NCT07282665

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 32,000 (estimated)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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 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 clinical 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.

Conditions

• Clostridioides Difficile Associated Disease

Interventions

Type	Name	Description
BIOLOGICAL	C.difficile vaccine	C.difficile vaccine given as an intramuscular injection
OTHER	Saline Placebo	0.9% sodium chloride solution given as a intramuscular injection

Timeline

• Start date: 2025-12-10
• Primary completion: 2028-12-11
• Completion: 2029-06-07
• First posted: 2025-12-15
• Last updated: 2026-02-27

Locations

129 sites across 3 countries: United States, Argentina, United Kingdom

Regulatory

• FDA-regulated drug study