Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GlaxoSmithKline Biologicals' influenza vaccine GSK576389A · 1 trial · 1 indication
Antibody titers were expressed as Geometric mean titers (GMTs) against each of the 3 vaccine strains in greater than or equal to 65 years age groups only. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
| Arm | Type | Description |
|---|---|---|
| Influenza vaccine GSK576389A formulation 1 Group | EXPERIMENTAL | Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A. |
| Influenza vaccine GSK576389A formulation 2 Group | EXPERIMENTAL | Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A. |
| Influenza vaccine GSK576389A formulation 3 Group | EXPERIMENTAL | Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A. |
| Influenza vaccine GSK576389A formulation 4 Group | EXPERIMENTAL | Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A. |
| Influenza vaccine GSK576389A formulation 5 Group | EXPERIMENTAL | Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A. |
| Influenza vaccine GSK576389A formulation 6 Group | EXPERIMENTAL | Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A. |
| Influenza vaccine GSK576389A formulation 7 Group | EXPERIMENTAL | Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A. |
| Influenza vaccine GSK576389A formulation 8 Group | EXPERIMENTAL | Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A. |
| Fluarix elderly Group | ACTIVE_COMPARATOR | Subjects aged ≥65 years received one dose of Fluarix vaccine. |
| Fluarix young Group | ACTIVE_COMPARATOR | Subjects aged 18-40 years received one dose of Fluarix vaccine. |
| Name | Type | Description |
|---|---|---|
| GlaxoSmithKline Biologicals' influenza vaccine GSK576389A | BIOLOGICAL | Single dose, Intramuscular injection, 8 different formulations were tested (one per group) |
| Fluarix | BIOLOGICAL | Single dose, Intramuscular injection |
Inclusion Criteria: * Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. * A male or female aged 18-40 years old or 65 years or older at the time of the vaccination. * Written informed consent obtained from the...