γ, Month 42 | 1228.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-CD40L, Month 24 | 1490.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-All doubles, Month 12 | 1849.50 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-TNF-α, Month 6/12/36 + 21 days | 3899.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-CD40L, Month 30 | 1449.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD4-All doubles, Month 6 | 3047.00 T-cells/million cells |
Secondary
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain)
Among cytokines expressed after background reduction were cluster of differentiation 8 all doubles (CD8 all doubles), cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α). The flu strain assessed was H5N1 A/Indonesia/05/2005.
Time frame: At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-CD40L, Month 42 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-All doubles, Month 18 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IL-2, Month 24 | 5.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-CD40L, Month 48 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-All doubles, Month 6 | 34.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IL-2, Month 18 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-CD40L, Month 6/12/36 + 21 days | 78.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-All doubles, Month 42 | 19.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IL-2, Month 12 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IFN-γ, Month 6 | 22.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-All doubles, Month 12 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IL-2, Month 6 | 12.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IFN-γ, Month 12 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-TNF-α, Month 24 | 17.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IFN-γ, Month 6/12/36 + 21 days | 59.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IFN-γ, Month 18 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-All doubles, Month 48 | 30.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IFN-γ, Month 48 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IFN-γ, Month 24 | 23.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-TNF-α, Month 42 | 19.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IFN-γ, Month 42 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IFN-γ, Month 30 | 2.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-TNF-α, Month 18 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IFN-γ, Month 36 | 38.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-All doubles, Month 6/12/36 + 21 days | 73.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-All doubles, Month 24 | 23.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-TNF-α, Month 12 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-CD40L, Month 6 | 34.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-TNF-α, Month 6/12/36 + 21 days | 26.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-TNF-α, Month 6 | 12.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-CD40L, Month 12 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-TNF-α, Month 36 | 14.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IL-2, Month 6/12/36 + 21 days | 28.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-CD40L, Month 18 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-All doubles, Month 30 | 2.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IL-2, Month 48 | 30.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-CD40L, Month 24 | 55.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-TNF-α, Month 48 | 30.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IL-2, Month 42 | 19.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-CD40L, Month 30 | 3.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-TNF-α, Month 30 | 8.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IL-2, Month 36 | 38.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-CD40L, Month 36 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-All doubles, Month 36 | 38.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IL-2, Month 30 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-TNF-α, Month 24 | 78.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-All doubles, Month 6 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-All doubles, Month 12 | 26.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-All doubles, Month 18 | 120.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-All doubles, Month 24 | 51.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-All doubles, Month 30 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-All doubles, Month 36 | 17.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-All doubles, Month 42 | 3.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-All doubles, Month 48 | 20.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-All doubles, Month 6/12/36 + 21 days | 159.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-CD40L, Month 6 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-CD40L, Month 12 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-CD40L, Month 18 | 9.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-CD40L, Month 24 | 32.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-CD40L, Month 30 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-CD40L, Month 36 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-CD40L, Month 42 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-CD40L, Month 48 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-CD40L, Month 6/12/36 + 21 days | 28.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IFN-γ, Month 6 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IFN-γ, Month 12 | 54.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IFN-γ, Month 18 | 120.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IFN-γ, Month 24 | 30.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IFN-γ, Month 30 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IFN-γ, Month 36 | 25.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IFN-γ, Month 42 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IFN-γ, Month 48 | 29.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IFN-γ, Month 6/12/36 + 21 days | 93.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IL-2, Month 6 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IL-2, Month 12 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IL-2, Month 18 | 47.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IL-2, Month 24 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IL-2, Month 30 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IL-2, Month 36 | 17.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IL-2, Month 42 | 13.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IL-2, Month 48 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IL-2, Month 6/12/36 + 21 days | 144.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-TNF-α, Month 6 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-TNF-α, Month 12 | 28.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-TNF-α, Month 18 | 60.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-TNF-α, Month 30 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-TNF-α, Month 36 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-TNF-α, Month 42 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-TNF-α, Month 48 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-TNF-α, Month 6/12/36 + 21 days | 112.50 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-CD40L, Month 42 | 1.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-TNF-α, Month 6/12/36 + 21 days | 46.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IL-2, Month 24 | 39.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-CD40L, Month 36 | 1.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-TNF-α, Month 30 | 36.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IL-2, Month 30 | 16.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-CD40L, Month 30 | 1.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-All doubles, Month 24 | 88.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IL-2, Month 36 | 20.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-CD40L, Month 24 | 61.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-TNF-α, Month 48 | 1.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IL-2, Month 42 | 1.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-CD40L, Month 18 | 1.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-TNF-α, Month 36 | 1.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IL-2, Month 48 | 1.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-CD40L, Month 12 | 1.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-All doubles, Month 18 | 27.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IL-2, Month 6/12/36 + 21 days | 35.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-CD40L, Month 6 | 3.50 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-All doubles, Month 6 | 14.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-TNF-α, Month 6 | 50.50 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-All doubles, Month 6/12/36 + 21 days | 45.50 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-TNF-α, Month 42 | 1.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-TNF-α, Month 12 | 31.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IFN-γ, Month 30 | 18.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-All doubles, Month 48 | 1.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IFN-γ, Month 36 | 20.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IFN-γ, Month 24 | 95.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-All doubles, Month 12 | 44.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IFN-γ, Month 42 | 1.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IFN-γ, Month 18 | 27.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-TNF-α, Month 18 | 10.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IFN-γ, Month 48 | 1.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IFN-γ, Month 12 | 1.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-All doubles, Month 42 | 1.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IFN-γ, Month 6/12/36 + 21 days | 35.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IFN-γ, Month 6 | 8.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-All doubles, Month 36 | 35.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IL-2, Month 6 | 32.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-CD40L, Month 6/12/36 + 21 days | 30.50 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-TNF-α, Month 24 | 76.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IL-2, Month 12 | 31.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-CD40L, Month 48 | 1.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-All doubles, Month 30 | 37.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain) | CD8-IL-2, Month 18 | 27.50 T-cells/million cells |
Secondary
Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain)
Among cytokines expressed after background reduction were cluster of differentiation 8 all doubles (CD8 all doubles), cluster of differentiation 40-ligand (CD40-L), interferon-gamma (IFN-γ), interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α). The flu strain assessed was H5N1 A/Vietnam/1194/2004.
