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

PHASE1CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

November 30, 2005

Primary Completion Date

February 28, 2006

Study Completion Date

February 28, 2006

Conditions
Clostridium Infections
Interventions
BIOLOGICAL

Vaccine diluent buffer (Placebo)

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

BIOLOGICAL

C. difficile toxoid vaccine (2 µg)

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

BIOLOGICAL

C. difficile toxoid vaccine (10 µg)

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

BIOLOGICAL

C. difficile toxoid vaccine (50 µg)

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

Trial Locations (2)

32809

Orlando Clinical Research Center, Orlando

40536

University of Kentucky, Lexington

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY