The aim of this study is to evaluate the efficacy of the candidate Clostridium difficile
(Cdiffense) vaccine to prevent primary symptomatic C. difficile infection (CDI) in subjects
a risk for CDI where there is a substantial unmet medical need.
- To assess the efficacy of the C. difficile vaccine in preventing the onset of
symptomatic primary CDI confirmed by polymerase chain reaction (PCR) in adult subjects
aged ? 50 years who are at risk for CDI and have received at least 1 injection.
- To assess prevention of symptomatic PCR-confirmed primary CDI cases after 3 injections
administered at 0, 7, and 30 days
- To assess prevention of symptomatic PCR-confirmed primary CDI cases after completion of
at least 2 injections.
- To describe the immunogenicity to toxin A and toxin B in the subset of subjects at
specific time points.
- To describe the safety profile of all subjects who receive at least 1 injection.
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