Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study, Safety, Tolerability and Immunogenicity

Phase 1

Terminated

• Conditions: Clostridium Difficile Diarrhea; Clostridium Difficile Infection
• Interventions: Biological: Vaccine diluent buffer; Biological: Clostridium difficile toxoid vaccine (50 μg); Biological: Clostridium difficile toxoid vaccine (100 μg)

• Registration Number: NCT00772954
• Lead Sponsor: Sanofi

Brief Summary

This Phase I, randomized, placebo-controlled, double-blinded, dose ranging study to assess the safety, tolerability, and immunogenicity of 2 dose levels of C. difficile vaccine. Population: healthy male and female adults, 18 to 55 years old.

Detailed Description

This was a Phase I, randomized, placebo-controlled, double-blinded, dose ranging study designed to assess the safety, tolerability, and immunogenicity of C. difficile vaccine. The study was conducted in healthy male and female adults, 18 to 55 years old. Subjects was randomly assigned on Day 0 to receive one of two doses of C. difficile vaccine (50 or 100 mcg) or placebo (vehicle control containing alum).

Study Timeline

• Study Start: 2006-03
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Study First Submitted: 2008-10-10
• Study First Submitted QC: 2008-10-10
• Study First Posted: 2008-10-15
• Results First Submitted: 2012-03-13
• Status Verified: 2012-04
• Results First Submitted QC: 2012-04-19
• Last Update Submitted: 2012-04-19
• Results First Posted: 2012-05-21
• Last Update Posted: 2012-05-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Adult males or females, 18 - 55 years in good general health

Exclusion Criteria

• Evidence of current C. difficile infection, as determined by a positive stool C. difficile cytotoxin assay at screening
• Evidence of any previous antibiotic-associated diarrhea caused by any etiology including C. difficile that required medical intervention or medication
• Active or inactive irritable bowel disease, chronic abdominal pain, chronic diarrhea of any etiology, or inflammatory bowel disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo vaccine group	Vaccine diluent buffer	Participants scheduled to receive a dose of placebo vaccine on Day 0, Day 28, and Day 56, respectively.
Clostridium Difficile Vaccine Group 1	Clostridium difficile toxoid vaccine (50 μg)	Participants scheduled to receive a dose of 50 μg Clostridium Difficile vaccine on Day 0, Day 28, and Day 56, respectively.
Clostridium Difficile Vaccine Group 2	Clostridium difficile toxoid vaccine (100 μg)	Participants scheduled to receive a dose of 100 μg Clostridium Difficile vaccine on Day 0, Day 28, and Day 56, respectively.

Primary Outcome Measures

Name	Time	Method
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine.	Day 0 up to 70 days post first vaccination