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Clostridium difficile Toxoid Vaccine · 1 trial · 1 indication
Solicited injection site reactions: Pain, Redness, and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, and Arthralgia.
Serum antibody concentrations to toxins A and B will be measured by enzyme-linked immunosorbent assay (ELISA)
Serum antibody titers against toxins A and B will be measured by toxin neutralizing assay (TNA)
| Arm | Type | Description |
|---|---|---|
| Vaccine Group | EXPERIMENTAL | Participants will receive the candidate C. difficile toxoid vaccine |
| Placebo Group | PLACEBO_COMPARATOR | Participants will receive a placebo vaccine |
| Name | Type | Description |
|---|---|---|
| Clostridium difficile Toxoid Vaccine | BIOLOGICAL | 0.5 mL, intramuscular |
| 0.9% normal saline | BIOLOGICAL | 0.5 mL, intramuscular |
Inclusion Criteria: * Healthy adult subjects aged 40 to 75 years on the day of inclusion * Informed consent form has been signed and dated * Able to attend all scheduled visits and to comply with all trial procedures. Exclusion Criteria: * Subject is pregnant, or lactating, or of childbearing pot...
Clostridium difficile Toxoid Vaccine is an investigational vaccine being studied for the prevention of Clostridium difficile infection, a bacterial infection that can cause severe diarrhea and colitis. It is being developed for use in adults, with a clinical trial conducted in healthy subjects aged 40 to 75 years.
Clostridium difficile Toxoid Vaccine is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. The company is conducting clinical research to evaluate the vaccine's safety and immunogenicity in preventing Clostridium difficile infection.
Clostridium difficile Toxoid Vaccine is in Phase 1 clinical development. It is an investigational vaccine, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and potential efficacy in preventing Clostridium difficile infection.
Clostridium difficile Toxoid Vaccine has been studied in one completed Phase 1 clinical trial, identified as NCT01896830. This trial, titled 'Study of a Candidate Clostridium Difficile Toxoid Vaccine in Healthy Adult Subjects Aged 40 to 75 Years in Japan,' enrolled 102 participants and was conducted in Japan.
Clostridium difficile Toxoid Vaccine is classified as a monoclonal antibody modality, though it is being developed as a vaccine to prevent Clostridium difficile infection. The clinical trial for this candidate was placebo-controlled and randomized, but it was not double-blinded, and it involved healthy volunteers.