Time frame: At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-CD40L, Month 42 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-All doubles, Month 18 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IL-2, Month 24 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-CD40L, Month 48 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-All doubles, Month 6 | 33.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IL-2, Month 18 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-CD40L, Month 6/12/36 + 21 days | 10.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-All doubles, Month 42 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IL-2, Month 12 | 25.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IFN-γ, Month 6 | 33.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-All doubles, Month 12 | 26.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IL-2, Month 6 | 3.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IFN-γ, Month 12 | 18.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-TNF-α, Month 24 | 45.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IFN-γ, Month 6/12/36 + 21 days | 27.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IFN-γ, Month 18 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-All doubles, Month 48 | 12.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IFN-γ, Month 48 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IFN-γ, Month 24 | 10.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-TNF-α, Month 42 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IFN-γ, Month 42 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IFN-γ, Month 30 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-TNF-α, Month 18 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IFN-γ, Month 36 | 23.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-All doubles, Month 6/12/36 + 21 days | 32.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-All doubles, Month 24 | 28.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-TNF-α, Month 12 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-CD40L, Month 6 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-TNF-α, Month 6/12/36 + 21 days | 15.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-TNF-α, Month 6 | 29.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-CD40L, Month 12 | 12.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-TNF-α, Month 36 | 23.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IL-2, Month 6/12/36 + 21 days | 23.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-CD40L, Month 18 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-All doubles, Month 30 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IL-2, Month 48 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-CD40L, Month 24 | 21.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-TNF-α, Month 48 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IL-2, Month 42 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-CD40L, Month 30 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-TNF-α, Month 30 | 10.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IL-2, Month 36 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-CD40L, Month 36 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-All doubles, Month 36 | 18.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IL-2, Month 30 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-TNF-α, Month 24 | 37.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-All doubles, Month 6 | 69.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-All doubles, Month 12 | 24.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-All doubles, Month 18 | 63.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-All doubles, Month 24 | 33.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-All doubles, Month 30 | 46.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-All doubles, Month 36 | 96.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-All doubles, Month 42 | 35.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-All doubles, Month 48 | 1.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-All doubles, Month 6/12/36 + 21 days | 133.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-CD40L, Month 6 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-CD40L, Month 12 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-CD40L, Month 18 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-CD40L, Month 24 | 33.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-CD40L, Month 30 | 31.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-CD40L, Month 36 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-CD40L, Month 42 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-CD40L, Month 48 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-CD40L, Month 6/12/36 + 21 days | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IFN-γ, Month 6 | 22.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IFN-γ, Month 12 | 67.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IFN-γ, Month 18 | 30.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IFN-γ, Month 24 | 33.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IFN-γ, Month 30 | 46.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IFN-γ, Month 36 | 96.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IFN-γ, Month 42 | 35.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IFN-γ, Month 48 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IFN-γ, Month 6/12/36 + 21 days | 81.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IL-2, Month 6 | 67.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IL-2, Month 12 | 53.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IL-2, Month 18 | 47.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IL-2, Month 24 | 12.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IL-2, Month 30 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IL-2, Month 36 | 64.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IL-2, Month 42 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IL-2, Month 48 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IL-2, Month 6/12/36 + 21 days | 103.50 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-TNF-α, Month 6 | 25.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-TNF-α, Month 12 | 24.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-TNF-α, Month 18 | 63.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-TNF-α, Month 30 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-TNF-α, Month 36 | 111.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-TNF-α, Month 42 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-TNF-α, Month 48 | 1.00 T-cells/million cells |
