Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Quadrivalent seasonal influenza vaccine GSK2282512A · 2 trials · 1 indication
Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Results for Day 21 for the subjects in the GSK2282512A Group are the results specific to this primary outcome measure.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination 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. The vaccine strains assessed were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains.
| Arm | Type | Description |
|---|---|---|
| GSK2282512A 1 Group | EXPERIMENTAL | Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| GSK2282512A 2 Group | EXPERIMENTAL | Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| GSK2282512A 3 Group | EXPERIMENTAL | Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| Victoria Strain FluLaval Group | ACTIVE_COMPARATOR | Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| Yamagata Strain FluLaval Group | ACTIVE_COMPARATOR | Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| Victoria strain Fluarix Group | ACTIVE_COMPARATOR | Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| Yamagata strain Fluarix Group | ACTIVE_COMPARATOR | Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| Name | Type | Description |
|---|---|---|
| Quadrivalent seasonal influenza vaccine GSK2282512A | BIOLOGICAL | Single intramuscular dose |
| FluLavalTM-VB | BIOLOGICAL | Single intramuscular dose |
| FluLavalTM-YB | BIOLOGICAL | Single intramuscular dose |
| Fluarix™ VB | BIOLOGICAL | For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects of 9 to 17 years of age, single intramuscular dose. |
| Fluarix™ YB | BIOLOGICAL | For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects of 9 to 17 years of age, single intramuscular dose |
Inclusion Criteria: * Subjects who the investigator believes can and will comply with the requirements of the protocol * A male or female 18 years of age or older, in stable health, as established by medical history and physical examination before entering into the study. * Written informed consent...