jRCT2031260066
Recruiting
Not Applicable
A PHASE 3, PLACEBO-CONTROLLED, DOUBLE-BLINDED, RANDOMIZED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF A CLOSTRIDIOIDES DIFFICILE VACCINE IN ADULTS 65 YEARS OF AGE AND OLDER (BEETHOVEN)
Not provided0 sites32,000 target enrollmentStarted: TBD
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 32,000
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
Eligibility Criteria
- Ages
- 65age old over to No limit (—)
- Sex
- All
Inclusion Criteria
- •Who Can Join the Study (Inclusion Criteria):
- •People with recent or future planned contact with healthcare systems or who have recently received antibiotics.
Exclusion Criteria
- •Who Cannot Join the Study (Exclusion Criteria):
- •Anyone who has had CDI before.
- •Anyone who has had surgery to remove part of their small or large intestine.
- •Anyone who often has diarrhea (meaning three or more loose stools in a day, more than once a month).
- •Anyone who has already received a vaccine or special antibody treatment for C. difficile.
- •Anyone who has had a serious allergic reaction to a vaccine or to any part of the study vaccines.
- •Anyone who might not respond well to the vaccine because their immune system is weak (either from a disease or from treatment).
- •Anyone with cancer that has spread, kidney failure, or another serious health problem.
Investigators
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