| GSK1562902A M12 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-TNF-α, Month 6/12/36 + 21 days | 127.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-CD40L, Month 42 | 1.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-TNF-α, Month 6/12/36 + 21 days | 7.50 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IL-2, Month 24 | 51.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-CD40L, Month 36 | 4.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-TNF-α, Month 30 | 39.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IL-2, Month 30 | 19.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-CD40L, Month 30 | 1.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-All doubles, Month 24 | 52.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IL-2, Month 36 | 1.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-CD40L, Month 24 | 17.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-TNF-α, Month 48 | 20.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IL-2, Month 42 | 20.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-CD40L, Month 18 | 1.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-TNF-α, Month 36 | 1.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IL-2, Month 48 | 1.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-CD40L, Month 12 | 1.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-All doubles, Month 18 | 30.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IL-2, Month 6/12/36 + 21 days | 39.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-CD40L, Month 6 | 1.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-All doubles, Month 6 | 1.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-TNF-α, Month 6 | 32.50 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-All doubles, Month 6/12/36 + 21 days | 33.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-TNF-α, Month 42 | 20.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-TNF-α, Month 12 | 39.50 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IFN-γ, Month 30 | 1.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-All doubles, Month 48 | 19.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IFN-γ, Month 36 | 4.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IFN-γ, Month 24 | 51.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-All doubles, Month 12 | 24.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IFN-γ, Month 42 | 20.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IFN-γ, Month 18 | 2.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-TNF-α, Month 18 | 19.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IFN-γ, Month 48 | 35.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IFN-γ, Month 12 | 30.50 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-All doubles, Month 42 | 26.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IFN-γ, Month 6/12/36 + 21 days | 25.50 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IFN-γ, Month 6 | 1.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-All doubles, Month 36 | 30.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IL-2, Month 6 | 28.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-CD40L, Month 6/12/36 + 21 days | 1.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-TNF-α, Month 24 | 77.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IL-2, Month 12 | 7.50 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-CD40L, Month 48 | 1.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-All doubles, Month 30 | 4.00 T-cells/million cells |
| GSK1562902A M36 Group | Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain) | CD8-IL-2, Month 18 | 2.00 T-cells/million cells |
Secondary
Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies
GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
Time frame: At Months 36, 42 and 48
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included 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) |
|---|---|---|---|
| GSK1562902A M12 Group | Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 36 | 3.8 Fold change |
| GSK1562902A M12 Group | Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 42 | 2.8 Fold change |
| GSK1562902A M12 Group | Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 48 | 3.0 Fold change |
| GSK1562902A M12 Group | Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 36 | 1.3 Fold change |
| GSK1562902A M12 Group | Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 42 | 1.1 Fold change |
| GSK1562902A M12 Group | Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 48 | 1.2 Fold change |
| GSK1562902A M12 Group | Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 48 | 6.1 Fold change |
| GSK1562902A M12 Group | Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 42 | 6.0 Fold change |
| GSK1562902A M12 Group | Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 42 | 3.4 Fold change |
| GSK1562902A M12 Group | Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 36 | 4.5 Fold change |
| GSK1562902A M12 Group | Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 36 | 8.6 Fold change |
| GSK1562902A M12 Group | Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 48 | 3.7 Fold change |
| GSK1562902A M36 Group | Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 48 | 15.2 Fold change |
| GSK1562902A M36 Group | Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 48 | 24.0 Fold change |
Secondary
Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies
GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
Time frame: At Months 18, 24, 30
Population: The analysis was performed on the ATP cohort for persistence at Month 12-18 and at Month 24-30, which included all evaluable subjects not boosted and boosted at Month 12, not boosted at Month 12 but boosted at Month 6 or neither boosted at Month 6 nor at Month 12.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1562902A M12 Group | Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 18 | 8.4 Fold change |
| GSK1562902A M12 Group | Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 24 | 3.4 Fold change |
| GSK1562902A M12 Group | Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 30 | 3.4 Fold change |
| GSK1562902A M12 Group | Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 18 | 2.4 Fold change |
| GSK1562902A M12 Group | Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 24 | 1.7 Fold change |
| GSK1562902A M12 Group | Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 30 | 1.5 Fold change |
| GSK1562902A M12 Group | Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 24 | 6.1 Fold change |
| GSK1562902A M12 Group | Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 24 | 8.5 Fold change |
| GSK1562902A M12 Group | Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 30 | 4.8 Fold change |
| GSK1562902A M12 Group | Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 30 | 7.6 Fold change |
| GSK1562902A M36 Group | Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 18 | 1.9 Fold change |
| GSK1562902A M36 Group | Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 24 | 1.2 Fold change |
| GSK1562902A M36 Group | Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 24 | 1.9 Fold change |
| GSK1562902A M36 Group | Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 30 | 1.2 Fold change |
