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Also known as GSK2282512A, FluLaval® Quadrivalent
Quadrivalent seasonal influenza vaccine GSK2282512A · 2 trials · 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.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains assessed were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains.
| 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. |
| Victoria strain Fluarix Group | ACTIVE_COMPARATOR | Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| Yamagata strain Fluarix Group | ACTIVE_COMPARATOR | Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ 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 |
| Fluarix™ VB | BIOLOGICAL | For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects of 9 to 17 years of age, single intramuscular dose. |
| Fluarix™ YB | BIOLOGICAL | For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects of 9 to 17 years of age, 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...
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| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 3 | PHASE3 | mRNA Seasonal Flu vaccine, Flu/COVID-19 mRNA combination vaccine |
| Moderna, Inc. | MRNA | 2 | PHASE3 | mRNA-1018-H5, mRNA-1010, Fluarix Trivalent |
| Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | CDTX | 1 | PHASE3 | CD388 |
| Traws Pharma, Inc. | TRAW | 2 | PHASE2 | TRX-100 |
| Sanofi SA Sponsored ADR | SNY | 4 | PHASE1 | H5N8 pandemic influenza vaccine (adjuvanted) |
| Hoffmann-La Roche | RHHBY | 2 | PHASE3 | Baloxavir Marboxil |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD4117, AZD5315 |
| Sinovac Biotech Ltd. | SVA | 1 | PHASE1 | Cell-based Trivalent Split Influenza Virus Vaccine, Egg-based Trivalent Split Influenza Virus Vaccine |
Quadrivalent seasonal influenza vaccine GSK2282512A is an investigational vaccine developed by GSK plc for the prevention of influenza. It is designed to protect against four influenza virus strains and has been studied in Phase 3 clinical trials in both children and adults.
Quadrivalent seasonal influenza vaccine GSK2282512A is being developed for the prevention of influenza, a contagious respiratory illness. It is intended for use in children and adults, as studied in Phase 3 clinical trials.
Quadrivalent seasonal influenza vaccine GSK2282512A is being developed by GSK plc, which trades under the ticker symbol GSK. GSK Biologicals, the company's vaccine division, conducted the clinical trials for this candidate.
Quadrivalent seasonal influenza vaccine GSK2282512A is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by the FDA. Two Phase 3 trials have been completed, with no active trials currently ongoing.
Quadrivalent seasonal influenza vaccine GSK2282512A has been evaluated in two completed Phase 3 trials: NCT01198756 in children and NCT01196975 in adults. Both were randomized, double-blind, and active-controlled, enrolling a total of 4,816 participants across multiple countries.