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

Clostridium Difficile Infection Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00772954
• Other study ID #: H-030-010
• Status: Terminated
• Phase: Phase 1
• First received: October 10, 2008
• Last updated: April 19, 2012
• Start date: March 2006
• Est. completion date: June 2006

Study information

• Verified date: April 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Clostridium Difficile Diarrhea
• Clostridium Difficile Infection

Intervention

Biological:
• Vaccine diluent buffer
0.5 mL, Intramuscular at Day 0, Day 28 and Day 56, respectively.
• Clostridium difficile toxoid vaccine (50 µg)
0.5 mL, Intramuscular at Day 0, Day 28 and Day 56, respectively.
• Clostridium difficile toxoid vaccine (100 µg)
0.5 mL, Intramuscular on Day 0, Day 28 and Day 56, respectively.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No