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

Conditions

• Clostridioides Difficile Associated Disease

Eligibility Criteria

Sex

ALL

Age

65 Years - N/A

Healthy Volunteers

Accepted

Interventions

• C.difficile vaccine — BIOLOGICAL
  C.difficile vaccine given as an intramuscular injection
• Saline Placebo — OTHER
  0.9% sodium chloride solution given as a intramuscular injection

Study Details

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.

Key Dates

Start date

Dec 10, 2025

Status verified

May 2026

Primary completion

Dec 11, 2028

Completion

Jun 7, 2029

Study Design

Enrollment

32,000 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: C.difficile vaccine
  Novel vaccine formulation
• Other: Saline Placebo

Primary Outcome Measure

The percentage of participants reporting local reactions [ Time Frame: For 7 days after each vaccination ]

Central Contacts

• Pfizer CT.gov Call Center
  1-800-718-1021
  [email protected]

Locations (135)

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