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

PHASE1CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

July 31, 2005

Primary Completion Date

January 31, 2006

Study Completion Date

March 31, 2006

Conditions
Clostridium Infections
Interventions
BIOLOGICAL

Placebo (vaccine diluent)

0.5 mL, intramuscular (IM) on Days 0, 28, and 56, respectively.

BIOLOGICAL

Clostridium difficile vaccine

0.5 mL, intramuscular on Days 0, 28, and 56, respectively.

BIOLOGICAL

Clostridium difficile vaccine

0.5 mL, intramuscular on Days 0, 28, and 56, respectively.

BIOLOGICAL

Clostridium difficile vaccine

0.5 mL, intramuscular on Days 0, 28, and 56, respectively.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY