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Clostridium difficile vaccine · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants will receive a dose of vaccine diluent (placebo) on Days 0, 28, and 56, respectively. |
| Low dose vaccine | EXPERIMENTAL | Participants will receive a 2 μg dose of C. difficile toxoid vaccine on Days 0, 28, and 56, respectively. |
| Medium dose vaccine | EXPERIMENTAL | Participants will receive a 10 μg dose of C. difficile toxoid vaccine on Days 0, 28, and 56, respectively |
| High dose vaccine | EXPERIMENTAL | Participants will receive a 50 μg dose of C. difficile toxoid vaccine on Days 0, 28, and 56, respectively |
| Name | Type | Description |
|---|---|---|
| Placebo (vaccine diluent) | BIOLOGICAL | 0.5 mL, intramuscular (IM) on Days 0, 28, and 56, respectively. |
| Clostridium difficile vaccine | BIOLOGICAL | 0.5 mL, intramuscular on Days 0, 28, and 56, respectively. |
Inclusion Criteria: * Adult males or females, 18-55 years (inclusive) * In good general health * Clinical lab tests within normal range * Non-pregnant female subjects * Able and willing to participate for duration of study and must not participate in any other experimental study for at least 60 day...
Clostridium difficile vaccine is an investigational monoclonal antibody being developed by Sanofi for the prevention of Clostridium difficile infections. It is designed to target the toxins produced by the bacterium, which cause diarrhea and colitis. The vaccine is currently in Phase 1 clinical development and is not yet approved for use.
Clostridium difficile vaccine targets the toxins produced by Clostridium difficile bacteria. By eliciting an immune response against these toxins, the vaccine aims to prevent the symptoms of C. difficile infection, including diarrhea and inflammation of the colon. This mechanism is intended to provide protection against the disease.
Clostridium difficile vaccine is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the safety and immunogenicity of this investigational vaccine for the prevention of Clostridium difficile infections.
Clostridium difficile vaccine is in Phase 1 clinical development. It is an investigational product and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the vaccine is still in the early stages of clinical testing to assess its safety and immune response in healthy volunteers.
Clostridium difficile vaccine has one completed Phase 1 clinical trial registered under NCT00127803. The study, titled 'Safety, Tolerability, and Immunogenicity Study of a Clostridium Difficile Toxoid Vaccine in Healthy Adult Volunteers,' enrolled 50 participants and was a randomized, double-blind, placebo-controlled trial. The trial has been completed.
Clostridium difficile vaccine is being studied as a toxoid vaccine, as indicated by the clinical trial title referencing a 'Clostridium Difficile Toxoid Vaccine.' The vaccine is designed to elicit an immune response against the toxins produced by the bacterium, which are responsible for the symptoms of infection.