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