Learn more about Pfizer’s clinical trial for a vaccine that may help protect against C. difficile, a leading cause of healthcare-related infectious diarrhea.
C. difficile (C. diff) is a contagious bacteria that infects the colon (large intestine) and can cause diarrhea, abdominal pain, fever and other health complications. Development of a vaccine that helps the body’s immune system defend against C. diff could help protect those at greatest risk.
The BEETHOVEN study will help us learn if an investigational vaccine is safe and can help prevent C. diff infection in people 65 years of age or older.
Who may participate
Joining a clinical trial is an important and personal decision. Thank you for considering participation.
This clinical trial may be an option if you have not previously have not previously had C. diff and have one of the following risk factors for infection:
- Have received antibiotics in the last 3 months
- Have had 10 or more healthcare visits in the last year
- Have been hospitalized at least once or had 2 emergency room visits in the last year
- Are scheduled to be hospitalized or have elective surgery
There are other requirements for taking part in this clinical trial. The study team will explain these to you if you’d like to learn more. To see if you may qualify to participate, click “Get Started.”
Condition
C. difficile infection
Age
65+ years
Medical History
Have at least one risk factor for C. diff infection
Each clinical trial has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.
What to expect
If this clinical trial is a good fit for you and you agree to take part, here is what you can expect:
- You will be assigned by chance (like flipping a coin) to receive 2 doses of the investigational C. diff vaccine or placebo (injection with no vaccine) given about 6 months part.
- Participation may last for up to 3 and a half years. In the first 18 months, you will have at least 3 in-person visits and 3 phone calls. You will then have one annual visit until the study ends.
- You will be closely monitored for C. diff infection. If you have 3 or more episodes of diarrhea in 24 hours while you are in the study, you will need to provide a stool sample and will be asked to attend extra study visits.
- There is no cost to be in this study, and health insurance is not needed to participate. You will also be paid for completing some study-related activities.
Number of vaccine doses
2 doses
Visit schedule
At least 8 study visits over about 3 and a half
Study-related costs
No cost to participate, and you will be paid for completing study related activities
Watch a short video to learn more about C. diff
Your participation matters
Your participation matters
Participation by people of all backgrounds is critical to developing vaccines that protect against infectious diseases like C. diff. The greater the representation among clinical trial participants, the more we can learn about potential vaccines and how they work for different people, including those most at-risk. Each new vaccine breakthrough helps us reach more people to prevent and reduce the spread of disease.
Frequently asked questions
No, neither you nor the study doctor will know which vaccine you have received. The person giving the injections will know but will not be able to talk about it with you.
The study vaccine and study-related procedures will be provided at no cost. You will also be paid for completing study-related activities.
Participating in a clinical trial is completely voluntary (your choice). You can choose to leave the study at any time, for any reason, without penalty to you. If you decide not to participate, your future medical care will not be affected.
As with any vaccine, local reactions at the injection site can be common – such as redness, swelling, or pain. There is also potential for other symptoms like a mild fever or fatigue. The known side effects will be further explained in the Informed Consent Document (ICD) and discussed with you by the study doctor before you join the clinical trial. If we learn any new information about the study vaccine during the clinical trial, the study doctor will share that with you as well.
At the beginning of the clinical trial, the study doctor will ask you about your medical history including previous vaccinations and any medications you are currently taking. You will be given an electronic diary to report any episodes of diarrhea. If you experience 3 or more episodes of diarrhea within 24 hours, you will be asked to collect a stool sample and complete visits to find out information about the diarrhea illness. You may also have your blood drawn twice during the clinical trial. The study team will give you more information about the tests and procedures during the review of the Informed Consent Document (ICD).
