A Study to Learn About a Clostridioides Difficile Vaccine in People 65 Years of Age and Ol
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 adults 65 years of age or older. The participants will receive either the C. difficile vaccine or placebo (saline). A placebo
| Condition(s) | Clostridioides Difficile Associated Disease |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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 adults 65 years of age or older. The participants will receive either the C. difficile vaccine or placebo (saline). A placebo does not contain any active ingredients. The vaccines will be given as a shot into the upper arm muscle. This study looks at the number of diarrhea (loose stools) events related to a C. difficile infection, so the length of the study can change. If these events happen quickly, the study may finish sooner; if they happen slowly, it could take longer. Sometimes, the study might stop early if the vaccine clearly works or clearly doesn't. Participants will stay in the study unti |
| Who can participate | Who Can Join the Study (Inclusion Criteria): • People with recent or future planned contact with healthcare systems or who have recently received antibiotics. 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 |
| Ages | 65 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Pfizer |
| Locations | Athens, Alabama, United States; Guntersville, Alabama, United States; Huntsville, Alabama, United States; Sun City, Arizona, United States; Little Rock, Arkansas, United States; Daly City, California, United States (+168 more sites) |
| Start date | 2025-12-10 |
| NCT ID | NCT07282665 |
| Official listing | https://clinicaltrials.gov/study/NCT07282665 |