Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FluLavalTM-VB · 1 trial · 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.
| 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. |
| Name | Type | Description |
|---|---|---|
| Quadrivalent seasonal influenza vaccine GSK2282512A | BIOLOGICAL | Single intramuscular dose |
| FluLavalTM-VB | BIOLOGICAL | Single intramuscular dose |
| FluLavalTM-YB | BIOLOGICAL | 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...
FluLavalTM-VB is a seasonal influenza vaccine being developed for the prevention of influenza in adults. It is currently in Phase 3 clinical development and is being studied in adults aged 18 years and older.
FluLavalTM-VB is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity.
FluLavalTM-VB is in Phase 3 clinical development. It is an investigational vaccine and has not yet been approved by regulatory authorities. A Phase 3 clinical trial has been completed to evaluate its safety and immunogenicity in adults.
FluLavalTM-VB has been studied in a Phase 3 clinical trial with the identifier NCT01196975. This completed trial evaluated the safety and immunogenicity of the seasonal influenza vaccine in 1,707 adults across the United States, Canada, and Mexico.
FluLavalTM-VB is a seasonal influenza vaccine designed to stimulate the immune system to produce antibodies against influenza viruses. It is administered to adults to help protect against seasonal flu infection.