Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
C. difficile toxoid vaccine · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Placebo Vaccine Group | PLACEBO_COMPARATOR | Participants will receive a dose of vaccine diluent (placebo) on Days 0, 28 and 56, respectively. |
| Low Dose Vaccine Group | EXPERIMENTAL | Participants will receive a dose of vaccine containing of 2 µg Clostridium Difficile toxoid on Days 0, 28 and 56, respectively. |
| Medium dose vaccine group | EXPERIMENTAL | Participants will receive a dose of vaccine containing of 10 µg Clostridium Difficile toxoid on Days 0, 28 and 56, respectively. |
| High dose vaccine group | EXPERIMENTAL | Participants will receive a dose of vaccine containing of 50 µg Clostridium Difficile toxoid on Days 0, 28 and 56, respectively. |
| Name | Type | Description |
|---|---|---|
| Vaccine diluent buffer (Placebo) | BIOLOGICAL | 0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively. |
| C. difficile toxoid vaccine (2 µg) | BIOLOGICAL | 0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively. |
| C. difficile toxoid vaccine (10 µg) | BIOLOGICAL | 0.5 mL, Intramuscular on Day 0, Day 28 and Day 56, respectively. |
| C. difficile toxoid vaccine (50 µg) | BIOLOGICAL | 0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively. |
Inclusion Criteria: * Adult males or females, \> or = 65 years * In good general health * Clinical lab tests within normal range * Females must be post-menopausal * Able and willing to participate for duration of study and must not participate in any other experimental study for at least 60 days af...
C. difficile toxoid vaccine is an investigational vaccine being studied to prevent Clostridium difficile infections. It is designed to prompt an immune response against the toxins produced by C. difficile bacteria. The vaccine has been tested in healthy elderly volunteers aged 65 and older in the United States.
C. difficile toxoid vaccine is being developed by Sanofi, which trades under the ticker SNY. Sanofi conducted a Phase 1 clinical trial of the vaccine in healthy elderly volunteers to evaluate its safety, tolerability, and immunogenicity.
C. difficile toxoid vaccine is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by the FDA. The Phase 1 trial has been completed, and no active trials are currently listed.
C. difficile toxoid vaccine has been studied in one completed Phase 1 clinical trial, NCT00214461, titled Safety, Tolerability, and Immunogenicity of a Clostridium Difficile Toxoid Vaccine in Healthy Elderly Volunteers. The trial enrolled 48 participants in the United States, was randomized, double-blind, and placebo-controlled.