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Investigational H7N9 vaccine GSK3206641A · 1 trial · 1 indication
The following aggregate variables will be calculated for each adjuvanted H7N9 vaccine group: • Seroconversion rates (SCR); • Seroprotection rates (SPR); • Mean Geometric Increase (MGI)
| Arm | Type | Description |
|---|---|---|
| Formulation 1 Group | EXPERIMENTAL | Subjects in this group will receive two doses of GSK3206641A H7N9 vaccine formulation 1 at a 21 day interval |
| Formulation 2 Group | EXPERIMENTAL | Subjects in this group will receive two doses of GSK3206641A H7N9 vaccine formulation 2 at a 21 day interval |
| Formulation 3 Group | EXPERIMENTAL | Subjects in this group will receive two doses of GSK3206641A H7N9 vaccine formulation 3 at a 21 day interval |
| Formulation 4 Group | EXPERIMENTAL | Subjects in this group will receive two doses of GSK3206641A H7N9 vaccine formulation 4 at a 21 day interval |
| Formulation 5 Group | EXPERIMENTAL | Subjects in this group will receive two doses of GSK3206640A H7N9 vaccine formulation 5 at a 21 day interval |
| Placebo Group | PLACEBO_COMPARATOR | Subjects in this group will receive two doses of placebo at a 21 day interval |
| Name | Type | Description |
|---|---|---|
| Investigational H7N9 vaccine GSK3206641A | BIOLOGICAL | One dose of GSK3206641A H7N9 vaccine administered intramuscularly (IM) in the deltoid region of arm at Day 0 and the second dose of GSK3206641A H7N9 vaccine administered IM in the deltoid region of arm at Day 21 |
| Investigational H7N9 vaccine GSK3206640A | BIOLOGICAL | One dose of GSK3206640A H7N9 vaccine administered IM at the deltoid region of arm at Day 0 and the second dose of GSK3206640A H7N9 vaccine administered IM at the deltoid region of arm at Day 21 |
| Placebo | BIOLOGICAL | One dose of placebo administered IM at the deltoid region of arm at Day 0 and the second dose of placebo administered IM at the deltoid region of arm at Day 21 |
Inclusion Criteria: * Male or female adults who are 18 to 64 years of age (inclusive) at the time of first study vaccination. * Written informed consent obtained from subject. * Subjects who the investigator believes can and will comply with the requirements of the protocol . * Healthy subjects as ...
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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 |
| Sinovac Biotech Ltd. | SVA | 1 | PHASE3 | Quadrivalent influenza vaccine (split virion), inactivated |
| 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 |
The investigational H7N9 vaccine GSK3206641A is a Phase 1 vaccine candidate developed by GSK plc for influenza. It is designed to address the H7N9 influenza strain and was evaluated in a completed clinical study of 424 healthy adults aged 18 to 64 years in the United States and Canada.
GSK plc, which trades under the ticker GSK, is the developer of the investigational H7N9 vaccine GSK3206641A. The company sponsored the Phase 1 study of the vaccine candidate in healthy adult volunteers.
The investigational H7N9 vaccine GSK3206641A is in Phase 1 development. Its single clinical trial, NCT01999842, has been completed, and no active trials are currently listed for this vaccine candidate.
The investigational H7N9 vaccine GSK3206641A was studied in one completed Phase 1 trial, NCT01999842, titled an immunogenicity and safety study of GSK Biologicals' influenza vaccines GSK3206641A and GSK3206640A in adults 18 to 64 years of age. It enrolled 424 participants in the United States and Canada.
The Phase 1 trial of the investigational H7N9 vaccine GSK3206641A, NCT01999842, was a randomized, double-blind, placebo-controlled study. It enrolled 424 healthy volunteers aged 18 to 64 years of all sexes across sites in the United States and Canada, and the trial has been completed.
The investigational H7N9 vaccine GSK3206641A is being developed for influenza, specifically for the H7N9 influenza strain. It is a vaccine candidate studied in healthy adult volunteers aged 18 to 64 years as part of a Phase 1 immunogenicity and safety trial.