| GSK1562902A M36 Group | Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 30 | 1.9 Fold change |
| GSK1562902A M36 Group | Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 18 | 1.8 Fold change |
Secondary
Number of Seropositive Subjects for H5N1 HI Antibodies
Seropositivity was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:10 against the tested vaccine virus. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
Time frame: At Months 18, 24, 30 and 36
Population: The analysis was performed on the ATP cohort for persistence at Month 12-18 (M12-18) and at Month 24-30 (M24-30), which included all evaluable subjects not boosted (M12-18) and boosted (M24-30) at M12, not boosted at M12 but boosted at M6 or neither boosted at M6 nor at M12 (M24-30).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1562902A M12 Group | Number of Seropositive Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 18 | 178 Participants |
| GSK1562902A M12 Group | Number of Seropositive Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 24 | 142 Participants |
| GSK1562902A M12 Group | Number of Seropositive Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 30 | 144 Participants |
| GSK1562902A M12 Group | Number of Seropositive Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 36 | 144 Participants |
| GSK1562902A M12 Group | Number of Seropositive Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 18 | 176 Participants |
| GSK1562902A M12 Group | Number of Seropositive Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 24 | 161 Participants |
| GSK1562902A M12 Group | Number of Seropositive Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 30 | 154 Participants |
| GSK1562902A M12 Group | Number of Seropositive Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 36 | 149 Participants |
| GSK1562902A M12 Group | Number of Seropositive Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 30 | 149 Participants |
| GSK1562902A M12 Group | Number of Seropositive Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 30 | 158 Participants |
| GSK1562902A M12 Group | Number of Seropositive Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 36 | 147 Participants |
| GSK1562902A M12 Group | Number of Seropositive Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 18 | 0 Participants |
| GSK1562902A M12 Group | Number of Seropositive Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 24 | 154 Participants |
| GSK1562902A M12 Group | Number of Seropositive Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 18 | 0 Participants |
| GSK1562902A M12 Group | Number of Seropositive Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 24 | 147 Participants |
| GSK1562902A M12 Group | Number of Seropositive Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 36 | 152 Participants |
| GSK1562902A M36 Group | Number of Seropositive Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 30 | 73 Participants |
| GSK1562902A M36 Group | Number of Seropositive Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 24 | 58 Participants |
| GSK1562902A M36 Group | Number of Seropositive Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 18 | 146 Participants |
| GSK1562902A M36 Group | Number of Seropositive Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 36 | 0 Participants |
| GSK1562902A M36 Group | Number of Seropositive Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 30 | 168 Participants |
| GSK1562902A M36 Group | Number of Seropositive Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 24 | 187 Participants |
| GSK1562902A M36 Group | Number of Seropositive Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 18 | 173 Participants |
| GSK1562902A M36 Group | Number of Seropositive Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 36 | 0 Participants |
Secondary
Number of Seropositive Subjects for H5N1 HI Antibodies
Seropositivity was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:10 against the tested vaccine virus. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
Time frame: At Months 42 and 48
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1562902A M12 Group | Number of Seropositive Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 42 | 127 Participants |
| GSK1562902A M12 Group | Number of Seropositive Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 48 | 125 Participants |
| GSK1562902A M12 Group | Number of Seropositive Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 42 | 138 Participants |
| GSK1562902A M12 Group | Number of Seropositive Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 48 | 137 Participants |
| GSK1562902A M12 Group | Number of Seropositive Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 48 | 142 Participants |
| GSK1562902A M12 Group | Number of Seropositive Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 42 | 143 Participants |
| GSK1562902A M12 Group | Number of Seropositive Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 42 | 149 Participants |
| GSK1562902A M12 Group | Number of Seropositive Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 48 | 133 Participants |
| GSK1562902A M36 Group | Number of Seropositive Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 48 | 365 Participants |
| GSK1562902A M36 Group | Number of Seropositive Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 48 | 365 Participants |
| GSK1562902A M36 Group | Number of Seropositive Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 42 | 0 Participants |
| GSK1562902A M36 Group | Number of Seropositive Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 42 | 0 Participants |
Secondary
Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies
Seroprotection (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
Time frame: At Months 36, 42 and 48
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1562902A M12 Group | Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 42 | 79 Participants |
| GSK1562902A M12 Group | Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 42 | 70 Participants |
| GSK1562902A M12 Group | Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 48 | 88 Participants |
| GSK1562902A M12 Group | Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 48 | 76 Participants |
| GSK1562902A M12 Group | Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 36 | 90 Participants |
| GSK1562902A M12 Group | Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 36 | 104 Participants |
| GSK1562902A M12 Group | Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 36 | 126 Participants |
| GSK1562902A M12 Group | Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 42 | 110 Participants |
| GSK1562902A M12 Group | Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 36 | 121 Participants |
| GSK1562902A M12 Group | Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 48 | 104 Participants |
| GSK1562902A M12 Group | Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 48 | 114 Participants |
