Efficacy, Immunogenicity, and Safety Study of Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection

Trial Profile

Efficacy, Immunogenicity, and Safety Study of Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection

Discontinued
Phase of Trial: Phase III

Latest Information Update: 08 Dec 2017

At a glance

  • Drugs Clostridium difficile vaccine (Primary)
  • Indications Clostridium infections
  • Focus Registrational; Therapeutic Use
  • Acronyms Cdiffense
  • Sponsors sanofi pasteur
  • Most Recent Events

    • 01 Dec 2017 Status changed from suspended to discontinued, according to a Sanofi media release,
    • 01 Dec 2017 According to a Sanofi media release, the Company has decided to discontinue clinical development of its Clostridium difficile vaccine, to focus on six key vaccine projects currently in development. The decision was based on the outcome of a planned interim analysis of the Independent Data Monitoring Committee (IDMC) for the Cdiffense clinical trial program which concluded that the probability that the study will meet its primary objective is low.
    • 01 Dec 2017 This Trial has been suspended in Germany according to European Clinical Trials Database record.
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