Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
The Clostridium difficile vaccine is an investigational toxoid vaccine developed by Sanofi for the prevention of Clostridium Infections. It is designed to stimulate an immune response against Clostridium difficile and is being studied in healthy adult volunteers. It remains in clinical development and is not approved for use.
The Clostridium difficile vaccine is being developed for the prevention of Clostridium Infections, which are caused by the bacterium Clostridium difficile. The vaccine is intended to protect against infection by generating an immune response. It is investigational and has not been approved for any indication.
The Clostridium difficile vaccine is developed by Sanofi, which trades on the New York Stock Exchange under the ticker SNY. Sanofi is the sponsor of the clinical program evaluating the vaccine in healthy adult volunteers.
The Clostridium difficile vaccine is in Phase 1 clinical development. One Phase 1 trial has been completed, and there are no active trials. The vaccine is investigational and has not been approved by the FDA or any regulatory authority.
The Clostridium difficile vaccine has been studied in one completed Phase 1 trial, NCT00127803, titled Safety, Tolerability, and Immunogenicity Study of a Clostridium Difficile Toxoid Vaccine in Healthy Adult Volunteers. The trial enrolled 50 healthy adult volunteers aged 18 years and older and was randomized, double-blind, and placebo-controlled.