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...
Top 8 of 11 competitors
| 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 |
GSK Bio's influenza vaccine GSK576389A is an investigational vaccine developed by GSK plc for the prevention of influenza. It is a Phase 2 vaccine candidate that has been evaluated in a completed clinical trial in adults aged 65 years and over. It is not an approved product.
GSK Bio's influenza vaccine GSK576389A is being developed for the prevention of influenza. Its clinical program has focused on adults aged 65 years and over, the population studied in its completed Phase 2 trial. It is an investigational vaccine and is not approved for use.
GSK Bio's influenza vaccine GSK576389A is made by GSK plc, which trades under the ticker GSK. GSK Bio is the company's biologics and vaccines unit. GSK plc is the developer of record for the vaccine candidate.
GSK Bio's influenza vaccine GSK576389A is in Phase 2 development. It is an investigational vaccine and is not approved. Its Phase 2 trial has been completed, and no active trials of the vaccine are listed.
GSK Bio's influenza vaccine GSK576389A has been studied in one completed Phase 2 trial, NCT00532298, titled Non-Inferiority of Various GSK Bio's Influenza Vaccine Presentations in Adults Aged 65 Years and Over. The trial enrolled 1,596 participants in Denmark, Estonia, and Norway and was randomized, double-blind, and active-controlled.