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

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00772954

Purpose

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

Condition	Intervention	Phase
Colstridium Difficile Associated Disease	Biological: Modified C. difficile vaccine	Phase I

Drug Information available for: Alum, potassium Aluminum sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
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)

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Safety of vaccine [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Immunogenicity [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	36
Study Start Date:	March 2006
Study Completion Date:	June 2006
Estimated Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Intervention Details:

50 mcg given at Weeks 0, 4 and 8.

Detailed Description:

This was a Phase I, randomized, placebo-controlled, double-blinded, dose ranging study designed to assess the safety, tolerability, and immunogenicity of modified 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 modified C. difficile vaccine (50 or 100 mcg) or placebo (vehicle control containing alum).

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772954

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Principal Investigator:

Dennis N Morrison, D.O.

Bio-Kinetic Clinical Applications, Inc.

More Information

Responsible Party:	sanofi pasteur ( Vicki Tyler, Clinical Program Manager )
Study ID Numbers:	H-030-010
Study First Received:	October 10, 2008
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00772954
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Aluminum sulfate
Healthy

ClinicalTrials.gov processed this record on January 14, 2009