Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-24 @ 6:41 PM
NCT ID:
NCT01230957
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT01230957
Study Brief:
Protocol Section:
NCT01230957