Influenza
Conditions
Keywords
H5N1, influenza infection, Influenza vaccine GSK1562902A
Brief summary
The objective of the study is to evaluate the immunogenicity and safety of prime-boost vaccination schedule of GSK Biologicals' investigational vaccine GSK1562902A.
Detailed description
This protocol posting was modified according to the protocol amendment 2 (dated 16-June-2011). The impacted section is eligibility criteria.
Interventions
BIOLOGICALGSK Biologicals' investigational vaccine GSK1562902A
Three intramuscular injections
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Subjects were to be stratified into three age strata (6 to 11 months, 12 to 23 months and 24 to 35 months) in the ratio of 2:1:1.
Eligibility
Sex/Gender
ALL
Age
6 Months to 35 Months
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that parents/Legally Acceptable Representatives (LARs) can and will comply with the requirements of the protocol. * Children, male or female between, and including, 6 and 35 months of age at the time of first study vaccination. * Written informed consent obtained from the parent(s)/LAR(s) of the subject. * Healthy children as established by medical history and clinical examination before entering the study. * Parent/LAR access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device. * Subjects who are likely to reside in the vicinity of the study centre for the duration of the study. In studies using the home-based model for vaccination and follow-up, subjects who are likely to remain in the vicinity of the area where they were recruited.
Exclusion criteria
* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * Planned administration of any vaccine 30 days prior and 21 days after any study vaccine administration. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines such as egg protein or thiomersal. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * History of any neurological disorders or seizures. * Acute disease at the time of enrolment. * Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests. * Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned administration during the study period. * Any condition which, in the opinion of the investigator, renders the subject unfit for participation in the study. * Child in care. * Previous vaccination at any time with an H5N1 vaccine. * Medical history of physician-confirmed infection with a H5N1 virus.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroconverted Subjects in Terms of H5N1 Hemagglutination Inhibition (HI) Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | At Day 192 | A seroconverted subject is defined as a subject that had either a pre-vaccination (Day 0) titer \< 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer on Day 192. |
| Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain | At Day 192 | Mean Geometric Change is defined as the geometric mean of the within-subject ratios of the post vaccination (Day 192) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer (i.e. post-vaccination divided by pre-vaccination titer). |
| Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain | At Day 192 | A seroprotected subject is defined as a subject with a serum H5N1 HI antibody titer ≥1:40. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | At Day 0, Day 182, Day 192 and Day 364 | A seropositive subject is defined as a subject with a serum H5N1 HI antibody titer ≥ 1:10. |
| Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | At Day 42, Day 182, Day 192 and Day 364 | A seroconverted subjects is defined as a subject who had either a pre vaccination (Day 0) titer \<1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a 4-fold increase in post-vaccination titer. |
| Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | At Day 182 and Day 364 | A seroconverted subjects is defined as a subject who had either a pre vaccination (Day 0) titer \<1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a 4-fold increase in post-vaccination titer. Data for Day 192 are presented under Primary Outcome Measures. |
| Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 Virus Strain | At Day 0, Day 42, Day 182, Day 192 and Day 364 | A seroprotected subject is defined as a subject with a serum H5N1 HI antibody titer ≥1:40. |
| Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Day 0, Day 182 and Day 364 | A seroprotected subject is defined as a subject with a serum H5N1 HI antibody titer ≥1:40. Data for Day 192 are presented under Primary Outcome Measures. |
| Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | At Day 42, Day 182, Day 192 and Day 364 | Mean Geometric Change is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer (i.e. post-vaccination divided by pre-vaccination titer). |
| Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain | Day 182 and Day 364 | Mean Geometric Change is defined as the geometric mean of the within-subject ratios of the post vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer (i.e. post-vaccination divided by pre-vaccination titer). Data for Day 192 are presented under Primary Outcome Measures. |
| Number of Booster Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | At Day 192 and Day 364 | Booster seroconversion is defined as follows: For seronegative subjects at pre-booster (Day 182), antibody titer ≥1:40 at post-booster time point(s). For seropositive subjects at pre-booster (Day 182), antibody titer at post-booster time point(s) ≥4-fold the pre-booster antibody titer. |
| Booster Factor in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | At Day 192 and Day 364 | Booster Factor was defined as the geometric mean of the within-subject ratios of the post-booster vaccination reciprocal HI titer to the pre-booster (Day 182) reciprocal titer. |
| Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Day 0, Day 42, Day 182, Day 192 and Day 364 | A seropositive subject is defined as a subject with serum neutralizing antibody titers ≥ 1:28 |
| Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Day 0, Day 182, Day 192 and Day 364 | A seropositive subject is defined as a subject with serum neutralizing antibody titers ≥ 1:28. |
| Hemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/05/2005 H5N1 Virus Strain | At Day 0, Day 42, Day 182, Day 192 and Day 364 | Titers were presented as geometric mean titers (GMTs). Analyses were done by age stratum and overall. |
| Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Day 0, Day 182, Day 192 and Day 364 | Titers were presented as geometric mean titers (GMTs). |
| Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | At Day 42, Day 182, Day 192 and Day 364 | Vaccine response is defined as: For initially seronegative subjects, neutralizing antibody titer ≥ 1:56 at the considered time point after vaccination For initially seropositive subjects, neutralizing antibody titer ≥ 4 fold from pre-vaccination (Day 0) |
| Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | At Day 182, Day 192 and Day 364 | Vaccine response is defined as: For initially seronegative subjects, neutralizing antibody titer ≥ 1:56 at the considered time point after vaccination For initially seropositive subjects, neutralizing antibody titer ≥ 4 fold from pre-vaccination (Day 0) |
| Number of Subjects With a Booster Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | At Day 192 and Day 364 | Booster vaccine response is defined as: For seronegative subjects at Day 182, neutralizing antibody titers ≥ 1:56 at the considered time point after vaccination For seropositive subjects at Day 182, neutralizing antibody titers ≥ 4 fold from pre-vaccination (Day 182) |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 7-day post-vaccination period following each dose and across doses (Day 0 - Day 7, Day 21 - Day 28, Day 182 - Day 189) | Solicited local symptoms assigned were pain, swelling and redness. Any was defined as occurrence of any local symptom regardless of intensity grade; Grade 3 pain was defined as cried when limb was moved spontaneously painful. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 7-day post-vaccination period following each dose and across doses (Day 0 - Day 7, Day 21 - Day 28, Day 182 - Day 189) | Solicited general symptoms assessed were diarrhoea/ vomiting, drowsiness, irritability/ fussiness, loss of appetite, fever (axillary). Any= occurrence of any general symptom regardless of intensity grade and relationship to the vaccine. Irritability/ fussiness grade 3=crying that could not be comforted/ prevented normal activity; Drowsiness grade 3= drowsiness that prevented normal activity; Loss of appetite grade 3= did not eat at all; Diarrhoea/ vomiting grade 3= diarrhoea/ vomiting that prevented normal activity; Related= general symptom assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects With Medically-attended Events (MAEs) | During the entire study period (from Day 0 to Day 364) | MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed. |
| Number of Subjects With Potential Immune-mediated Disease (pIMDs) | During the entire study period (from day 0 to Day 364) | Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. |
| Number of Subjects With Unsolicited Adverse Events (AEs) | During a 21 day follow-up period after each vaccination (Day 0 - Day 21, Day 21 - Day 42, Day 182 - Day 203) | An AE is 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. Any was defined as an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. Grade 3 was defined as an AE which prevented normal, everyday activities. Related was defined as an AE assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs) | During the entire study period (from Day 0 to 364) | Serious adverse events (SAEs) assessed included medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity. |
| Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Day 0, Day 42, Day 182, Day 192 and Day 364 | Titers were presented as geometric mean titers (GMTs). |
| Hemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/01/2005 H5N1 Virus Strain | At Day 0, Day 182, Day 192 and Day 364 | Titers were presented as geometric mean titers (GMTs). Analyses were done by age stratum and overall. |
| Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 | At Day 0, Day 42, Day 182, Day 192 and Day 364 | A seropositive subject is defined as a subject with a serum H5N1 HI antibody titer ≥ 1:10. |
Countries
Australia, Singapore
Participant flow
Pre-assignment details
During the screening the following steps occurred: check for inclusion/ exclusion criteria, contraindications/ precautions, medical history of the subjects and signing informed consent forms.
