Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Influenza investigational vaccine GSK2340274A · 1 trial · 1 indication
Titers are presented as geometric mean titers (GMTs).
A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10.
A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer smaller than (\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0.
| Arm | Type | Description |
|---|---|---|
| GSK2340274A GROUP | EXPERIMENTAL | Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. |
| Name | Type | Description |
|---|---|---|
| Influenza investigational vaccine GSK2340274A | BIOLOGICAL | Two intramuscular injections on Day 0 and Day 21, respectively |
Inclusion Criteria: * Japanese male and female adults 20 to 64 years of age at time of the first vaccination, inclusive. * Good general health as assessed by medical history and physical examination * Subjects who the investigator believes that they can and will comply with the requirements of the ...
GSK2340274A is an investigational influenza vaccine being developed for the prevention of influenza. It is designed to elicit an immune response against the H1N1 strain of the virus. The vaccine is currently in clinical development and has not been approved for use.
GSK2340274A is being developed by GSK plc, a global biopharmaceutical company. GSK plc is listed on the stock exchange under the ticker symbol GSK. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity.
GSK2340274A is in Phase 2 clinical development. It is an investigational vaccine, meaning it has not yet been approved by regulatory authorities. The vaccine is being studied for its ability to generate an immune response against influenza and to assess its safety profile.
GSK2340274A has been evaluated in one completed Phase 2 clinical trial, identified as NCT00989612. This study, titled 'Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1),' enrolled 100 healthy volunteers in Japan. The trial was uncontrolled and not randomized or double-blinded.
GSK2340274A is an investigational vaccine specifically targeting the H1N1 influenza strain. While it is designed to protect against H1N1, it is not a licensed H1N1 vaccine. It is still in clinical development, and its efficacy and safety have not been fully established.