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A Study to Learn About a Clostridioides Difficile Vaccine in People 65 Years of Age and Older

RecruitingPhase 3Ages 65 Years - anyAllPfizer
NCT07282665 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 does not work. Participants will stay in the study until enough events have occurred to answer the main question. On average, each person is expected to take part f

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📋 Eligibility rules (as published)
Who Can Join the Study (Inclusion Criteria): • People with recent or future planned contact with healthcare systems, recent antibiotic exposure, or a diagnosis of certain chronic medical conditions. 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 or another serious health problem.
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What it tests

  • C.difficile vaccine
  • Saline Placebo
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Where

186 sites
North Alabama Research Center
Athens, United States
Lakeview Clinical Research
Guntersville, United States
Medical Affiliated Research Center
Huntsville, United States
Chinle Center for Indigenous Health
Chinle, United States
Chinle Comprehensive Health Care Facility
Chinle, United States
Epic Medical Research-Sun City
Sun City, United States
Applied Research Center of Arkansas
Little Rock, United States
Kaiser Permanente Daly City
Daly City, United States

…and 178 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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