Participants by arm
| Arm | Count |
|---|---|
| GSK1562902A 6 to 12 M Group Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182. | 46 |
| GSK1562902A 12 to 24 M Group Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182. | 34 |
| GSK1562902A 24 to 36 M Group Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182. | 33 |
| Total | 113 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
| Overall Study | Parents refused the last blood draw | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 2 | 0 |
Baseline characteristics
| Characteristic | GSK1562902A 6 to 12 M Group | GSK1562902A 12 to 24 M Group | GSK1562902A 24 to 36 M Group | Total |
|---|---|---|---|---|
| Age, Continuous | 8.3 Months STANDARD_DEVIATION 1.56 | 16.1 Months STANDARD_DEVIATION 3.44 | 29.6 Months STANDARD_DEVIATION 3.38 | 16.87 Months STANDARD_DEVIATION 9.26 |
| Race/Ethnicity, Customized Asian - east asian heritage | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian -South East Asian heritage, n(%) | 33 Participants | 25 Participants | 22 Participants | 80 Participants |
| Race/Ethnicity, Customized Unspecified | 1 Participants | 0 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized White - caucasian / european heritage | 12 Participants | 8 Participants | 9 Participants | 29 Participants |
| Sex: Female, Male Female | 25 Participants | 19 Participants | 19 Participants | 63 Participants |
| Sex: Female, Male Male | 21 Participants | 15 Participants | 14 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 34 | 0 / 33 |
| other Total, other adverse events | 45 / 46 | 32 / 34 | 33 / 33 |
| serious Total, serious adverse events | 5 / 46 | 4 / 34 | 0 / 33 |
Outcome results
Primary
Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain
Mean Geometric Change is defined as the geometric mean of the within-subject ratios of the post vaccination (Day 192) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer (i.e. post-vaccination divided by pre-vaccination titer).
Time frame: At Day 192
Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6, including all evaluable subjects for whom considered assay results were available for pre-vaccination (Day 0) and post-vaccination (Day 192) time points. Analyses were done by age stratum and overall.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK1562902A 6 to 12 M Group | Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain | 424.1 Titers |
| GSK1562902A 12 to 24 M Group | Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain | 317.6 Titers |
| GSK1562902A 24 to 36 M Group | Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain | 321.2 Titers |
| GSK1562902A Group | Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain | 357.7 Titers |
Primary
Number of Seroconverted Subjects in Terms of H5N1 Hemagglutination Inhibition (HI) Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
A seroconverted subject is defined as a subject that had either a pre-vaccination (Day 0) titer \< 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer on Day 192.
Time frame: At Day 192
Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6, including all evaluable subjects for whom considered assay results were available for pre-vaccination (Day 0) and post-vaccination (Day 192) time points. Analyses were done by age stratum and overall.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1562902A 6 to 12 M Group | Number of Seroconverted Subjects in Terms of H5N1 Hemagglutination Inhibition (HI) Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | 33 Participants |
| GSK1562902A 12 to 24 M Group | Number of Seroconverted Subjects in Terms of H5N1 Hemagglutination Inhibition (HI) Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | 21 Participants |
| GSK1562902A 24 to 36 M Group | Number of Seroconverted Subjects in Terms of H5N1 Hemagglutination Inhibition (HI) Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | 29 Participants |
| GSK1562902A Group | Number of Seroconverted Subjects in Terms of H5N1 Hemagglutination Inhibition (HI) Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | 83 Participants |
Primary
Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain
A seroprotected subject is defined as a subject with a serum H5N1 HI antibody titer ≥1:40.
Time frame: At Day 192
Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6, including all evaluable subjects for whom considered assay results were available for pre-vaccination (Day 0) and post-vaccination (Day 192) time points. Analyses were done by age stratum and overall.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1562902A 6 to 12 M Group | Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain | 33 Participants |
| GSK1562902A 12 to 24 M Group | Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain | 21 Participants |
| GSK1562902A 24 to 36 M Group | Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain | 29 Participants |
| GSK1562902A Group | Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain | 83 Participants |
Secondary
Booster Factor in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Booster Factor was defined as the geometric mean of the within-subject ratios of the post-booster vaccination reciprocal HI titer to the pre-booster (Day 182) reciprocal titer.
Time frame: At Day 192 and Day 364
Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the pre-booster vaccination time point (Day 182) and the considered time point. Analyses were done by age stratum and overall.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1562902A 6 to 12 M Group | Booster Factor in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005 H5N1.HA [Day 192] | 25.7 Titer |
| GSK1562902A 6 to 12 M Group | Booster Factor in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005 H5N1.HA [Day 364] | 19.9 Titer |
| GSK1562902A 12 to 24 M Group | Booster Factor in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005 H5N1.HA [Day 364] | 16.4 Titer |
| GSK1562902A 12 to 24 M Group | Booster Factor in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005 H5N1.HA [Day 192] | 21.5 Titer |
| GSK1562902A 24 to 36 M Group | Booster Factor in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005 H5N1.HA [Day 192] | 20.5 Titer |
| GSK1562902A 24 to 36 M Group | Booster Factor in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005 H5N1.HA [Day 364] | 9.5 Titer |
| GSK1562902A Group | Booster Factor in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005 H5N1.HA [Day 192] | 22.7 Titer |
| GSK1562902A Group | Booster Factor in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005 H5N1.HA [Day 364] | 14.9 Titer |
Secondary
Hemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/05/2005 H5N1 Virus Strain
Titers were presented as geometric mean titers (GMTs). Analyses were done by age stratum and overall.
Time frame: At Day 0, Day 42, Day 182, Day 192 and Day 364
Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 0, 42, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the considered time point. Analyses were done by age stratum and overall.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1562902A 6 to 12 M Group | Hemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005.HA [Day 192] | 2163.9 Titer |
| GSK1562902A 6 to 12 M Group | Hemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005.HA [Day 42] | 945.2 Titer |
| GSK1562902A 6 to 12 M Group | Hemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005.HA [Day 364] | 1465.4 Titer |
| GSK1562902A 6 to 12 M Group | Hemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005.HA [Day 182] | 160.0 Titer |
| GSK1562902A 6 to 12 M Group | Hemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005.HA [Day 0] | NA Titer |
| GSK1562902A 12 to 24 M Group | Hemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005.HA [Day 182] | 147.3 Titer |
| GSK1562902A 12 to 24 M Group | Hemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005.HA [Day 192] | 1534.7 Titer |
| GSK1562902A 12 to 24 M Group | Hemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005.HA [Day 364] | 1055.8 Titer |
| GSK1562902A 12 to 24 M Group | Hemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005.HA [Day 42] | 1336.7 Titer |
| GSK1562902A 12 to 24 M Group | Hemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005.HA [Day 0] | NA Titer |
| GSK1562902A 24 to 36 M Group | Hemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005.HA [Day 182] | 133.7 Titer |
| GSK1562902A 24 to 36 M Group | Hemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005.HA [Day 0] | NA Titer |
| GSK1562902A 24 to 36 M Group | Hemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005.HA [Day 42] | 1044.7 Titer |
| GSK1562902A 24 to 36 M Group | Hemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005.HA [Day 192] | 1606.2 Titer |
| GSK1562902A 24 to 36 M Group | Hemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005.HA [Day 364] | 668.4 Titer |
| GSK1562902A Group | Hemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005.HA [Day 192] | 1787.6 Titer |
| GSK1562902A Group | Hemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005.HA [Day 42] | 1078.6 Titer |
| GSK1562902A Group | Hemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005.HA [Day 0] | NA Titer |
| GSK1562902A Group | Hemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005.HA [Day 182] | 147.2 Titer |
| GSK1562902A Group | Hemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005.HA [Day 364] | 1043.3 Titer |
Secondary
Hemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/01/2005 H5N1 Virus Strain
Titers were presented as geometric mean titers (GMTs). Analyses were done by age stratum and overall.
