Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01196975 | A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Adults | PHASE3 | COMPLETED | 1,707 | — | — | Oct 1, 2010 | Jun 24, 2011 | Sep 21, 2018 | 12 | United States, Canada +1 |
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...