Sanofi has decided to discontinue the clinical development of its proposed Clostridium difficile vaccine after an interim analysis concluded that the probability of the Phase 3 study meeting its primary objective was low.
The interim analysis was conducted by the Independent Data Monitoring Committee (IDMC).
The trial ‘Cdiffense’ was testing the efficacy and safety of a candidate toxoid vaccine in a subpopulation at risk of C. difficile infection. Sanofi is informing all investigators, regulatory authorities, trial ethics committees and study volunteers of their decision to stop the program.
Data that has been collected from the trial so far will be analyzed and shared with the scientific community in due time, according to a statement from the company. The statement continued on to say that the Company will focus its efforts on six separate vaccine projects currently in development.
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