Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Candidate Influenza Vaccine GSK1247446A- 2 different formulations · 1 trial · 1 indication
Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia, A/New York and B/Malaysia. The reference seropositivity cut-off value was ≥ 1:10.
| Arm | Type | Description |
|---|---|---|
| GSK1247446A-AS03 Group | EXPERIMENTAL | Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| GSK1247446A Group | EXPERIMENTAL | Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| Fluarix Group | ACTIVE_COMPARATOR | Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| Name | Type | Description |
|---|---|---|
| Candidate Influenza Vaccine GSK1247446A - 2 different formulations | BIOLOGICAL | Single dose, Intramuscular injection |
| FluarixTM | BIOLOGICAL | Single dose, Intramuscular injection |
Inclusion criteria: * A male or female age 60 years or older at the time of the vaccination. * Subjects who the investigator believes can and will comply with the requirements of the protocol * Written informed consent obtained from the subject. * Free of an acute aggravation of the health status a...