Safety, Tolerability, and Immunogenicity of a Clostridium Difficile Toxoid Vaccine in Healthy Elderly Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Clostridium Infections

In brief

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 healthy elderly subjects aged \> or = 65 years. This is the companion study to H-030-008, in which healthy younger adults have already been dosed.

Key facts

Study ID

NCT00214461

Run by

Sanofi

People needed

48

Starts

2005-11-01

Expected to finish

2006-02-01

Last updated by the study team

2012-04-11

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Orlando Clinical Research Center — Orlando, Florida, United States
• University of Kentucky — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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