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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 is a Phase 2 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 116 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00772343
The ClinicalTrials.gov registry entry for NCT00772343 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 116 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 3 interventions - of which 0.9% Normal Saline is the first listed.
NCT00772343 reports 0 study locations.
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.
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