Time frame: At Day 0, Day 182, Day 192 and Day 364
Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 0, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the considered time point. Analyses were done by age stratum and overall.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1562902A 6 to 12 M Group | Hemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/01/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005.HA [Day 0] | 5.8 Titer |
| GSK1562902A 6 to 12 M Group | Hemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/01/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005.HA [Day 182] | 95.7 Titer |
| GSK1562902A 6 to 12 M Group | Hemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/01/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005.HA [Day 192] | 2454.6 Titer |
| GSK1562902A 6 to 12 M Group | Hemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/01/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005.HA [Day 364] | 1810.1 Titer |
| GSK1562902A 12 to 24 M Group | Hemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/01/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005.HA [Day 182] | 84.1 Titer |
| GSK1562902A 12 to 24 M Group | Hemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/01/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005.HA [Day 192] | 1810.2 Titer |
| GSK1562902A 12 to 24 M Group | Hemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/01/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005.HA [Day 364] | 1263.8 Titer |
| GSK1562902A 12 to 24 M Group | Hemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/01/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005.HA [Day 0] | 5.8 Titer |
| GSK1562902A 24 to 36 M Group | Hemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/01/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005.HA [Day 192] | 1767.4 Titer |
| GSK1562902A 24 to 36 M Group | Hemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/01/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005.HA [Day 182] | 86.1 Titer |
| GSK1562902A 24 to 36 M Group | Hemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/01/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005.HA [Day 364] | 803.4 Titer |
| GSK1562902A 24 to 36 M Group | Hemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/01/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005.HA [Day 0] | 5.5 Titer |
| GSK1562902A Group | Hemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/01/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005.HA [Day 364] | 1266.8 Titer |
| GSK1562902A Group | Hemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/01/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005.HA [Day 182] | 89.3 Titer |
| GSK1562902A Group | Hemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/01/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005.HA [Day 0] | 5.7 Titer |
| GSK1562902A Group | Hemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/01/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005.HA [Day 192] | 2026.2 Titer |
Secondary
Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
Mean Geometric Change is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer (i.e. post-vaccination divided by pre-vaccination titer).
Time frame: At Day 42, Day 182, Day 192 and Day 364
Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 42, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the pre-vaccination time point (Day 0) and the considered time point. Analyses were done by age stratum and overall.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1562902A 6 to 12 M Group | Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005 H5N1.HA [Day 42] | 189.0 Titer |
| GSK1562902A 6 to 12 M Group | Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005 H5N1.HA [Day 182] | 32.0 Titer |
| GSK1562902A 6 to 12 M Group | Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005 H5N1.HA [Day 192] | 432.8 Titer |
| GSK1562902A 6 to 12 M Group | Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005 H5N1.HA [Day 364] | 293.1 Titer |
| GSK1562902A 12 to 24 M Group | Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005 H5N1.HA [Day 182] | 29.5 Titer |
| GSK1562902A 12 to 24 M Group | Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005 H5N1.HA [Day 192] | 306.9 Titer |
| GSK1562902A 12 to 24 M Group | Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005 H5N1.HA [Day 364] | 211.2 Titer |
| GSK1562902A 12 to 24 M Group | Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005 H5N1.HA [Day 42] | 267.3 Titer |
| GSK1562902A 24 to 36 M Group | Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005 H5N1.HA [Day 192] | 321.2 Titer |
| GSK1562902A 24 to 36 M Group | Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005 H5N1.HA [Day 182] | 26.7 Titer |
| GSK1562902A 24 to 36 M Group | Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005 H5N1.HA [Day 364] | 133.7 Titer |
| GSK1562902A 24 to 36 M Group | Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005 H5N1.HA [Day 42] | 208.9 Titer |
| GSK1562902A Group | Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005 H5N1.HA [Day 364] | 208.7 Titer |
| GSK1562902A Group | Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005 H5N1.HA [Day 182] | 29.4 Titer |
| GSK1562902A Group | Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005 H5N1.HA [Day 42] | 215.7 Titer |
| GSK1562902A Group | Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005 H5N1.HA [Day 192] | 357.5 Titer |
Secondary
Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain
Mean Geometric Change is defined as the geometric mean of the within-subject ratios of the post vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer (i.e. post-vaccination divided by pre-vaccination titer). Data for Day 192 are presented under Primary Outcome Measures.
Time frame: Day 182 and Day 364
Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 182) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the pre-vaccination time point (Day 0) and the considered time point. Analyses were done by age stratum and overall.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1562902A 6 to 12 M Group | Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain | A/turkey/Turkey/1/2005 H5N1.HA [Day 364] | 19.9 Titer |
| GSK1562902A 6 to 12 M Group | Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain | A/turkey/Turkey/1/2005 H5N1.HA [Day 182] | 16.5 Titer |
| GSK1562902A 12 to 24 M Group | Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain | A/turkey/Turkey/1/2005 H5N1.HA [Day 364] | 16.4 Titer |
| GSK1562902A 12 to 24 M Group | Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain | A/turkey/Turkey/1/2005 H5N1.HA [Day 182] | 14.8 Titer |
| GSK1562902A 24 to 36 M Group | Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain | A/turkey/Turkey/1/2005 H5N1.HA [Day 182] | 15.6 Titer |
| GSK1562902A 24 to 36 M Group | Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain | A/turkey/Turkey/1/2005 H5N1.HA [Day 364] | 9.5 Titer |
| GSK1562902A Group | Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain | A/turkey/Turkey/1/2005 H5N1.HA [Day 182] | 15.8 Titer |
| GSK1562902A Group | Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain | A/turkey/Turkey/1/2005 H5N1.HA [Day 364] | 14.9 Titer |
Secondary
Number of Booster Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Booster seroconversion is defined as follows: For seronegative subjects at pre-booster (Day 182), antibody titer ≥1:40 at post-booster time point(s). For seropositive subjects at pre-booster (Day 182), antibody titer at post-booster time point(s) ≥4-fold the pre-booster antibody titer.
Time frame: At Day 192 and Day 364
Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the pre-booster vaccination time point (Day 182) and the considered time point. Analyses were done by age stratum and overall.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1562902A 6 to 12 M Group | Number of Booster Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005 H5N1.HA [Day 192] | 32 Participants |
| GSK1562902A 6 to 12 M Group | Number of Booster Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005 H5N1.HA [Day 364] | 41 Participants |
| GSK1562902A 12 to 24 M Group | Number of Booster Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005 H5N1.HA [Day 364] | 26 Participants |
| GSK1562902A 12 to 24 M Group | Number of Booster Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005 H5N1.HA [Day 192] | 21 Participants |
| GSK1562902A 24 to 36 M Group | Number of Booster Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005 H5N1.HA [Day 192] | 29 Participants |
| GSK1562902A 24 to 36 M Group | Number of Booster Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005 H5N1.HA [Day 364] | 28 Participants |
| GSK1562902A Group | Number of Booster Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005 H5N1.HA [Day 192] | 82 Participants |
| GSK1562902A Group | Number of Booster Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005 H5N1.HA [Day 364] | 95 Participants |
Secondary
Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
A seroconverted subjects is defined as a subject who had either a pre vaccination (Day 0) titer \<1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a 4-fold increase in post-vaccination titer.
