FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Sanofi Shelves C. diff Vaccine in Phase III Trial

Dec. 7, 2017

Sanofi discontinued clinical development of its Clostridium difficile vaccine, following a Phase III interim analysis that showed a low probability of success. Investigators are notifying study volunteers of the decision to stop the program.

The company’s Cdiffense clinical trial program was designed to test a toxoid vaccine in a subpopulation at risk for infection. C. difficile infections are more common in professional healthcare settings such as hospitals and nursing homes.

Sanofi Pasteur, the company’s vaccine unit, said it would refocus efforts on six vaccine projects currently under development, and plans to share data from all vaccinated volunteers with the scientific community.

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