This is a phase 3, placebo-controlled, randomized study to evaluate the efficacy, safety and tolerability of a vaccine for clostridium difficile in adults 60 years of age and older. Enrollment is now limited to adults 60 years of age and older.
The purpose of this study is to find out if an investigational vaccine prevents severe diarrhea caused by a germ (bacterium) called Clostridium difficile (C diff).
C diff is a significant cause of infectious diarrhea. Its severity can range from being mild to severe, and can lead to death. Most people who get C diff diarrhea are older and have hospital stays, see their doctor often, live in a nursing home or take antibiotics. In this study, you will receive 3 injections over a period of 6 months, either the investigational C diff vaccine or a placebo. To find out whether the vaccine prevents C diff diarrhea, we will closely monitor you for signs of infection for up to 3 years after you receive your last vaccine.
Across the World, around 16,000 people in around 25 countries will take part in this study.
All study procedures and medication is provided to you at no cost and financial compensated is available for your time and travel to the study site.
All information you provide is stored in a secure site, and cannot be released to any third party without your written and signed authorization.
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