Time frame: At Day 42, Day 182, Day 192 and Day 364
Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 42, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the pre-vaccination time point (Day 0) and the considered time point. Analyses were done by age stratum and overall.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1562902A 6 to 12 M Group | Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005.HA [Day 182] | 32 Participants |
| GSK1562902A 6 to 12 M Group | Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005.HA [Day 42] | 32 Participants |
| GSK1562902A 6 to 12 M Group | Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005.HA [Day 192] | 33 Participants |
| GSK1562902A 6 to 12 M Group | Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005.HA [Day 364] | 41 Participants |
| GSK1562902A 12 to 24 M Group | Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005.HA [Day 182] | 21 Participants |
| GSK1562902A 12 to 24 M Group | Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005.HA [Day 192] | 21 Participants |
| GSK1562902A 12 to 24 M Group | Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005.HA [Day 42] | 24 Participants |
| GSK1562902A 12 to 24 M Group | Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005.HA [Day 364] | 27 Participants |
| GSK1562902A 24 to 36 M Group | Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005.HA [Day 42] | 29 Participants |
| GSK1562902A 24 to 36 M Group | Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005.HA [Day 182] | 29 Participants |
| GSK1562902A 24 to 36 M Group | Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005.HA [Day 364] | 32 Participants |
| GSK1562902A 24 to 36 M Group | Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005.HA [Day 192] | 29 Participants |
| GSK1562902A Group | Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005.HA [Day 364] | 100 Participants |
| GSK1562902A Group | Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005.HA [Day 192] | 83 Participants |
| GSK1562902A Group | Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005.HA [Day 182] | 82 Participants |
| GSK1562902A Group | Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | A/Indonesia/05/2005.HA [Day 42] | 85 Participants |
Secondary
Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
A seroconverted subjects is defined as a subject who had either a pre vaccination (Day 0) titer \<1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a 4-fold increase in post-vaccination titer. Data for Day 192 are presented under Primary Outcome Measures.
Time frame: At Day 182 and Day 364
Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 182) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the pre-vaccination time point (Day 0) and the considered time point. Analyses were done by age stratum and overall.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1562902A 6 to 12 M Group | Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/1/2005 H5N1 (Day 182) | 31 Participants |
| GSK1562902A 6 to 12 M Group | Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/1/2005 H5N1 (Day 364) | 41 Participants |
| GSK1562902A 12 to 24 M Group | Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/1/2005 H5N1 (Day 364) | 26 Participants |
| GSK1562902A 12 to 24 M Group | Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/1/2005 H5N1 (Day 182) | 20 Participants |
| GSK1562902A 24 to 36 M Group | Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/1/2005 H5N1 (Day 182) | 28 Participants |
| GSK1562902A 24 to 36 M Group | Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/1/2005 H5N1 (Day 364) | 28 Participants |
| GSK1562902A Group | Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/1/2005 H5N1 (Day 182) | 83 Participants |
| GSK1562902A Group | Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/1/2005 H5N1 (Day 364) | 95 Participants |
Secondary
Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005
A seropositive subject is defined as a subject with a serum H5N1 HI antibody titer ≥ 1:10.
Time frame: At Day 0, Day 42, Day 182, Day 192 and Day 364
Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 0, 42, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the considered time point. Analyses were done by age stratum and overall.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1562902A 6 to 12 M Group | Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 | A/Indonesia/05/2005.HA [Day 192] | 33 Participants |
| GSK1562902A 6 to 12 M Group | Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 | A/Indonesia/05/2005.HA [Day 42] | 32 Participants |
| GSK1562902A 6 to 12 M Group | Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 | A/Indonesia/05/2005.HA [Day 364] | 41 Participants |
| GSK1562902A 6 to 12 M Group | Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 | A/Indonesia/05/2005.HA [Day 182] | 33 Participants |
| GSK1562902A 6 to 12 M Group | Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 | A/Indonesia/05/2005.HA [Day 0] | 0 Participants |
| GSK1562902A 12 to 24 M Group | Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 | A/Indonesia/05/2005.HA [Day 182] | 21 Participants |
| GSK1562902A 12 to 24 M Group | Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 | A/Indonesia/05/2005.HA [Day 192] | 21 Participants |
| GSK1562902A 12 to 24 M Group | Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 | A/Indonesia/05/2005.HA [Day 364] | 27 Participants |
| GSK1562902A 12 to 24 M Group | Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 | A/Indonesia/05/2005.HA [Day 42] | 24 Participants |
| GSK1562902A 12 to 24 M Group | Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 | A/Indonesia/05/2005.HA [Day 0] | 0 Participants |
| GSK1562902A 24 to 36 M Group | Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 | A/Indonesia/05/2005.HA [Day 182] | 29 Participants |
| GSK1562902A 24 to 36 M Group | Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 | A/Indonesia/05/2005.HA [Day 0] | 0 Participants |
| GSK1562902A 24 to 36 M Group | Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 | A/Indonesia/05/2005.HA [Day 42] | 29 Participants |
| GSK1562902A 24 to 36 M Group | Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 | A/Indonesia/05/2005.HA [Day 192] | 29 Participants |
| GSK1562902A 24 to 36 M Group | Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 | A/Indonesia/05/2005.HA [Day 364] | 32 Participants |
| GSK1562902A Group | Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 | A/Indonesia/05/2005.HA [Day 192] | 83 Participants |
| GSK1562902A Group | Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 | A/Indonesia/05/2005.HA [Day 42] | 85 Participants |
| GSK1562902A Group | Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 | A/Indonesia/05/2005.HA [Day 0] | 0 Participants |
| GSK1562902A Group | Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 | A/Indonesia/05/2005.HA [Day 182] | 83 Participants |
| GSK1562902A Group | Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 | A/Indonesia/05/2005.HA [Day 364] | 100 Participants |
Secondary
Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
A seropositive subject is defined as a subject with a serum H5N1 HI antibody titer ≥ 1:10.
Time frame: At Day 0, Day 182, Day 192 and Day 364
Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 0, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the considered time point. Analyses were done by age stratum and overall.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1562902A 6 to 12 M Group | Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005.HA [Day 0] | 6 Participants |
| GSK1562902A 6 to 12 M Group | Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005.HA [Day 182] 83 | 33 Participants |
| GSK1562902A 6 to 12 M Group | Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005.HA [Day 192] | 33 Participants |
| GSK1562902A 6 to 12 M Group | Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005.HA [Day 364] | 41 Participants |
| GSK1562902A 12 to 24 M Group | Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005.HA [Day 182] 83 | 21 Participants |
| GSK1562902A 12 to 24 M Group | Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005.HA [Day 192] | 21 Participants |
| GSK1562902A 12 to 24 M Group | Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005.HA [Day 364] | 27 Participants |
| GSK1562902A 12 to 24 M Group | Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005.HA [Day 0] | 3 Participants |
| GSK1562902A 24 to 36 M Group | Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005.HA [Day 192] | 29 Participants |
| GSK1562902A 24 to 36 M Group | Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005.HA [Day 182] 83 | 29 Participants |
| GSK1562902A 24 to 36 M Group | Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005.HA [Day 364] | 32 Participants |
| GSK1562902A 24 to 36 M Group | Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005.HA [Day 0] | 2 Participants |
| GSK1562902A Group | Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005.HA [Day 364] | 100 Participants |
| GSK1562902A Group | Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005.HA [Day 182] 83 | 83 Participants |
| GSK1562902A Group | Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005.HA [Day 0] | 11 Participants |
| GSK1562902A Group | Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/01/2005.HA [Day 192] | 83 Participants |
Secondary
Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
A seropositive subject is defined as a subject with serum neutralizing antibody titers ≥ 1:28
Time frame: Day 0, Day 42, Day 182, Day 192 and Day 364
Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 0, 42, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the considered time point. Analyses were done by age stratum and overall.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1562902A 6 to 12 M Group | Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 192] | 33 Participants |
| GSK1562902A 6 to 12 M Group | Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 42] | 24 Participants |
| GSK1562902A 6 to 12 M Group | Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 364] | 37 Participants |
| GSK1562902A 6 to 12 M Group | Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 182] | 32 Participants |
| GSK1562902A 6 to 12 M Group | Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 0] | 0 Participants |
| GSK1562902A 12 to 24 M Group | Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 182] | 21 Participants |
| GSK1562902A 12 to 24 M Group | Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 192] | 21 Participants |
| GSK1562902A 12 to 24 M Group | Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 364] | 27 Participants |
| GSK1562902A 12 to 24 M Group | Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 42] | 21 Participants |
| GSK1562902A 12 to 24 M Group | Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 0] | 0 Participants |
| GSK1562902A 24 to 36 M Group | Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 182] | 28 Participants |
| GSK1562902A 24 to 36 M Group | Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 0] | 1 Participants |
| GSK1562902A 24 to 36 M Group | Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 42] | 25 Participants |
| GSK1562902A 24 to 36 M Group | Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 192] | 29 Participants |
| GSK1562902A 24 to 36 M Group | Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 364] | 31 Participants |
| GSK1562902A Group | Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 192] | 83 Participants |
| GSK1562902A Group | Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 42] | 70 Participants |
| GSK1562902A Group | Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 0] | 1 Participants |
| GSK1562902A Group | Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 182] | 81 Participants |
| GSK1562902A Group | Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 364] | 95 Participants |
Secondary
Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
A seropositive subject is defined as a subject with serum neutralizing antibody titers ≥ 1:28.