| GSK1562902A M12 Group | Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 42 | 101 Participants |
| GSK1562902A M36 Group | Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 48 | 349 Participants |
| GSK1562902A M36 Group | Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 36 | 0 Participants |
| GSK1562902A M36 Group | Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 42 | 0 Participants |
| GSK1562902A M36 Group | Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 36 | 0 Participants |
| GSK1562902A M36 Group | Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 42 | 0 Participants |
| GSK1562902A M36 Group | Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 48 | 351 Participants |
Secondary
Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies
Seroprotection (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
Time frame: At Months 18, 24 and 30
Population: The analysis was performed on the ATP cohort for persistence at Month 12-18 and at Month 24-30, which included all evaluable subjects not boosted and boosted at Month 12, not boosted at Month 12 but boosted at Month 6 or neither boosted at Month 6 nor at Month 12.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1562902A M12 Group | Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 18 | 157 Participants |
| GSK1562902A M12 Group | Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 24 | 88 Participants |
| GSK1562902A M12 Group | Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 30 | 95 Participants |
| GSK1562902A M12 Group | Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 18 | 149 Participants |
| GSK1562902A M12 Group | Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 24 | 115 Participants |
| GSK1562902A M12 Group | Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 30 | 107 Participants |
| GSK1562902A M12 Group | Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 30 | 128 Participants |
| GSK1562902A M12 Group | Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 18 | 0 Participants |
| GSK1562902A M12 Group | Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 18 | 0 Participants |
| GSK1562902A M12 Group | Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 24 | 135 Participants |
| GSK1562902A M12 Group | Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 24 | 117 Participants |
| GSK1562902A M12 Group | Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 30 | 120 Participants |
| GSK1562902A M36 Group | Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 24 | 10 Participants |
| GSK1562902A M36 Group | Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 30 | 16 Participants |
| GSK1562902A M36 Group | Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 30 | 88 Participants |
| GSK1562902A M36 Group | Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 18 | 79 Participants |
| GSK1562902A M36 Group | Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 18 | 75 Participants |
| GSK1562902A M36 Group | Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 24 | 67 Participants |
Secondary
Number of Subjects Boosted at Month 36 Seroconverted for H5N1 HI Antibodies
Seroconversion was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer \< 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
Time frame: At Months 18, 24 and 30
Population: The analysis was performed on the ATP cohort for persistence at Month 12-18 and at Month 24-30, which included all evaluable subjects not boosted and boosted at Month 12, not boosted at Month 12 but boosted at Month 6 or neither boosted at Month 6 nor at Month 12.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1562902A M12 Group | Number of Subjects Boosted at Month 36 Seroconverted for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 18 | 75 Participants |
| GSK1562902A M12 Group | Number of Subjects Boosted at Month 36 Seroconverted for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 24 | 6 Participants |
| GSK1562902A M12 Group | Number of Subjects Boosted at Month 36 Seroconverted for H5N1 HI Antibodies | A/Indonesia/05/2005, Month 30 | 14 Participants |
| GSK1562902A M12 Group | Number of Subjects Boosted at Month 36 Seroconverted for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 18 | 61 Participants |
| GSK1562902A M12 Group | Number of Subjects Boosted at Month 36 Seroconverted for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 24 | 43 Participants |
| GSK1562902A M12 Group | Number of Subjects Boosted at Month 36 Seroconverted for H5N1 HI Antibodies | A/Vietnam/1194/2004, Month 30 | 58 Participants |
Secondary
Number of Subjects With Adverse Events of Specific Interest (AESIs)
An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.
Time frame: During the entire study period (From Month 12 to Month 48)
Population: The analysis was performed on the Total Vaccinated cohort, which included all booster-vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1562902A M12 Group | Number of Subjects With Adverse Events of Specific Interest (AESIs) | 0 Participants |
| GSK1562902A M12 Group | Number of Subjects With Adverse Events of Specific Interest (AESIs) | 0 Participants |
| GSK1562902A M36 Group | Number of Subjects With Adverse Events of Specific Interest (AESIs) | 1 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/induration/redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time frame: During the 7-day (Days 0-6) post-vaccination period - subjects boosted at Month 12 and Month 36
Population: The analysis was performed on the Total Vaccinated cohort, which included all booster-vaccinated subjects for whom data were available and who had their symptom sheets filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1562902A M12 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Ecchymosis | 2 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Ecchymosis | 0 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Induration | 17 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Induration | 0 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 158 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 11 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 13 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 23 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Ecchymosis | 1 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 17 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Ecchymosis | 0 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Induration | 23 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 28 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Induration | 0 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 44 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 306 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptom
Assessed solicited general symptoms were arthralgia, fatigue, headache, myalgia, shivering, sweating and fever \[defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.
