NCT00772954

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

A Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study of the Safety, Tolerability and Immunogenicity of Two Doses of a Clostridium Difficile Toxoid Vaccine, Alum Adsorbed, in Healthy Adult Volunteers (18 - 55 Years)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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).

Conditions

• Clostridium Difficile Infection
• Clostridium Difficile Diarrhea

Interventions

Type	Name	Description
BIOLOGICAL	Vaccine diluent buffer	0.5 mL, Intramuscular at Day 0, Day 28 and Day 56, respectively.
BIOLOGICAL	Clostridium difficile toxoid vaccine (50 μg)	0.5 mL, Intramuscular at Day 0, Day 28 and Day 56, respectively.
BIOLOGICAL	Clostridium difficile toxoid vaccine (100 μg)	0.5 mL, Intramuscular on Day 0, Day 28 and Day 56, respectively.

Timeline

• Start date: 2006-03-01
• Primary completion: 2006-06-01
• Completion: 2006-06-01
• First posted: 2008-10-15
• Last updated: 2012-05-21
• Results posted: 2012-05-21