Sanofi initiates Phase III studies for C.Difficile vaccine

Sanofi Pasteur, has announced the initiation of its Phase III clinical program called Cdiffense to evaluate the safety, immunogenicity and efficacy of an investigational vaccine for the prevention of primary symptomatic Clostridium difficile. The Cdiffense Phase III clinical program has just started recruiting volunteers for a randomized, observer-blind, placebo-controlled, multi-center, multi-national trial that will include up to 15,000 adults at 200 sites across 17 countries. Volunteers for the study should be age 50 or older and planning an upcoming hospitalization or have had at least two hospital stays and have received systemic antibiotics in the past year.