Status:
COMPLETED
Safety, Tolerability, and Immunogenicity of a Clostridium Difficile Toxoid Vaccine in Healthy Elderly Volunteers
Lead Sponsor:
Sanofi
Conditions:
Clostridium Infections
Eligibility:
All Genders
65+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safety and tolerability of a modified C. difficile vaccine at 3 dose levels compared with a placebo control administered via intramuscular injection in he...
Detailed Description
Clostridium difficile is the leading infectious cause of nosocomial diarrhea in developed countries. Hospital outbreaks of Clostridium difficile-associated diarrhea (CDAD) are associated with substant...
Eligibility Criteria
Inclusion
- Adult males or females, \> or = 65 years
- In good general health
- Clinical lab tests within normal range
- Females must be post-menopausal
- Able and willing to participate for duration of study and must not participate in any other experimental study for at least 60 days after receiving the last dose of study vaccine
Exclusion
- Evidence of C. difficile infection
- Evidence of any previous antibiotic-associated diarrhea
- Active or inactive inflammatory bowel disease, irritable colon syndrome, chronic abdominal pain or other chronic diarrhea
- History of malignancy within 5 years
- History of anaphylaxis, asthma or severe vaccine or severe allergic drug reaction
- Known or suspected history of immunodeficiency
- Active or inactive immune-mediated or inflammatory disease
- History of drug or alcohol abuse disorders;
- Serology positive for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
- Receipt of antibiotic therapy or an investigational drug within prior 30 days
- Blood or organ donation within prior 30 days.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00214461
Start Date
November 1 2005
End Date
February 1 2006
Last Update
April 11 2012
Active Locations (2)
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1
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
2
University of Kentucky
Lexington, Kentucky, United States, 40536