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DJ19- Pfizer C-Diff Vaccine - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if an investigational vaccine prevents severe diarrhea caused by a germ called Clostridium difficile (C diff).

What is the Condition Being Studied?

c. Diff vaccine for older adults

Who Can Participate in the Study?

Adults over 50 who have with an increased risk of future contact with healthcare systems, for example:
- Have received antibiotics in the past 12 weeks
- Have made at least 10 outpatient medical visits in the past year
- Have been hospitalized for at least 2 nights in the past year
- Live in a nursing facility
- Have had 2 emergency room visits in the past year

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Be randomized (like the flip of a coin) to receive
-- 3 doses of an investigational vaccine for the germ Clostridium difficile or
-- 3 doses of a placebo (an inactive substance).
- Return for 5 outpatient visits to the Duke Early Phase Clinical Research Unit  over the course of 7 months., with a follow-up period for up to 3.5 years.
Blood will be drawn 3 times over the 7 months.
Additional blood and stool samples may be necessary if you experience diarrhea.

Study Details

Full Title
A Phase 3, Placebo-Controlled, Randomized, Observer-Blinded Study to Evaluate the Efficacy, Safety, and Tolerability of a Clostridium Difficile Vaccine in Adults 50 Years of Age and Older.
Principal Investigator
Protocol Number
IRB:PRO00082496
NCT:NCT03090191
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698