Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK Biologicals' investigational vaccine GSK1562902A · 1 trial · 1 indication
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 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).
A seroprotected subject is defined as a subject with a serum H5N1 HI antibody titer ≥1:40.
| Arm | Type | Description |
|---|---|---|
| GSK1562902A 6 to 12 M Group | EXPERIMENTAL | 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. |
| GSK1562902A 12 to 24 M Group | EXPERIMENTAL | 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. |
| GSK1562902A 24 to 36 M Group | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals' investigational vaccine GSK1562902A | BIOLOGICAL | Three intramuscular injections |
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 ...