Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Influenza Vaccine GSK1247446A - 4 different formulations
Influenza Vaccine GSK1247446A- 4 different formulations · 1 trial · 1 indication
Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA). The seropositivity cut-off assay was 1:10. The results for Day 0 and Day 21 are the primary efficacy variables.
| Arm | Type | Description |
|---|---|---|
| GSK1247446A 1 Group | EXPERIMENTAL | Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| GSK1247446A 2 Group | EXPERIMENTAL | Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| GSK1247446A 3 Group | EXPERIMENTAL | Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| GSK1247446A 4 Group | EXPERIMENTAL | Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| Fluarix Group | ACTIVE_COMPARATOR | Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| Name | Type | Description |
|---|---|---|
| Influenza Vaccine GSK1247446A - 4 different formulations | BIOLOGICAL | Single dose, Intramuscular injection |
| Fluarix™ | BIOLOGICAL | Single dose, Intramuscular injection |
Inclusion Criteria: * Only subjects who the investigator believes that they can and will comply with the requirements of the protocol . * A male or female between, and including, 18 - 64 years of age at the time of vaccination. * Written informed consent obtained from the subject. * Healthy subject...