Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00980005 | Study to Assess the Immunogenicity and Safety of an Investigational Influenza Vaccine in Children | PHASE3 | COMPLETED | 2,116 | — | — | Oct 13, 2009 | Jun 17, 2010 | Sep 21, 2018 | 28 | United States |
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...