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NCT01230957 · ClinicalTrials.gov registry record · Phase 2
Study of Different Formulations of a Clostridium Difficile Toxoid Vaccine Given at Three Different Schedules in Adults
A Phase 2 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 650
- Enrollment target
NCT01230957 is a Phase 2 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 650 participants.
The verdict
NCT01230957, a Phase 2 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 650 participants
- Enrollment target
Study 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.
Interventions
- BIOLOGICAL Clostridium difficile toxoids A and B (Low-dose with adjuvant)
- BIOLOGICAL Clostridium difficile toxoids A and B (Low-dose without adjuvant)
- BIOLOGICAL Clostridium difficile toxoids A and B (high-dose with adjuvant)
- BIOLOGICAL Clostridium difficile toxoids A and B (high-dose without adjuvant)
- BIOLOGICAL Placebo: 0.9% normal saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 650 participants |
| Start Date | 2010-10 |
| Est. Completion | 2013-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01230957
The ClinicalTrials.gov registry entry for NCT01230957 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 650 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 153 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Clostridium difficile toxoids A and B (Low-dose with adjuvant) is the first listed.
NCT01230957 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01230957 about?
NCT01230957 is a clinical study titled "Study of Different Formulations of a Clostridium Difficile Toxoid Vaccine Given at Three Different Schedules in Adults". 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...
What is the current status of trial NCT01230957?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 650 participants. The study started on 2010-10. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01230957?
The interventions under investigation include: Clostridium difficile toxoids A and B (Low-dose with adjuvant) (BIOLOGICAL), Clostridium difficile toxoids A and B (Low-dose without adjuvant) (BIOLOGICAL), Clostridium difficile toxoids A and B (high-dose with adjuvant) (BIOLOGICAL), Clostridium difficile toxoids A and B (high-dose without adjuvant) (BIOLOGICAL), Placebo: 0.9% normal saline (BIOLOGICAL).
Who is sponsoring clinical trial NCT01230957?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
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