Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK investigational vaccine GSK1557482A · 1 trial · 1 indication
The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Titers were expressed as geometric mean antibody titers (GMTs).
The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroconversion was defined as the percentage of vaccinees 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 four-fold increase in post-vaccination titer.
| Arm | Type | Description |
|---|---|---|
| Flulaval Group | EXPERIMENTAL | subjects received Flulaval™ vaccine according to their priming status and age: * 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 * 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid. |
| Fluzone Group | ACTIVE_COMPARATOR | subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age: * 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 * 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid. |
| Name | Type | Description |
|---|---|---|
| GSK investigational vaccine GSK1557482A | BIOLOGICAL | One intramuscular injection for primed subjects, two intramuscular injections for unprimed subjects |
| Fluzone® | BIOLOGICAL | One intramuscular injection for primed subjects, two intramuscular injections for unprimed subjects |
Inclusion Criteria: * Subjects and/or subject parent(s)/Legally Acceptable Representative(s) (LAR) who the investigator believes can and will comply with the requirements of the protocol. * A male or female child aged between 3 years and 17 years of age at the time of the first vaccination; childre...
GSK1557482A is an investigational vaccine being studied for the prevention of influenza. It is currently in Phase 3 clinical development and has been evaluated in a completed trial involving children aged 3 years and older in the United States.
GSK1557482A is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The vaccine is currently in Phase 3 clinical development for influenza.
GSK1557482A is in Phase 3 clinical development. It is an investigational vaccine for influenza and has not yet been approved by regulatory authorities. One Phase 3 trial has been completed.
GSK1557482A has been studied in one completed Phase 3 clinical trial, identified as NCT00980005. This randomized, double-blind, active-controlled study assessed the immunogenicity and safety of the investigational influenza vaccine in 2,116 children in the United States.
GSK1557482A is described as a monoclonal antibody in some contexts, but it is being investigated as an influenza vaccine. The Phase 3 trial evaluated its immunogenicity and safety in children, indicating it is intended to elicit an immune response against influenza.