Phase III Study of Investigational Vaccine in Canada to Prevent Clostridium difficile

Sanofi Pasteur, the vaccines division of Sanofi 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 infection (CDI). Clostridium difficile (C. diff) is a potentially life-threatening, spore-forming bacterium that causes intestinal disease. The risk of C. diff increases with age, antibiotic treatment and time spent in hospitals or nursing homes, where multiple cases can lead to outbreaks. The investigational C. diff vaccine is designed to produce an immune response that targets the toxins generated by C. diff bacteria, which can cause inflammation of the gut and lead to diarrhea. The investigational vaccine stimulates a person’s immune system to fight C. diff toxins upon exposure and ultimately may help prevent a future infection from occurring. The Cdiffense Phase III clinical program has just started recruiting volunteers in Canada 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. For more information on the Cdiffense trial, please visit www.Cdiffense.org.