Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GSK3536852A vaccine
S.sonnei vaccine · 1 trial · 1 indication
Attack rate of shigellosis expressed as percentage of subjects with at least one episode of shigellosis after challenge, and 90% confidence interval (CI) (Clopper-Pearson method). Episodes of shigellosis fulfilling primary case definition: Shedding of S. sonnei 53G accompanied by moderate or severe diarrhea OR shedding with oral temperature greater than or equal to (≥) 38.5°C. Moderate diarrhea consists of 4 to 5 loose or watery (Grade \[G\]3 to 5) stools or 400 to 800 grams of G3 to 5 stools within 24 hours. Severe diarrhea consists of 6 or more loose or watery (G3 to 5) stools or \> 800 grams of G3 to 5 stools within 24 hours or required medical intervention. In case of severe diarrhea, medical intervention is defined as intravenous fluids administration or anticipation of antibiotic treatment before the 5th day after challenge. G3 = viscous opaque liquid or semi-liquid which assumes the shape of the bowl; G4 = watery opaque liquid; G5 = clear watery or mucoid liquid.
| Arm | Type | Description |
|---|---|---|
| S. sonnei Group | EXPERIMENTAL | Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the S. sonnei study vaccine at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally. |
| Placebo Group | PLACEBO_COMPARATOR | Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the placebo at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally. |
| Name | Type | Description |
|---|---|---|
| S.sonnei vaccine | BIOLOGICAL | Subjects receiving 2 doses of the study vaccine by intramuscular route, 28 days apart (at Day 1 and Day 29). |
| Placebo | DRUG | Subjects receiving 2 doses of placebo by intramuscular route, 28 days apart (at Day 1 and Day 29). |
| S. sonnei 53G challenge strain | BIOLOGICAL | Subjects receiving the challenge dose of S. sonnei 53G strain, orally, at Day 57. |
Inclusion Criteria: * Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Written informed consent obtained from the subject prior to performing any study specific procedure. * Individuals who, after the nature of the study has been explain...
The S.sonnei vaccine is being developed to protect against infection with Shigella sonnei, the bacterium that causes bacillary dysentery. It is intended for use in healthy adults. The vaccine is designed to prevent Shigella sonnei infection, which is a cause of diarrheal disease.
The S.sonnei vaccine is being developed by GSK plc, which trades under the ticker GSK. GSK is a global pharmaceutical company involved in the research and development of vaccines and medicines.
The S.sonnei vaccine is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by the FDA. The Phase 2 trial has been completed.
The S.sonnei vaccine has been studied in a Phase 2 clinical trial, NCT03527173, titled "A Study to Evaluate the Efficacy, Safety and Immunogenicity of a Vaccine Designed to Protect Against Infection With Shigella Sonnei in Healthy Adults." This trial was completed and enrolled 71 participants in the United States.
The S.sonnei vaccine is designed to stimulate the immune system to protect against infection with Shigella sonnei. It is a vaccine modality, and the trial evaluated its efficacy, safety, and immunogenicity in healthy adults.