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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 ...
GSK3206641A is an investigational vaccine being studied for the prevention of influenza. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The vaccine is designed to be administered to adults aged 18 to 64 years.
GSK3206641A is being developed by GSK plc, a global biopharmaceutical company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in adults.
GSK3206641A is in Phase 1 clinical development. It is an investigational vaccine and has not yet received regulatory approval. The Phase 1 trial has been completed, and the vaccine remains under evaluation for its safety and immune response in humans.
GSK3206641A has been studied in one completed Phase 1 clinical trial, identified as NCT01999842. This randomized, double-blind, placebo-controlled trial enrolled 424 healthy adults aged 18 to 64 years in the United States and Canada to assess the vaccine's immunogenicity and safety.
GSK3206641A and GSK3206640A are two distinct investigational influenza vaccines developed by GSK. They were both evaluated in the same Phase 1 clinical trial (NCT01999842), which compared their safety and immunogenicity in adults aged 18 to 64 years.