Time frame: Day 0, Day 182, Day 192 and Day 364
Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 0, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the considered time point. Analyses were done by age stratum and overall.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1562902A 6 to 12 M Group | Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 0] | 0 Participants |
| GSK1562902A 6 to 12 M Group | Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 182] | 32 Participants |
| GSK1562902A 6 to 12 M Group | Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 192] | 33 Participants |
| GSK1562902A 6 to 12 M Group | Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 364] | 37 Participants |
| GSK1562902A 12 to 24 M Group | Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 182] | 21 Participants |
| GSK1562902A 12 to 24 M Group | Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 192] | 21 Participants |
| GSK1562902A 12 to 24 M Group | Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 364] | 27 Participants |
| GSK1562902A 12 to 24 M Group | Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 0] | 0 Participants |
| GSK1562902A 24 to 36 M Group | Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 192] | 29 Participants |
| GSK1562902A 24 to 36 M Group | Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 182] | 28 Participants |
| GSK1562902A 24 to 36 M Group | Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 364] | 31 Participants |
| GSK1562902A 24 to 36 M Group | Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 0] | 0 Participants |
| GSK1562902A Group | Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 364] | 95 Participants |
| GSK1562902A Group | Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 182] | 81 Participants |
| GSK1562902A Group | Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 0] | 0 Participants |
| GSK1562902A Group | Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 192] | 83 Participants |
Secondary
Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 Virus Strain
A seroprotected subject is defined as a subject with a serum H5N1 HI antibody titer ≥1:40.
Time frame: At Day 0, Day 42, Day 182, Day 192 and Day 364
Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 0, 42, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the considered time point. Analyses were done by age stratum and overall.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1562902A 6 to 12 M Group | Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 Virus Strain | A/Indonesia/05/2005 H5N1.HA [Day 192] | 33 Participants |
| GSK1562902A 6 to 12 M Group | Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 Virus Strain | A/Indonesia/05/2005 H5N1.HA [Day 42] | 32 Participants |
| GSK1562902A 6 to 12 M Group | Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 Virus Strain | A/Indonesia/05/2005 H5N1.HA [Day 364] | 41 Participants |
| GSK1562902A 6 to 12 M Group | Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 Virus Strain | A/Indonesia/05/2005 H5N1.HA [Day 182] | 32 Participants |
| GSK1562902A 6 to 12 M Group | Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 Virus Strain | A/Indonesia/05/2005 H5N1.HA [Day 0] | 0 Participants |
| GSK1562902A 12 to 24 M Group | Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 Virus Strain | A/Indonesia/05/2005 H5N1.HA [Day 182] | 21 Participants |
| GSK1562902A 12 to 24 M Group | Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 Virus Strain | A/Indonesia/05/2005 H5N1.HA [Day 192] | 21 Participants |
| GSK1562902A 12 to 24 M Group | Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 Virus Strain | A/Indonesia/05/2005 H5N1.HA [Day 364] | 27 Participants |
| GSK1562902A 12 to 24 M Group | Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 Virus Strain | A/Indonesia/05/2005 H5N1.HA [Day 42] | 24 Participants |
| GSK1562902A 12 to 24 M Group | Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 Virus Strain | A/Indonesia/05/2005 H5N1.HA [Day 0] | 0 Participants |
| GSK1562902A 24 to 36 M Group | Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 Virus Strain | A/Indonesia/05/2005 H5N1.HA [Day 182] | 29 Participants |
| GSK1562902A 24 to 36 M Group | Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 Virus Strain | A/Indonesia/05/2005 H5N1.HA [Day 0] | 0 Participants |
| GSK1562902A 24 to 36 M Group | Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 Virus Strain | A/Indonesia/05/2005 H5N1.HA [Day 42] | 29 Participants |
| GSK1562902A 24 to 36 M Group | Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 Virus Strain | A/Indonesia/05/2005 H5N1.HA [Day 192] | 29 Participants |
| GSK1562902A 24 to 36 M Group | Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 Virus Strain | A/Indonesia/05/2005 H5N1.HA [Day 364] | 32 Participants |
| GSK1562902A Group | Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 Virus Strain | A/Indonesia/05/2005 H5N1.HA [Day 192] | 83 Participants |
| GSK1562902A Group | Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 Virus Strain | A/Indonesia/05/2005 H5N1.HA [Day 42] | 85 Participants |
| GSK1562902A Group | Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 Virus Strain | A/Indonesia/05/2005 H5N1.HA [Day 0] | 0 Participants |
| GSK1562902A Group | Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 Virus Strain | A/Indonesia/05/2005 H5N1.HA [Day 182] | 82 Participants |
| GSK1562902A Group | Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 Virus Strain | A/Indonesia/05/2005 H5N1.HA [Day 364] | 100 Participants |
Secondary
Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
A seroprotected subject is defined as a subject with a serum H5N1 HI antibody titer ≥1:40. Data for Day 192 are presented under Primary Outcome Measures.
Time frame: Day 0, Day 182 and Day 364
Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 0 and Day 182) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the considered time point. Analyses were done by age stratum and overall.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1562902A 6 to 12 M Group | Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/1/2005 H5N1.HA [Day 0] | 0 Participants |
| GSK1562902A 6 to 12 M Group | Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/1/2005 H5N1.HA [Day 364] | 41 Participants |
| GSK1562902A 6 to 12 M Group | Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/1/2005 H5N1.HA [Day 182] | 31 Participants |
| GSK1562902A 12 to 24 M Group | Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/1/2005 H5N1.HA [Day 0] | 0 Participants |
| GSK1562902A 12 to 24 M Group | Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/1/2005 H5N1.HA [Day 364] | 27 Participants |
| GSK1562902A 12 to 24 M Group | Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/1/2005 H5N1.HA [Day 182] | 21 Participants |
| GSK1562902A 24 to 36 M Group | Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/1/2005 H5N1.HA [Day 182] | 29 Participants |
| GSK1562902A 24 to 36 M Group | Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/1/2005 H5N1.HA [Day 0] | 1 Participants |
| GSK1562902A 24 to 36 M Group | Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/1/2005 H5N1.HA [Day 364] | 32 Participants |
| GSK1562902A Group | Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/1/2005 H5N1.HA [Day 0] | 1 Participants |
| GSK1562902A Group | Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/1/2005 H5N1.HA [Day 364] | 100 Participants |
| GSK1562902A Group | Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | A/turkey/Turkey/1/2005 H5N1.HA [Day 182] | 81 Participants |
Secondary
Number of Subjects With a Booster Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Booster vaccine response is defined as: For seronegative subjects at Day 182, neutralizing antibody titers ≥ 1:56 at the considered time point after vaccination For seropositive subjects at Day 182, neutralizing antibody titers ≥ 4 fold from pre-vaccination (Day 182)
Time frame: At Day 192 and Day 364
Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the pre-booster vaccination time point (Day 182) and the considered time point. Analyses were done by age stratum and overall.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1562902A 6 to 12 M Group | Number of Subjects With a Booster Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 192] | 27 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With a Booster Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 364] | 32 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With a Booster Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 364] | 22 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With a Booster Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 192] | 19 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With a Booster Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 192] | 23 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With a Booster Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 364] | 22 Participants |
| GSK1562902A Group | Number of Subjects With a Booster Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 192] | 69 Participants |
| GSK1562902A Group | Number of Subjects With a Booster Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 364] | 76 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Solicited local symptoms assigned were pain, swelling and redness. Any was defined as occurrence of any local symptom regardless of intensity grade; Grade 3 pain was defined as cried when limb was moved spontaneously painful.