Time frame: During the 7-day (Days 0-6) post-vaccination period - subjects boosted at Month 12 and 36
Population: The analysis was performed on the Total Vaccinated cohort, which included all booster-vaccinated subjects for whom data were available and who has their symptom sheets filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Any Arthralgia | 48 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Grade 3 Arthralgia | 6 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Related Arthralgia | 45 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Any Fatigue | 112 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Grade 3 Fatigue | 12 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Related Fatigue | 105 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Any Headache | 76 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Grade 3 Headache | 12 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Related Headache | 69 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Any Myalgia | 123 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Grade 3 Myalgia | 14 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Related Myalgia | 119 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Any Shivering | 26 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Grade 3 Shivering | 3 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Related Shivering | 26 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Any Sweating | 22 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Grade 3 Sweating | 0 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Related Sweating | 20 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Any Temperature | 15 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Grade 3 Temperature | 1 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Related Temperature | 14 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Grade 3 Myalgia | 17 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Any Arthralgia | 99 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Any Temperature | 24 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Grade 3 Arthralgia | 7 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Related Myalgia | 226 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Related Arthralgia | 95 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Grade 3 Sweating | 2 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Any Fatigue | 216 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Any Shivering | 51 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Grade 3 Fatigue | 19 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Related Temperature | 23 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Related Fatigue | 213 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Grade 3 Shivering | 8 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Any Headache | 138 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Related Sweating | 52 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Grade 3 Headache | 7 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Related Shivering | 49 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Related Headache | 134 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Grade 3 Temperature | 3 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Any Myalgia | 235 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptom | Any Sweating | 54 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time frame: During the 30-day (Days 0-29) follow-up period after vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all booster-vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 44 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 6 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 22 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 85 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 9 Participants |
| GSK1562902A M12 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 34 Participants |
Secondary
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off
Seropositivity cut-off values assessed were equal to or above (≥) 1:28, ≥ 1:56 and ≥ 1:112 in the sera of subjects seronegative before vaccination. The flu strain assessed was A/Vietnam/1194/2004.
Time frame: At Months 6/12/36 + 21 days, 12, 24, 36 and 48
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 48, ≥ 1:28 | 73 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 12, ≥ 1:28 | 75 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 24, ≥ 1:28 | 74 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 36, ≥ 1:28 | 71 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 6, ≥ 1:28 | 162 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 6/12/36 + 21 days, ≥ 1:28 | 163 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 6, ≥ 1:56 | 158 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 12, ≥ 1:56 | 74 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 24, ≥ 1:56 | 60 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 36, ≥ 1:56 | 52 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 48, ≥ 1:56 | 65 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 6/12/36 + 21 days, ≥ 1:56 | 163 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 6, ≥ 1:112 | 134 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 12, ≥ 1:112 | 59 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 24, ≥ 1:112 | 34 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 36, ≥ 1:112 | 30 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 48, ≥ 1:112 | 30 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 6/12/36 + 21 days, ≥ 1:112 | 163 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 6/12/36 + 21 days, ≥ 1:112 | 170 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 6, ≥ 1:28 | 0 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 36, ≥ 1:56 | 60 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 6, ≥ 1:112 | 0 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 12, ≥ 1:28 | 162 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 24, ≥ 1:112 | 50 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 36, ≥ 1:112 | 43 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 24, ≥ 1:28 | 75 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 48, ≥ 1:56 | 65 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 48, ≥ 1:112 | 48 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 36, ≥ 1:28 | 73 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 24, ≥ 1:56 | 71 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 12, ≥ 1:112 | 137 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 48, ≥ 1:28 | 74 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 12, ≥ 1:56 | 155 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 6/12/36 + 21 days, ≥ 1:56 | 170 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 6/12/36 + 21 days, ≥ 1:28 | 170 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 6, ≥ 1:56 | 0 Participants |
| GSK1562902A M36 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 6/12/36 + 21 days, ≥ 1:28 | 74 Participants |
| GSK1562902A M36 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 6, ≥ 1:56 | 0 Participants |
| GSK1562902A M36 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 12, ≥ 1:56 | 0 Participants |
| GSK1562902A M36 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 24, ≥ 1:112 | 6 Participants |
| GSK1562902A M36 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 24, ≥ 1:56 | 29 Participants |
| GSK1562902A M36 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 6/12/36 + 21 days, ≥ 1:112 | 72 Participants |
| GSK1562902A M36 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 36, ≥ 1:56 | 27 Participants |
| GSK1562902A M36 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 48, ≥ 1:56 | 74 Participants |
| GSK1562902A M36 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 36, ≥ 1:112 | 5 Participants |
| GSK1562902A M36 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 6/12/36 + 21 days, ≥ 1:56 | 74 Participants |
| GSK1562902A M36 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 6, ≥ 1:28 | 0 Participants |
| GSK1562902A M36 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 12, ≥ 1:28 | 0 Participants |
| GSK1562902A M36 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 6, ≥ 1:112 | 0 Participants |
| GSK1562902A M36 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 24, ≥ 1:28 | 58 Participants |
| GSK1562902A M36 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 36, ≥ 1:28 | 55 Participants |
| GSK1562902A M36 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 48, ≥ 1:28 | 74 Participants |
| GSK1562902A M36 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 12, ≥ 1:112 | 0 Participants |
| GSK1562902A M36 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off | Month 48, ≥ 1:112 | 68 Participants |
Secondary
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
Seropositivity cut-off values assessed were equal to or above (≥) 1:28, ≥ 1:56 and ≥ 1:112 in the sera of subjects seronegative before vaccination. The flu strain assessed was A/Indonesia/05/2005.
