C-Diffense

Efficacy, Immunogenicity, and Safety Study of Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection

C-Diffense [NCT01887912]

Description: The aim of this study is to evaluate the efficacy of the candidate Clostridium difficile (C. difficile) vaccine to prevent primary symptomatic C. difficile infection (CDI) in subjects a risk for CDI where there is a substantial unmet medical need.

 

Biological: C. difficile Toxoid Vaccine; Biological: Placebo: 0.9% normal saline

Primary Investigator: Kereiakes

Drug/Device Information
To assess the efficacy of the C. difficile vaccine in preventing the onset of symptomatic primary CDI confirmed by PCR
Adult subjects aged ≥ 50 years who are at risk for CDI and have received at least 1 injection
Bivalent toxoid C. difficile vaccine
Randomization 2:1 between vaccine and placebo groups
Sanofi Pasteur