Time frame: During the 7-day post-vaccination period following each dose and across doses (Day 0 - Day 7, Day 21 - Day 28, Day 182 - Day 189)
Population: The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with at least one vaccine administration documented and with the symptom sheet filled-in. Analyses were done by age stratum and overall.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 2 | 10 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 1 | 2 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 1 | 2 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 1 | 0 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 1 | 1 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 1 | 0 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 1 | 14 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 2 | 0 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 2 | 3 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 2 | 0 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 2 | 2 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 2 | 0 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 3 | 20 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 3 | 3 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 3 | 11 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 3 | 0 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 3 | 5 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 3 | 0 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Across doses | 26 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Across doses | 4 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Across doses | 13 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Across doses | 0 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Across doses | 6 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Across doses | 0 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Across doses | 0 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 3 | 15 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 1 | 0 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Across doses | 6 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Across doses | 0 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 3 | 1 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 2 | 2 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 3 | 5 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 1 | 0 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 3 | 5 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 1 | 0 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 3 | 0 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Across doses | 6 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 2 | 0 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Across doses | 1 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 1 | 0 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 2 | 0 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 2 | 2 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 2 | 13 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Across doses | 19 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 1 | 5 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 2 | 0 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 1 | 1 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 3 | 0 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 2 | 0 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 2 | 14 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 2 | 1 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 2 | 1 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 2 | 0 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Across doses | 3 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Across doses | 5 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 2 | 0 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 3 | 18 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 3 | 3 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Across doses | 0 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 3 | 2 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 3 | 0 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Across doses | 0 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 3 | 1 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 3 | 0 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Across doses | 1 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 1 | 13 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 1 | 1 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Across doses | 21 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 1 | 2 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 1 | 0 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 1 | 1 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 1 | 0 Participants |
| GSK1562902A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Across doses | 13 Participants |
| GSK1562902A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Across doses | 22 Participants |
| GSK1562902A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 2 | 1 Participants |
| GSK1562902A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 1 | 32 Participants |
| GSK1562902A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 2 | 4 Participants |
| GSK1562902A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 2 | 0 Participants |
| GSK1562902A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 1 | 0 Participants |
| GSK1562902A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 1 | 3 Participants |
| GSK1562902A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 1 | 3 Participants |
| GSK1562902A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 2 | 6 Participants |
| GSK1562902A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Across doses | 10 Participants |
| GSK1562902A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 1 | 4 Participants |
| GSK1562902A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Across doses | 0 Participants |
| GSK1562902A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 3 | 18 Participants |
| GSK1562902A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Across doses | 66 Participants |
| GSK1562902A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 3 | 0 Participants |
| GSK1562902A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Across doses | 0 Participants |
| GSK1562902A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 3 | 7 Participants |
| GSK1562902A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 2 | 37 Participants |
| GSK1562902A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 3 | 11 Participants |
| GSK1562902A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 3 | 53 Participants |
| GSK1562902A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 2 | 0 Participants |
| GSK1562902A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 1 | 0 Participants |
| GSK1562902A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 3 | 0 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Solicited general symptoms assessed were diarrhoea/ vomiting, drowsiness, irritability/ fussiness, loss of appetite, fever (axillary). Any= occurrence of any general symptom regardless of intensity grade and relationship to the vaccine. Irritability/ fussiness grade 3=crying that could not be comforted/ prevented normal activity; Drowsiness grade 3= drowsiness that prevented normal activity; Loss of appetite grade 3= did not eat at all; Diarrhoea/ vomiting grade 3= diarrhoea/ vomiting that prevented normal activity; Related= general symptom assessed by the investigator as causally related to the study vaccination.
Time frame: During the 7-day post-vaccination period following each dose and across doses (Day 0 - Day 7, Day 21 - Day 28, Day 182 - Day 189)
Population: The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with at least one vaccine administration documented and with the symptom sheet filled-in. Analyses were done by age stratum and overall.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Diarrhoea/vomiting Dose 1 | 10 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Across doses | 19 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Diarrhoea/vomiting Dose 3 | 1 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability/fussiness Dose 1 | 19 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever (Axillary) Dose 3 | 19 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Diarrhoea/vomiting Dose 3 | 9 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Dose 3 | 16 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever (Axillary) Dose 3 | 3 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Dose 3 | 2 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Dose 3 | 16 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Dose 1 | 9 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever (Axillary) Dose 3 | 20 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability/fussiness Dose 3 | 28 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability/fussiness Dose 3 | 7 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Diarrhoea/vomiting Dose 3 | 10 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Dose 3 | 15 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability/fussiness Dose 3 | 26 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Dose 3 | 16 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Across doses | 2 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Dose 3 | 2 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Dose 1 | 0 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Dose 1 | 5 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Dose 1 | 10 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Across doses | 22 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever (Axillary) Dose 1 | 4 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever (Axillary) Dose 1 | 0 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Diarrhoea/vomiting Dose 1 | 1 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability/fussiness Across doses | 35 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever (Axillary) Dose 1 | 3 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever (Axillary) Across doses | 5 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Diarrhoea/vomiting Dose 2 | 8 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Dose 1 | 1 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability/fussiness Across doses | 10 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Diarrhoea/vomiting Dose 2 | 0 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Diarrhoea/vomiting Dose 2 | 7 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability/fussiness Across doses | 35 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Dose 2 | 8 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Dose 2 | 1 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Dose 1 | 8 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Across doses | 21 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Dose 2 | 8 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability/fussiness Dose 2 | 14 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Across doses | 3 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability/fussiness Dose 2 | 1 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever (Axillary) Across doses | 29 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability/fussiness Dose 2 | 13 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability/fussiness Dose 1 | 21 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Across doses | 22 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Dose 2 | 8 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Dose 2 | 0 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever (Axillary) Across doses | 28 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Diarrhoea/vomiting Across doses | 14 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Dose 2 | 8 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever (Axillary) Dose 2 | 14 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability/fussiness Dose 1 | 3 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Diarrhoea/vomiting Across doses | 1 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever (Axillary) Dose 2 | 2 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever (Axillary) Dose 2 | 14 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Diarrhoea/vomiting Dose 1 | 6 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Diarrhoea/vomiting Across doses | 17 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever (Axillary) Dose 2 | 12 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Diarrhoea/vomiting Dose 3 | 3 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Diarrhoea/vomiting Dose 2 | 3 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever (Axillary) Dose 3 | 15 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Across doses | 18 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Diarrhoea/vomiting Dose 3 | 0 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Dose 2 | 5 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability/fussiness Dose 2 | 15 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Diarrhoea/vomiting Dose 2 | 0 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Diarrhoea/vomiting Dose 3 | 2 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability/fussiness Dose 1 | 10 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever (Axillary) Dose 3 | 5 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Dose 1 | 0 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Dose 3 | 6 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Diarrhoea/vomiting Dose 1 | 1 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability/fussiness Across doses | 23 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Across doses | 17 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Dose 3 | 0 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Across doses | 2 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever (Axillary) Dose 3 | 15 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Diarrhoea/vomiting Dose 2 | 2 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Dose 3 | 6 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Diarrhoea/vomiting Dose 1 | 1 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Diarrhoea/vomiting Across doses | 1 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever (Axillary) Dose 2 | 3 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability/fussiness Dose 3 | 15 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Dose 1 | 12 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Dose 3 | 12 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Dose 2 | 12 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability/fussiness Dose 3 | 0 