Time frame: At Months 6/12/36 + 21 days, 12, 24, 36 and 48
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 48, ≥ 1:28 | 67 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 12, ≥ 1:28 | 74 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 24, ≥ 1:28 | 70 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 36, ≥ 1:28 | 66 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 6, ≥ 1:28 | 160 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 6/12/36 + 21 days, ≥ 1:28 | 162 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 6, ≥ 1:56 | 153 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 12, ≥ 1:56 | 70 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 24, ≥ 1:56 | 54 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 36, ≥ 1:56 | 48 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 48, ≥ 1:56 | 51 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 6/12/36 + 21 days, ≥ 1:56 | 162 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 6, ≥ 1:112 | 140 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 12, ≥ 1:112 | 50 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 24, ≥ 1:112 | 26 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 36, ≥ 1:112 | 24 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 48, ≥ 1:112 | 23 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 6/12/36 + 21 days, ≥ 1:112 | 161 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 6/12/36 + 21 days, ≥ 1:112 | 170 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 6, ≥ 1:28 | 0 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 36, ≥ 1:56 | 58 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 6, ≥ 1:112 | 0 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 12, ≥ 1:28 | 135 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 24, ≥ 1:112 | 47 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 36, ≥ 1:112 | 41 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 24, ≥ 1:28 | 72 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 48, ≥ 1:56 | 58 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 48, ≥ 1:112 | 39 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 36, ≥ 1:28 | 69 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 24, ≥ 1:56 | 67 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 12, ≥ 1:112 | 45 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 48, ≥ 1:28 | 73 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 12, ≥ 1:56 | 99 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 6/12/36 + 21 days, ≥ 1:56 | 170 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 6/12/36 + 21 days, ≥ 1:28 | 170 Participants |
| GSK1562902A M12 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 6, ≥ 1:56 | 0 Participants |
| GSK1562902A M36 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 6/12/36 + 21 days, ≥ 1:28 | 75 Participants |
| GSK1562902A M36 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 6, ≥ 1:56 | 0 Participants |
| GSK1562902A M36 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 12, ≥ 1:56 | 0 Participants |
| GSK1562902A M36 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 24, ≥ 1:112 | 0 Participants |
| GSK1562902A M36 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 24, ≥ 1:56 | 2 Participants |
| GSK1562902A M36 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 6/12/36 + 21 days, ≥ 1:112 | 71 Participants |
| GSK1562902A M36 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 36, ≥ 1:56 | 4 Participants |
| GSK1562902A M36 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 48, ≥ 1:56 | 72 Participants |
| GSK1562902A M36 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 36, ≥ 1:112 | 0 Participants |
| GSK1562902A M36 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 6/12/36 + 21 days, ≥ 1:56 | 74 Participants |
| GSK1562902A M36 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 6, ≥ 1:28 | 0 Participants |
| GSK1562902A M36 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 12, ≥ 1:28 | 0 Participants |
| GSK1562902A M36 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 6, ≥ 1:112 | 0 Participants |
| GSK1562902A M36 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 24, ≥ 1:28 | 17 Participants |
| GSK1562902A M36 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 36, ≥ 1:28 | 19 Participants |
| GSK1562902A M36 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 48, ≥ 1:28 | 74 Participants |
| GSK1562902A M36 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 12, ≥ 1:112 | 0 Participants |
| GSK1562902A M36 Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | Month 48, ≥ 1:112 | 65 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: During the entire study period (From Month 12 up to Month 48)
