Status:
RECRUITING
A Study to Learn About a Clostridioides Difficile Vaccine in People 65 Years of Age and Older
Lead Sponsor:
Pfizer
Conditions:
Clostridioides Difficile Associated Disease
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to learn about how effective, safe, and tolerable the Clostridioides difficile (C. difficile) vaccine is in decreasing the number of C. difficile infections (pCDI) in adult...
Eligibility Criteria
Inclusion
- Who Can Join the Study (Inclusion Criteria):
- • People with recent or future planned contact with healthcare systems or who have recently received antibiotics.
Exclusion
- ):
- 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.
Key Trial Info
Start Date :
December 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 7 2029
Estimated Enrollment :
32000 Patients enrolled
Trial Details
Trial ID
NCT07282665
Start Date
December 10 2025
End Date
June 7 2029
Last Update
February 27 2026
Active Locations (129)
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1
North Alabama Research Center
Athens, Alabama, United States, 35611
2
Lakeview Clinical Research
Guntersville, Alabama, United States, 35976
3
Medical Affiliated Research Center
Huntsville, Alabama, United States, 35801
4
Epic Medical Research-Sun City
Sun City, Arizona, United States, 85351