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever (Axillary) Across doses | 19 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Across doses | 17 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Dose 2 | 6 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability/fussiness Dose 3 | 15 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever (Axillary) Across doses | 19 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Dose 3 | 0 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Dose 2 | 1 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Dose 3 | 12 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability/fussiness Dose 1 | 14 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Diarrhoea/vomiting Across doses | 5 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever (Axillary) Dose 2 | 12 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Dose 1 | 1 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever (Axillary) Across doses | 8 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Across doses | 18 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Dose 2 | 10 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Dose 1 | 8 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Dose 1 | 7 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Across doses | 1 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Dose 2 | 1 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever (Axillary) Dose 1 | 6 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Dose 1 | 9 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability/fussiness Across doses | 23 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability/fussiness Dose 2 | 17 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever (Axillary) Dose 1 | 2 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Diarrhoea/vomiting Dose 1 | 6 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability/fussiness Dose 1 | 0 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Diarrhoea/vomiting Across doses | 11 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever (Axillary) Dose 1 | 5 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability/fussiness Dose 2 | 3 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability/fussiness Across doses | 3 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability/fussiness Dose 3 | 2 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Diarrhoea/vomiting Dose 1 | 3 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Diarrhoea/vomiting Dose 1 | 0 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Diarrhoea/vomiting Dose 1 | 2 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Dose 1 | 5 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Dose 1 | 0 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Dose 1 | 5 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability/fussiness Dose 1 | 9 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability/fussiness Dose 1 | 0 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability/fussiness Dose 1 | 8 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Dose 1 | 6 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Dose 1 | 0 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Dose 1 | 5 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever (Axillary) Dose 1 | 4 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever (Axillary) Dose 1 | 0 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever (Axillary) Dose 1 | 3 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Diarrhoea/vomiting Dose 2 | 2 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Diarrhoea/vomiting Dose 2 | 0 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Diarrhoea/vomiting Dose 2 | 1 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Dose 2 | 7 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Dose 2 | 1 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Dose 2 | 7 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability/fussiness Dose 2 | 10 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability/fussiness Dose 2 | 0 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability/fussiness Dose 2 | 10 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Dose 2 | 9 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Dose 2 | 0 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Dose 2 | 8 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever (Axillary) Dose 2 | 10 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever (Axillary) Dose 2 | 1 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever (Axillary) Dose 2 | 10 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Diarrhoea/vomiting Dose 3 | 3 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Diarrhoea/vomiting Dose 3 | 0 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Diarrhoea/vomiting Dose 3 | 1 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Dose 3 | 10 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Dose 3 | 1 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Dose 3 | 7 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability/fussiness Dose 3 | 11 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability/fussiness Dose 3 | 10 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Dose 3 | 9 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Dose 3 | 2 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Dose 3 | 7 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever (Axillary) Dose 3 | 19 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever (Axillary) Dose 3 | 3 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever (Axillary) Dose 3 | 18 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Diarrhoea/vomiting Across doses | 7 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Diarrhoea/vomiting Across doses | 0 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Diarrhoea/vomiting Across doses | 3 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Across doses | 12 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Across doses | 2 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Across doses | 12 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability/fussiness Across doses | 15 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability/fussiness Across doses | 2 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability/fussiness Across doses | 14 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Across doses | 14 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Across doses | 2 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Across doses | 14 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever (Axillary) Across doses | 21 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever (Axillary) Across doses | 4 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever (Axillary) Across doses | 20 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever (Axillary) Dose 2 | 36 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever (Axillary) Dose 2 | 6 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability/fussiness Dose 1 | 44 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Diarrhoea/vomiting Across doses | 35 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever (Axillary) Dose 2 | 36 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Dose 2 | 21 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Diarrhoea/vomiting Dose 1 | 2 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Diarrhoea/vomiting Across doses | 2 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Dose 2 | 1 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Dose 2 | 23 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Across doses | 50 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Diarrhoea/vomiting Across doses | 22 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability/fussiness Dose 2 | 38 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability/fussiness Dose 2 | 4 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Dose 1 | 20 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Across doses | 52 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability/fussiness Dose 2 | 41 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Dose 2 | 25 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Dose 1 | 1 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Across doses | 6 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Dose 2 | 3 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Dose 2 | 27 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Diarrhoea/vomiting Dose 1 | 19 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Across doses | 50 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Diarrhoea/vomiting Dose 2 | 10 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Diarrhoea/vomiting Dose 2 | 0 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever (Axillary) Across doses | 69 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability/fussiness Across doses | 73 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Diarrhoea/vomiting Dose 2 | 13 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever (Axillary) Dose 1 | 11 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Dose 1 | 24 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability/fussiness Across doses | 15 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever (Axillary) Dose 1 | 2 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever (Axillary) Dose 1 | 14 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Diarrhoea/vomiting Dose 1 | 9 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability/fussiness Across doses | 72 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Dose 1 | 18 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Dose 1 | 1 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever (Axillary) Across doses | 67 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Across doses | 54 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Dose 3 | 37 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability/fussiness Dose 3 | 51 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Dose 1 | 27 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Dose 3 | 4 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability/fussiness Dose 3 | 9 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability/fussiness Dose 3 | 54 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability/fussiness Dose 1 | 37 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Dose 3 | 34 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Dose 3 | 29 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Dose 3 | 3 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever (Axillary) Across doses | 17 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever (Axillary) Dose 3 | 54 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Dose 3 | 32 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Diarrhoea/vomiting Dose 3 | 12 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Across doses | 6 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever (Axillary) Dose 3 | 11 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Diarrhoea/vomiting Dose 3 | 1 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Diarrhoea/vomiting Dose 3 | 16 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability/fussiness Dose 1 | 3 Participants |
| GSK1562902A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever (Axillary) Dose 3 | 52 Participants |
Secondary
Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
Vaccine response is defined as: For initially seronegative subjects, neutralizing antibody titer ≥ 1:56 at the considered time point after vaccination For initially seropositive subjects, neutralizing antibody titer ≥ 4 fold from pre-vaccination (Day 0)
Time frame: At Day 42, Day 182, Day 192 and Day 364
Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 42, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the pre-vaccination time point (Day 0) and the considered time point. Analyses were done by age stratum and overall.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1562902A 6 to 12 M Group | Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 42] | 22 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 182] | 28 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 192] | 29 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 364] | 33 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 182] | 19 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 192] | 19 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 364] | 25 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 42] | 19 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 192] | 24 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 182] | 22 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 364] | 25 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 42] | 21 Participants |
| GSK1562902A Group | Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 364] | 83 Participants |
| GSK1562902A Group | Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 182] | 69 Participants |
| GSK1562902A Group | Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 42] | 62 Participants |
| GSK1562902A Group | Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 192] | 72 Participants |
Secondary
Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Vaccine response is defined as: For initially seronegative subjects, neutralizing antibody titer ≥ 1:56 at the considered time point after vaccination For initially seropositive subjects, neutralizing antibody titer ≥ 4 fold from pre-vaccination (Day 0)
Time frame: At Day 182, Day 192 and Day 364
Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the pre-vaccination time point (Day 0) and the considered time point. Analyses were done by age stratum and overall.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1562902A 6 to 12 M Group | Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 182] | 22 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 364] | 33 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 192] | 29 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 182] | 17 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 364] | 25 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 192] | 19 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 192] | 24 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 182] | 19 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 364] | 25 Participants |
| GSK1562902A Group | Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 182] | 58 Participants |
| GSK1562902A Group | Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 364] | 83 Participants |
| GSK1562902A Group | Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 192] | 72 Participants |
Secondary
Number of Subjects With Medically-attended Events (MAEs)
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed.
