Diarrhea Clinical Trial
Official title:
Safety and Immunogenicity of Different Formulations of a Clostridium Difficile Toxoid Vaccine Administered at Three Different Schedules in Adults Aged 40 to 75 Years at Risk of C. Difficile Infection
This study will further evaluate the ACAM-CDIFF™ vaccine in a population of middle-aged to
elderly individuals at risk of exposure to Clostridium difficile because of impending
hospitalization or residence in a care facility.
Primary Objectives:
- To describe the safety profile of subjects in each of the study groups.
- To describe the immune responses elicited by toxoid A and toxoid B of subjects in each
of the study groups.
Observational Objective:
- To describe the occurrence of first-time Clostridium difficile infection (CDI) episodes.
Participants will receive 3 doses of either one of 4 different formulations of ACAM-CDIFF™
vaccine or placebo, on one of 3 different schedules. The trial will have 2 stages. Stage I
will test 4 different formulations of ACAM-CDIFF™ vaccine. Stage II will explore different
vaccination schedules using one of these formulations.
Participants will be followed up for safety and immunogenicity; stool samples will also be
provided in case of diarrhea.
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