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 developed for the prevention of Clostridium infections, specifically infections caused by Clostridium difficile. It is designed to generate an immune response against the toxins produced by the bacteria. The vaccine is currently in Phase 1 clinical development and is not yet approved for use.
C. 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 trials to evaluate the safety and immunogenicity of the vaccine in healthy elderly volunteers.
C. difficile toxoid vaccine is in Phase 1 clinical development. A Phase 1 trial has been completed, which assessed the safety, tolerability, and immunogenicity of the vaccine in healthy elderly volunteers. The vaccine is investigational and has not received regulatory approval.
C. difficile toxoid vaccine has one completed clinical trial registered under NCT00214461. This Phase 1 study evaluated the safety, tolerability, and immunogenicity of the vaccine in healthy elderly volunteers aged 65 years and older in the United States. The trial enrolled 48 participants and was randomized, double-blind, and placebo-controlled.
No, C. difficile toxoid vaccine is not a monoclonal antibody. Although the drug is classified under the modality of monoclonal antibody in some databases, it is actually a vaccine designed to stimulate the immune system to produce antibodies against Clostridium difficile toxins. The vaccine is administered to prevent infection, rather than as a therapeutic antibody.