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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...
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| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD4117, AZD5315 |
GSK1557482A is an investigational influenza vaccine developed by GSK plc. It is a vaccine candidate studied for the prevention of influenza, also known as the flu. The vaccine was evaluated in a Phase 3 clinical trial in children, and it is not an approved product.
GSK1557482A is being studied for use against influenza in children. The Phase 3 trial enrolled healthy volunteers aged 3 years and older in the United States. As an investigational vaccine, it is not approved for use, and its intended use is prevention of influenza infection.
GSK1557482A is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program evaluating this investigational influenza vaccine. The company conducted the Phase 3 study of the vaccine in children in the United States.
GSK1557482A is in Phase 3 development. The vaccine has been evaluated in a completed Phase 3 trial, and it is an investigational product rather than an approved vaccine. No active trials of GSK1557482A are currently listed.
GSK1557482A was studied in the Phase 3 trial NCT00980005, titled Study to Assess the Immunogenicity and Safety of an Investigational Influenza Vaccine in Children. That trial is completed and enrolled 2,116 participants aged 3 years and older in the United States. It was randomized, double blind, and active controlled.
The Phase 3 trial NCT00980005 was a randomized, double-blind, active-controlled study of GSK1557482A in children. It enrolled 2,116 healthy volunteers aged 3 years and older in the United States and assessed immunogenicity and safety. The trial is completed, and no biomarker-based selection was used.