drugset / Trial / NCT00772343

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

NCT00772343 ↗

Phase 2 Completed 116 enrolled Sanofi Pasteur, a Sanofi Company
RandomizedFactorialTriple-blindTreatment

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.

Timeline

Start
2009-02
Primary completion
2011-07
Completion
2012-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Clostridium difficile toxoid vaccine Vaccine 0.5 ml Intramuscular