Last updated on August 2013

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


Brief description of study

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

Detailed Study Description

The aim of this study is to evaluate the efficacy of the candidate Clostridium difficile (C. difficile) vaccine to prevent primary symptomatic C. difficile infection (CDI) in subjects a risk for CDI where there is a substantial unmet medical need.

Primary objective:

To assess the efficacy of the C. difficile vaccine in preventing the onset of symptomatic primary CDI confirmed by polymerase chain reaction (PCR) in adult subjects aged ≥ 50 years who are at risk for CDI and have received at least 1 injection.

Secondary Objectives:

Efficacy:

  • To assess prevention of symptomatic PCR-confirmed primary CDI cases after 3 injections administered at 0, 7, and 30 days
  • To assess prevention of symptomatic PCR-confirmed primary CDI cases after completion of at least 2 injections.

Immunogenicity:

  • To describe the immunogenicity to toxin A and toxin B in the subset of subjects at specific time points.

Safety:

  • To describe the safety profile of all subjects who receive at least 1 injection.

Clinical Study Identifier: TX81089

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Tyler Prater

Community Clinical Research Center
Anderson, IN USA
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