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

PHASE1TerminatedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

March 31, 2006

Primary Completion Date

June 30, 2006

Study Completion Date

June 30, 2006

Conditions
Clostridium Difficile InfectionClostridium Difficile Diarrhea
Interventions
BIOLOGICAL

Vaccine diluent buffer

0.5 mL, Intramuscular at Day 0, Day 28 and Day 56, respectively.

BIOLOGICAL

Clostridium difficile toxoid vaccine (50 μg)

0.5 mL, Intramuscular at Day 0, Day 28 and Day 56, respectively.

BIOLOGICAL

Clostridium difficile toxoid vaccine (100 μg)

0.5 mL, Intramuscular on Day 0, Day 28 and Day 56, respectively.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY

NCT00772954 - Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study, Safety, Tolerability and Immunogenicity | Biotech Hunter | Biotech Hunter