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

  • STATUS
    Recruiting
  • End date
    Jun 7, 2029
  • participants needed
    32000
  • sponsor
    Pfizer
Send
Updated on 30 June 2026
See if I qualify
Accepts healthy volunteers

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.

Details
Condition Clostridioides Difficile Associated Disease
Age 65years or above
Clinical Study IdentifierNCT07282665
SponsorPfizer
Last Modified on30 June 2026

Eligibility

 Yes No Not Sure

Inclusion Criteria

• People with recent or future planned contact with healthcare systems or who
have recently received antibiotics

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 another serious health problem
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Email

View email

Phone

Phone country flag

View phone
Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

Accepts healthy volunteers

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.