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GlaxoSmithKline Biologicals' influenza vaccine GSK576389A · 1 trial · 1 indication
Antibody titers were expressed as Geometric mean titers (GMTs) against each of the 3 vaccine strains in greater than or equal to 65 years age groups only. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
| Arm | Type | Description |
|---|---|---|
| Influenza vaccine GSK576389A formulation 1 Group | EXPERIMENTAL | Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A. |
| Influenza vaccine GSK576389A formulation 2 Group | EXPERIMENTAL | Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A. |
| Influenza vaccine GSK576389A formulation 3 Group | EXPERIMENTAL | Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A. |
| Influenza vaccine GSK576389A formulation 4 Group | EXPERIMENTAL | Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A. |
| Influenza vaccine GSK576389A formulation 5 Group | EXPERIMENTAL | Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A. |
| Influenza vaccine GSK576389A formulation 6 Group | EXPERIMENTAL | Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A. |
| Influenza vaccine GSK576389A formulation 7 Group | EXPERIMENTAL | Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A. |
| Influenza vaccine GSK576389A formulation 8 Group | EXPERIMENTAL | Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A. |
| Fluarix elderly Group | ACTIVE_COMPARATOR | Subjects aged ≥65 years received one dose of Fluarix vaccine. |
| Fluarix young Group | ACTIVE_COMPARATOR | Subjects aged 18-40 years received one dose of Fluarix vaccine. |
| Name | Type | Description |
|---|---|---|
| GlaxoSmithKline Biologicals' influenza vaccine GSK576389A | BIOLOGICAL | Single dose, Intramuscular injection, 8 different formulations were tested (one per group) |
| Fluarix | BIOLOGICAL | Single dose, Intramuscular injection |
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 18-40 years old or 65 years or older at the time of the vaccination. * Written informed consent obtained from the...
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| 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 |
GSK576389A is an investigational influenza vaccine developed by GlaxoSmithKline Biologicals, part of GSK plc. It is a vaccine candidate intended for the prevention of influenza in adults. It has been studied in a Phase 2 clinical trial and is not an approved product.
GSK576389A is being developed for the prevention of influenza. Its clinical program evaluated the vaccine in healthy adult volunteers aged 18 years and older. The indication studied was influenza, and the trial assessed immunogenicity and safety of different formulations of the vaccine.
GSK576389A is made by GlaxoSmithKline Biologicals, the vaccine division of GSK plc, which trades on the New York Stock Exchange under the ticker GSK. GSK is the developer and sponsor of the vaccine candidate.
GSK576389A is in Phase 2 development. One Phase 2 trial has been completed, and no active trials are currently listed. The vaccine is investigational and has not been approved by the FDA or any other regulatory authority based on the available information.
GSK576389A has been studied in one completed Phase 2 trial, NCT00540592, titled an immunogenicity and safety study to evaluate different formulations of GSK Biologicals' influenza vaccine GSK576389A. The trial enrolled 2,007 participants across Germany, the Netherlands, Sweden, and the United Kingdom.
The Phase 2 trial NCT00540592 was a randomized, double-blind, active-controlled study. It enrolled 2,007 healthy adult volunteers aged 18 years and older of all sexes. The study evaluated immunogenicity and safety of different formulations of the vaccine and was conducted in Germany, the Netherlands, Sweden, and the United Kingdom.