A Study to Learn About a Clostridioides Difficile Vaccine in People 65 Years of Age and Older (NCT07282665)
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
🩺 Plain-English Summary (8th-Grade Level)
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 for up to about three and a half years. During this time, participants will have 3 planned clinic visits and 3 planned phone visits. After these visits, more scheduled clinic visits will happen every year until the end of study. Besides the scheduled study visits, if at any time during the study a participant has 3 or more loose stools in 24 hours, they will be asked to save the next one (the fourth or later) and contact the study site. The study site will check to see if it could be a C. difficile infection. This check may happen at the clinic or through a phone or video call.
Who can join: Review the eligibility criteria below.
Location: North Alabama Research Center — Athens, Alabama
Age range: 65 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (183 Sites)
Showing the first 25 of 183 sites.
- North Alabama Research Center — Athens, Alabama
- Lakeview Clinical Research — Guntersville, Alabama
- Medical Affiliated Research Center — Huntsville, Alabama
- Chinle Center for Indigenous Health — Chinle, Arizona
- Chinle Comprehensive Health Care Facility — Chinle, Arizona
- Epic Medical Research-Sun City — Sun City, Arizona
- Applied Research Center of Arkansas — Little Rock, Arkansas
- Kaiser Permanente Daly City — Daly City, California
- Kaiser Permanente Los Angeles Medical Center — Los Angeles, California
- Kaiser Permanente Oncology Pharmacy #014C — Los Angeles, California
- Sacramento VA Medical Center — Mather, California
- Kaiser Permanente Oakland — Oakland, California
- Kaiser Permanente Ontario Medical Center — Ontario, California
- Kaiser Permanente Roseville — Roseville, California
- Kaiser Permanente Sacramento — Sacramento, California
- Kaiser Permanente South Sacramento — Sacramento, California
- Velocity Clinical Research, San Bernardino — San Bernardino, California
- Kaiser Permanente - San Diego Medical Center — San Diego, California
- Kaiser Permanente Viewridge Medical Office — San Diego, California
- Kaiser Permanente San Jose — San Jose, California
- Carbon Health - San Mateo - Hillsdale Mall — San Mateo, California
- Kaiser Permanente Santa Clara — Santa Clara, California
- Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc. — Toluca Lake, California
- Kaiser Permanente Walnut Creek — Walnut Creek, California
- Diablo Clinical Research, Inc. — Walnut Creek, California
📞 Contact the Study Coordinator
Phone: (800) 718-1021
Email: ClinicalTrials.gov_Inquiries@pfizer.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.