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 ...
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GSK1562902A is an investigational vaccine developed by GSK plc for influenza. It is a Phase 2 candidate studied in children, specifically for pandemic influenza. The vaccine was evaluated in a completed clinical trial that enrolled 113 healthy volunteers aged 6 months and older in Australia and Singapore.
GSK1562902A is being developed for the prevention of influenza, including pandemic influenza. Its only recorded clinical trial studied its use in children, assessing immunogenicity and safety. The vaccine is not approved and remains investigational.
GSK1562902A is made by GSK plc, which trades under the ticker GSK. GSK Biologicals is the developer of this investigational influenza vaccine.
GSK1562902A is in Phase 2 development. It has completed one Phase 2 clinical trial, and no active trials are currently listed. The vaccine is investigational and has not been approved for any indication.
GSK1562902A has been studied in one completed Phase 2 trial, NCT01323946, titled "Study to Evaluate the Immunogenicity and Safety of an Investigational Pandemic Influenza Vaccine in Children." The trial enrolled 113 healthy volunteers aged 6 months and older in Australia and Singapore.