Pfizer C4771002

Purpose of this Study

We are doing this study to evaluate an experimental vaccine that is being developed to protect against C. diff infections. We want to find out if the study vaccine is effective for people who are at an increased risk for C. diff. We will look at how well the study vaccine can prevent infections and/or lower the severity of infections.

Who Can Participate?

Eligibility

Adults ages 65+ who have an increased risk of C. diff infection. People are considered to be at higher risk if they meet at least 1 of the following risk factors:
  • Have used antibiotics in the past 12 weeks; OR
  • Have made 2 visits to the ER in the past year; OR
  • Have spent at least 2 consecutive in nights in the hospital in the past year; OR
  • Have made 10 or more outpatient visits for medical care in the past year; OR
  • Have plans to spend at least 2 consecutive nights in the hospital, or have an upcoming surgery scheduled
We cannot enroll anyone into this study if they have been diagnosed with C. diff at any time in the past. For more information about who can join this study, contact the study team at dvtustudies@duke.edu or 919-971-5649.

Age Range

65-110

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
Yes

What is Involved?

Description

If you choose to join this study, you will:
  • Get a random assignment (50:50 chance) to either get the study vaccine or placebo (inactive substance with no drug in it)
  • Visit the study clinic 3 times in the first 7 months of the study to get the vaccine or placebo and have check-ups
  • Fill out health surveys on a phone app
Participation in the study will last for up to 3.5 years. In addition to the visits listed above, participants will also come in once per year for follow-up visits while they are active in the study. You can let us know if you are interested by filling out an interest form online: https://duke.qualtrics.com/jfe/form/SV_5gOo2FTJFHZvWia

Locations

Duke Raleigh Hospital
Other

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

Study Details

Full Title

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.

Study Website

Study Website

Principal Investigator

Emmanuel
Walter

Protocol Number

PRO00118801

Phase

III

Enrollment Status

Open to Enrollment