NCT00772343

Study of a Clostridium Difficile Toxoid Vaccine (ACAM-CDIFF™) in Subjects With Clostridium Difficile Infection

A Phase II Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study of A Clostridium Difficile Toxoid Vaccine (ACAM-CDIFF™) in Subjects With Clostridium Difficile Infection (CDI)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Primary objective: To compare the event rate of CDI in groups assigned to ACAM-CDIFF™ vaccine versus placebo in the 9 week period after the third dose of the study vaccine in subjects with first episode of CDI receiving antibiotics standard of care. Secondary objective: To evaluate the safety of all dose groups of ACAM-CDIFF™ vaccine versus placebo in subjects with first episode of CDI receiving antibiotics standard of care.

Detailed description

This study is designed primarily to obtain information on the preliminary efficacy, safety and immunogenicity of ACAM-CDIFF™ vaccine, as compared to placebo in subjects who are experiencing their first event of CDI and are being treated with the antibiotic standard of care. This study will be conducted in the United States and United Kingdom. Adult subjects with limited chronic disease, who are currently receiving treatment for their first episode of CDI will be enrolled in this trial. Subjects will be required to be able to take oral antibiotics.

Conditions

• Diarrhea
• Clostridium Difficile Infection

Interventions

Type	Name	Description
BIOLOGICAL	0.9% Normal Saline	0.5 mL, intramuscular on Days 0, 7, and 28
BIOLOGICAL	Clostridium difficile toxoid vaccine	0.5 mL, intramuscular on Days 0, 7, and 28
BIOLOGICAL	Clostridium difficile toxoid vaccine with adjuvant	0.5 mL, intramuscular on Days 0, 7, and 28
BIOLOGICAL	Clostridium difficile toxoid vaccine	0.5 mL, intramuscular on Days 0, 7, and 28

Timeline

• Start date: 2009-02-01
• Primary completion: 2011-07-01
• Completion: 2012-06-01
• First posted: 2008-10-15
• Last updated: 2013-09-17

Locations

31 sites across 2 countries: United States, United Kingdom