Trials / Completed
CompletedNCT03090191
Clostridium Difficile Vaccine Efficacy Trial
A PHASE 3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF A CLOSTRIDIUM DIFFICILE VACCINE IN ADULTS 50 YEARS OF AGE AND OLDER
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 17,535 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Accepted
Summary
The Clover trial is evaluating an investigational vaccine that may help to prevent Clostridium difficile infection. Participants in the study are adults 50 years of age and older, who are at risk of developing Clostridium difficile infection. The study will assess whether the vaccine prevents the disease, and whether it is safe and well tolerated. Each subject will receive 3 doses of Clostridium difficile vaccine or placebo and be followed for up to 3 years after vaccination for potential Clostridium difficile infection.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Clostridium difficile vaccine | Toxoid-based Clostridium difficile vaccine |
| BIOLOGICAL | Placebo | Normal saline solution (0.9% sodium chloride) |
Timeline
- Start date
- 2017-03-29
- Primary completion
- 2021-12-21
- Completion
- 2021-12-21
- First posted
- 2017-03-24
- Last updated
- 2023-02-13
- Results posted
- 2023-02-13
Locations
426 sites across 23 countries: United States, Argentina, Australia, Belgium, Bulgaria, Canada, Chile, Colombia, Czechia, Finland, France, Germany, Hungary, Japan, Peru, Poland, Portugal, Slovakia, South Korea, Spain, Sweden, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03090191. Inclusion in this directory is not an endorsement.