ARTICLE | Clinical News

Sanofi discontinues C. difficile vaccine

December 8, 2017 7:03 PM UTC

Sanofi (Euronext:SAN; NYSE:SNY) discontinued development of its late-stage Clostridium difficile vaccine (ACAM-CDIFF) after an interim analysis by the trial's IDMC concluded that the candidate is unlikely to meet the primary endpoint of the Phase III Cdiffense trial. The trial's primary endpoint is the number of symptomatic PCR-confirmed primary C. difficile infection (CDI) cases after at least 1 injection.

The single-blind, placebo-controlled, international trial evaluated single injections of the vaccine given on days 0, 7 and 30 in about 16,500 adult volunteers ages 50 and older who are planning an upcoming hospitalization or have had at least 2 hospital stays and have received systemic antibiotics in the past year. Secondary endpoints include the number of PCR-confirmed primary CDI cases after 2 and 3 injections, severe PCR-confirmed primary CDI cases, maximum number of loose stools per day, CDI episode/illness duration, immunogenicity and injection-site and systemic reactions...

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