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NCT00772343 · ClinicalTrials.gov registry record · Phase 2
Study of a Clostridium Difficile Toxoid Vaccine (ACAM-CDIFF™) in Subjects With Clostridium Difficile Infection
A Phase 2 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 116
- Enrollment target
NCT00772343: Completed Phase 2 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT00772343 is a Phase 2 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 116 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00772343, a Phase 2 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 116 participants
- Enrollment target
Study 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.
Interventions
- BIOLOGICAL 0.9% Normal Saline
- BIOLOGICAL Clostridium difficile toxoid vaccine
- BIOLOGICAL Clostridium difficile toxoid vaccine with adjuvant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2009-02 |
| Est. Completion | 2012-06 |
| Phase | Phase 2 |
What the finished NCT00772343 record still lists
NCT00772343 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 3 interventions - of which 0.9% Normal Saline is the first listed.
NCT00772343 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00772343 about?
NCT00772343 is a clinical study titled "Study of a Clostridium Difficile Toxoid Vaccine (ACAM-CDIFF™) in Subjects With Clostridium Difficile Infection". 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 al...
What is the current status of trial NCT00772343?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 116 participants. The study started on 2009-02. Estimated completion is 2012-06.
What interventions are being tested in trial NCT00772343?
The interventions under investigation include: 0.9% Normal Saline (BIOLOGICAL), Clostridium difficile toxoid vaccine (BIOLOGICAL), Clostridium difficile toxoid vaccine with adjuvant (BIOLOGICAL).
Who is sponsoring clinical trial NCT00772343?
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 NCT00772343's enrollment target sits among peer trials
116 623rd of 2000 higher than 1,375 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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