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Study of a Candidate Clostridium Difficile Toxoid Vaccine in Healthy Adult Subjects Aged 40 to 75 Years in Japan

Clostridium Difficile Infection Clinical Trial

Official title:
Safety and Immunogenicity of a Clostridium Difficile Toxoid Vaccine Administered to Healthy Adult Subjects Aged 40 to 75 Years in Japan

Clinical Trial Summary

The aim of the study is to evaluate a candidate C. difficile Toxoid Vaccine in the Japanese population.

Primary objectives:

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

- To describe the immunogenicity to toxin A and toxin B in all subjects from serum samples obtained on Days 0, 14, 30, and 60.

Clinical Trial Description

Participants will be randomly assigned to receive the vaccine or placebo on the selected schedule. Safety parameters, solicited injection site and systemic reactions will be collected for 6 days after each injection; unsolicited adverse events including serious adverse events will be collected up to Day 60 post-vaccination. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01896830
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 1/Phase 2
Start date July 2013
Completion date June 2014
View Details
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