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Sanofi Pasteur Starts a Phase II Study of a Vaccine Against Clostridium Difficile
Date:2/17/2009

LYON, France, February 17 /PRNewswire-FirstCall/ -- Sanofi Pasteur, the vaccines division of sanofi-aventis Group (EURONEXT : SAN and NYSE : SNY), announced today that it is sponsoring a phase II clinical study of a vaccine against Clostridium difficile, which is among the most common causes of hospital-acquired infection in Europe and North America.

The trial currently conducted in the United Kingdom is investigating the safety and efficacy of sanofi pasteur's C. difficile candidate vaccine. While the target indication for the vaccine is primary prevention of C. difficile infection (CDI), this trial in infected patients aims at providing early proof of concept of the vaccine approach.

"Treatment of C. difficile infection includes the use of one of two antibiotics. Non-antibiotic approaches for managing C. difficile infection are badly needed since the alteration of the gut flora associated with antibiotics triggers the infection in the first place. There is also considerable concern about the emergence of antibiotic-resistance in C. difficile and other bacteria. Vaccination has the potential to be a very effective strategy to combat gastrointestinal pathologies caused by C. diff. along with better antibiotic stewardship and infection control practices," said Barry Cookson, Director, Laboratory of Healthcare Associated Infections, Centre for Infections, Health Protection Agency and the lead investigator of the trial.

Sanofi Pasteur's candidate vaccine uses a toxoid-based approach, which has been used extensively in sanofi pasteur's licensed vaccines against tetanus, diphtheria and pertussis (whooping cough). This candidate vaccine has successfully completed phase I clinical trials in more than 200 participants to evaluate its safety and immunogenicity.

The incidence of CDI has increased significantly in recent years in both North America and Europe. CDI-related treatments in th
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SOURCE Sanofi Pasteur
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