NCT01896830

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Clostridium Difficile Infection

Interventions

Type	Name	Description
BIOLOGICAL	Clostridium difficile Toxoid Vaccine	0.5 mL, intramuscular
BIOLOGICAL	0.9% normal saline	0.5 mL, intramuscular

Timeline

• Start date: 2013-07-01
• Primary completion: 2013-10-01
• Completion: 2014-06-01
• First posted: 2013-07-11
• Last updated: 2018-07-18

Locations

1 site across 1 country: Japan