Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK2340272A · 1 trial · 1 indication
Seroconversion was defined as: For initially seronegative subjects \[antibody titer below (\<) 10 post-vaccination\], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection.
GMFR was defined as the fold change in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.
| Arm | Type | Description |
|---|---|---|
| GSK2340272A Group | EXPERIMENTAL | Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. |
| GSK2340269A Group | EXPERIMENTAL | Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. |
| Name | Type | Description |
|---|---|---|
| GSK2340272A | BIOLOGICAL | Two intramuscular injections in the deltoid region of the non-dominant arm. |
| GSK2340269A | BIOLOGICAL | Two intramuscular injections in the deltoid region of the non-dominant arm. |
Inclusion Criteria: * A male or female aged 18 to 60 years at the time of the first vaccination. * Subjects who the investigator believes that they can and will comply with the requirements of the protocol. * Written informed consent obtained from the subject. * Satisfactory baseline medical assess...
GSK2340272A is an investigational monoclonal antibody being developed for influenza, an infectious disease. It is currently in Phase 3 clinical development. The drug is being studied for its potential to address influenza, though it remains investigational and is not yet approved.
GSK2340272A is a monoclonal antibody, a type of biologic drug. Its specific molecular target has not been disclosed in available information. The drug is being studied for influenza, but the exact mechanism of action is not publicly detailed.
GSK2340272A 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 drug's safety and efficacy for influenza.
GSK2340272A is currently in Phase 3 clinical development for influenza. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 3 trial has been completed, but the drug remains under investigation.
GSK2340272A has one completed Phase 3 clinical trial, identified as NCT00989287. This study evaluated the immunogenicity and safety of an investigational influenza vaccine in adults. The trial enrolled 131 participants in Belgium and was randomized, double-blind, and controlled.