Population: The analysis was performed on the Total Vaccinated cohort, which included all booster-vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1562902A M12 Group | Number of Subjects With Serious Adverse Events (SAEs) | Month 12 to Month 48 | 14 Participants |
| GSK1562902A M12 Group | Number of Subjects With Serious Adverse Events (SAEs) | Month 42 to Month 48 | 2 Participants |
| GSK1562902A M12 Group | Number of Subjects With Serious Adverse Events (SAEs) | Month 12 to Month 48 | 13 Participants |
| GSK1562902A M12 Group | Number of Subjects With Serious Adverse Events (SAEs) | Month 42 to Month 48 | 3 Participants |
| GSK1562902A M36 Group | Number of Subjects With Serious Adverse Events (SAEs) | Month 12 to Month 48 | 28 Participants |
| GSK1562902A M36 Group | Number of Subjects With Serious Adverse Events (SAEs) | Month 42 to Month 48 | 4 Participants |
Secondary
Titers for Serum Neutralizing Antibodies
Titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:28. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
Time frame: At Months 6/12, 6/12 + 21 days, 24, 36 and 48
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. This included 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) |
|---|---|---|---|
| GSK1562902A M12 Group | Titers for Serum Neutralizing Antibodies | A/Indonesia/05/2005, Month 48 | 54.5 Titers |
| GSK1562902A M12 Group | Titers for Serum Neutralizing Antibodies | A/Indonesia/05/2005, Month 6/12/36 + 21 days | 2702.0 Titers |
| GSK1562902A M12 Group | Titers for Serum Neutralizing Antibodies | A/Indonesia/05/2005, Month 12 | 134.0 Titers |
| GSK1562902A M12 Group | Titers for Serum Neutralizing Antibodies | A/Indonesia/05/2005, Month 24 | 66.3 Titers |
| GSK1562902A M12 Group | Titers for Serum Neutralizing Antibodies | A/Indonesia/05/2005, Month 36 | 55.4 Titers |
| GSK1562902A M12 Group | Titers for Serum Neutralizing Antibodies | A/Vietnam/1194/2004, Month 6 | 169.9 Titers |
| GSK1562902A M12 Group | Titers for Serum Neutralizing Antibodies | A/Vietnam/1194/2004, Month 6/12/36 + 21 days | 1566.3 Titers |
| GSK1562902A M12 Group | Titers for Serum Neutralizing Antibodies | A/Vietnam/1194/2004, Month 12 | 159.4 Titers |
| GSK1562902A M12 Group | Titers for Serum Neutralizing Antibodies | A/Vietnam/1194/2004, Month 24 | 74.0 Titers |
| GSK1562902A M12 Group | Titers for Serum Neutralizing Antibodies | A/Vietnam/1194/2004, Month 36 | 62.0 Titers |
| GSK1562902A M12 Group | Titers for Serum Neutralizing Antibodies | A/Vietnam/1194/2004, Month 48 | 71.4 Titers |
| GSK1562902A M12 Group | Titers for Serum Neutralizing Antibodies | A/Indonesia/05/2005, Month 6 | 179.7 Titers |
| GSK1562902A M12 Group | Titers for Serum Neutralizing Antibodies | A/Vietnam/1194/2004, Month 48 | 117.4 Titers |
| GSK1562902A M12 Group | Titers for Serum Neutralizing Antibodies | A/Indonesia/05/2005, Month 12 | 58.5 Titers |
| GSK1562902A M12 Group | Titers for Serum Neutralizing Antibodies | A/Vietnam/1194/2004, Month 24 | 164.9 Titers |
| GSK1562902A M12 Group | Titers for Serum Neutralizing Antibodies | A/Indonesia/05/2005, Month 24 | 148.9 Titers |
| GSK1562902A M12 Group | Titers for Serum Neutralizing Antibodies | A/Vietnam/1194/2004, Month 36 | 121.1 Titers |
| GSK1562902A M12 Group | Titers for Serum Neutralizing Antibodies | A/Vietnam/1194/2004, Month 12 | 204.1 Titers |
| GSK1562902A M12 Group | Titers for Serum Neutralizing Antibodies | A/Indonesia/05/2005, Month 36 | 106.9 Titers |
| GSK1562902A M12 Group | Titers for Serum Neutralizing Antibodies | A/Indonesia/05/2005, Month 48 | 103.4 Titers |
| GSK1562902A M12 Group | Titers for Serum Neutralizing Antibodies | A/Indonesia/05/2005, Month 6/12/36 + 21 days | 2363.2 Titers |
| GSK1562902A M12 Group | Titers for Serum Neutralizing Antibodies | A/Vietnam/1194/2004, Month 6/12/36 + 21 days | 2734.9 Titers |
| GSK1562902A M36 Group | Titers for Serum Neutralizing Antibodies | A/Indonesia/05/2005, Month 36 | 17.3 Titers |
| GSK1562902A M36 Group | Titers for Serum Neutralizing Antibodies | A/Indonesia/05/2005, Month 48 | 320.4 Titers |
| GSK1562902A M36 Group | Titers for Serum Neutralizing Antibodies | A/Vietnam/1194/2004, Month 6/12/36 + 21 days | 1373.4 Titers |
| GSK1562902A M36 Group | Titers for Serum Neutralizing Antibodies | A/Vietnam/1194/2004, Month 36 | 31.8 Titers |
| GSK1562902A M36 Group | Titers for Serum Neutralizing Antibodies | A/Indonesia/05/2005, Month 6/12/36 + 21 days | 1154.3 Titers |
| GSK1562902A M36 Group | Titers for Serum Neutralizing Antibodies | A/Vietnam/1194/2004, Month 48 | 429.0 Titers |
| GSK1562902A M36 Group | Titers for Serum Neutralizing Antibodies | A/Indonesia/05/2005, Month 24 | 16.7 Titers |
| GSK1562902A M36 Group | Titers for Serum Neutralizing Antibodies | A/Vietnam/1194/2004, Month 24 | 33.3 Titers |