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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: Completed Phase 2 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT01230957 is a Phase 2 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 650 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (389% higher). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01230957 record still lists
NCT01230957 is an interventional study that assigns participants to a tested intervention. The registered 650 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (389% higher).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01230957's enrollment target sits among peer trials
650 50th of 2000 higher than 1,951 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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