Time frame: During the entire study period (from Day 0 to Day 364)
Population: The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with at least one vaccine administration documented. Analyses were done by age stratum and overall.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1562902A 6 to 12 M Group | Number of Subjects With Medically-attended Events (MAEs) | 29 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Medically-attended Events (MAEs) | 19 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Medically-attended Events (MAEs) | 20 Participants |
| GSK1562902A Group | Number of Subjects With Medically-attended Events (MAEs) | 68 Participants |
Secondary
Number of Subjects With Potential Immune-mediated Disease (pIMDs)
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Time frame: During the entire study period (from day 0 to Day 364)
Population: The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with at least one vaccine administration documented. Analyses were done by age stratum and overall.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1562902A 6 to 12 M Group | Number of Subjects With Potential Immune-mediated Disease (pIMDs) | 0 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Potential Immune-mediated Disease (pIMDs) | 0 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Potential Immune-mediated Disease (pIMDs) | 0 Participants |
| GSK1562902A Group | Number of Subjects With Potential Immune-mediated Disease (pIMDs) | 0 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed included 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 Day 0 to 364)
Population: The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with at least one vaccine administration documented. Analyses were done by age stratum and overall.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1562902A 6 to 12 M Group | Number of Subjects With Serious Adverse Events (SAEs) | 5 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Serious Adverse Events (SAEs) | 4 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| GSK1562902A Group | Number of Subjects With Serious Adverse Events (SAEs) | 9 Participants |
Secondary
Number of Subjects With Unsolicited Adverse Events (AEs)
An AE is 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. Any was defined as an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. Grade 3 was defined as an AE which prevented normal, everyday activities. Related was defined as an AE assessed by the investigator as causally related to the study vaccination.
Time frame: During a 21 day follow-up period after each vaccination (Day 0 - Day 21, Day 21 - Day 42, Day 182 - Day 203)
Population: The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with at least one vaccine administration documented. Analyses were done by age stratum and overall.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1562902A 6 to 12 M Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Any AE(s) | 29 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Related AE(s) | 13 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 5 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Any AE(s) | 19 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Related AE(s) | 5 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 3 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 2 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Any AE(s) | 24 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Related AE(s) | 7 Participants |
| GSK1562902A Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Any AE(s) | 72 Participants |
| GSK1562902A Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Related AE(s) | 25 Participants |
| GSK1562902A Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 10 Participants |
Secondary
Number of Subjects With Unsolicited Adverse Events (AEs)
An AE is 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. Any was defined as an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. Grade 3 was defined as an AE which prevented normal, everyday activities. Related was defined as an AE assessed by the investigator as causally related to the study vaccination.
Time frame: During an 84 day follow-up period after each vaccination (Day 0 - Day 84, Day 21 - Day 105, Day 182 - Day 266)
Population: The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with at least one vaccine administration documented. Analyses were done by age stratum and overall.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1562902A 6 to 12 M Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Any AE(s) | 32 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Related AE(s) | 9 Participants |
| GSK1562902A 6 to 12 M Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 4 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Any AE(s) | 23 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Related AE(s) | 3 Participants |
| GSK1562902A 12 to 24 M Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 4 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 2 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Any AE(s) | 22 Participants |
| GSK1562902A 24 to 36 M Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Related AE(s) | 6 Participants |
| GSK1562902A Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Any AE(s) | 77 Participants |
| GSK1562902A Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Related AE(s) | 18 Participants |
| GSK1562902A Group | Number of Subjects With Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 10 Participants |
Secondary
Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
Titers were presented as geometric mean titers (GMTs).
Time frame: Day 0, Day 42, Day 182, Day 192 and Day 364
Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 0, 42, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the considered time point. Analyses were done by age stratum and overall.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1562902A 6 to 12 M Group | Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 192] | 12667.0 Titer |
| GSK1562902A 6 to 12 M Group | Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 42] | 1785.9 Titer |
| GSK1562902A 6 to 12 M Group | Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 364] | 6420.9 Titer |
| GSK1562902A 6 to 12 M Group | Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 182] | 526.6 Titer |
| GSK1562902A 6 to 12 M Group | Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 0] | NA Titer |
| GSK1562902A 12 to 24 M Group | Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 182] | 483.3 Titer |
| GSK1562902A 12 to 24 M Group | Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 192] | 11031.5 Titer |
| GSK1562902A 12 to 24 M Group | Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 364] | 4730.9 Titer |
| GSK1562902A 12 to 24 M Group | Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 42] | 2080.4 Titer |
| GSK1562902A 12 to 24 M Group | Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 0] | NA Titer |
| GSK1562902A 24 to 36 M Group | Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 182] | 353.4 Titer |
| GSK1562902A 24 to 36 M Group | Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 0] | 14.4 Titer |
| GSK1562902A 24 to 36 M Group | Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 42] | 1755.2 Titer |
| GSK1562902A 24 to 36 M Group | Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 192] | 9883.1 Titer |
| GSK1562902A 24 to 36 M Group | Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 364] | 2422.9 Titer |
| GSK1562902A Group | Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 192] | 11215.7 Titer |
| GSK1562902A Group | Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 42] | 1858.0 Titer |
| GSK1562902A Group | Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 0] | 14.1 Titer |
| GSK1562902A Group | Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 182] | 448.7 Titer |
| GSK1562902A Group | Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain | Flu A/Ind/05/05 (H5N1) [Day 364] | 4283.3 Titer |
Secondary
Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Titers were presented as geometric mean titers (GMTs).
Time frame: Day 0, Day 182, Day 192 and Day 364
Population: The analysis was performed on the ATP cohort for immunogenicity at Month 6 (Day 0, 182 and 192) and Month 12 (Day 364), including all evaluable subjects for whom considered assay results were available for the considered time point. Analyses were done by age stratum and overall.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1562902A 6 to 12 M Group | Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 0] | NA Titer |
| GSK1562902A 6 to 12 M Group | Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 182] | 137.5 Titer |
| GSK1562902A 6 to 12 M Group | Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 192] | 7391.0 Titer |
| GSK1562902A 6 to 12 M Group | Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 364] | 4149.7 Titer |
| GSK1562902A 12 to 24 M Group | Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 182] | 124.9 Titer |
| GSK1562902A 12 to 24 M Group | Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 192] | 5464.2 Titer |
| GSK1562902A 12 to 24 M Group | Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 364] | 3030.8 Titer |
| GSK1562902A 12 to 24 M Group | Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 0] | NA Titer |
| GSK1562902A 24 to 36 M Group | Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 192] | 3349.4 Titer |
| GSK1562902A 24 to 36 M Group | Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 182] | 113.2 Titer |
| GSK1562902A 24 to 36 M Group | Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 364] | 1317.8 Titer |
| GSK1562902A 24 to 36 M Group | Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 0] | NA Titer |
| GSK1562902A Group | Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 364] | 2610.2 Titer |
| GSK1562902A Group | Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 182] | 125.4 Titer |
| GSK1562902A Group | Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 0] | NA Titer |
| GSK1562902A Group | Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain | Flu A/Turk/01/05 (H5N1) [Day 192] | 5192.9 Titer |