Status:
TERMINATED
Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study, Safety, Tolerability and Immunogenicity
Lead Sponsor:
Sanofi
Conditions:
Clostridium Difficile Infection
Clostridium Difficile Diarrhea
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 ma...
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 ...
Eligibility Criteria
Inclusion
- Adult males or females, 18 - 55 years in good general health
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00772954
Start Date
March 1 2006
End Date
June 1 2006
Last Update
May 21 2012
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.