Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK Bio's influenza vaccine GSK576389A · 1 trial · 1 indication
Antibody titers were expressed as Geometric mean titers (GMTs). The H1N1 vaccine strains included A/New Caledonia and A/Solomon Islands antigens. A/New Caledonia vaccine strain was administered to both groups receiving the adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season. A/Solomon Islands vaccine strain was administered to both groups receiving the adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season.
| Arm | Type | Description |
|---|---|---|
| GSK576389A- 2006/2007 Season - 1 container Group | EXPERIMENTAL | Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container. |
| GSK576389A - 2006/2007 Season - 2 containers Group | EXPERIMENTAL | Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers. |
| Fluarix 2006/2007 Season Group | ACTIVE_COMPARATOR | Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season. |
| GSK576389A - 2007/2008 Season - 1 container Group | EXPERIMENTAL | Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container. |
| GSK576389A - 2007/2008 Season - 2 containers Group | EXPERIMENTAL | Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers. |
| Fluarix 2007/2008 Season Group | ACTIVE_COMPARATOR | Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season. |
| Name | Type | Description |
|---|---|---|
| GSK Bio's influenza vaccine GSK576389A [NH 2006/07 season] | BIOLOGICAL | Single dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2006-2007 influenza season. |
| GSK Bio's influenza vaccine GSK576389A [NH 2007/08 season] | BIOLOGICAL | Single dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2007-2008 influenza season. |
| Fluarix [NH 2006/07 season] | BIOLOGICAL | Single dose, intramuscular injection, Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season. |
| Fluarix [NH 2007/08 season] | BIOLOGICAL | Single dose, intramuscular injection, Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season. |
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 65 years or older at the time of the vaccination. * Written informed consent obtained from the subject. * Free of...