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news.Sanofi Pasteur has initiated its Phase II clinical study of a vaccine for primary prevention of clostridium difficile infection (CDI).
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The Phase II trial expects to recruit approximately 650 participants at some 30 health-care centers across the US
Sanofi Pasteur’s, the vaccines division of Sanofi-aventis Group, Phase II trial is focused on evaluating prevention of the first episode of CDI in at-risk individuals, which includes adults with imminent hospitalisation or current or impending residence in a long-term care or rehabilitation facility.
The Sanofi Pasteur trial is investigating the safety and immunogenicity of different formulations of a clostridium difficile toxoid vaccine administered in adults aged 40 to 75 years who are at risk of C. difficile infection.
Sanofi Pasteur R&D senior vice president Michel DeWilde said that Sanofi Pasteur has chosen a well established approach for this particular vaccine Toxoids have been used as the basis of a number of highly successful vaccines.
"This candidate vaccine has completed phase I clinical trials in more than 200 participants to evaluate its safety and immunogenicity," DeWilde said.
The US Food and Drug Administration recently granted fast-track designation to Sanofi Pasteur’s investigational clostridium difficile vaccine candidate.