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NCT01887912 · ClinicalTrials.gov registry record · Phase 3
Study of a Candidate Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection
A Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Terminated
- Registry status
- Phase 3
- Development phase
- 9,302
- Enrollment target
NCT01887912 is a Phase 3 study that was terminated before completion, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 9,302 participants.
The verdict
NCT01887912, a Phase 3 study, was terminated before completion, sponsored by Sanofi Pasteur, a Sanofi Company.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 9,302 participants
- Enrollment target
Study Summary
The aim of this study was to evaluate the efficacy of the Clostridium difficile vaccine to prevent primary symptomatic C. difficile infection (CDI) in participants at risk for CDI where there is a substantial unmet medical need. Primary objective: * To assess the efficacy of the C. difficile vaccine in preventing the onset of symptomatic primary CDI confirmed by polymerase chain reaction (PCR) in adult participants aged \>= 50 years who are at risk for CDI and have received at least 1 injection. Secondary Objectives: Efficacy: * To assess prevention of symptomatic PCR-confirmed primary CDI cases after 3 injections administered at 0, 7, and 30 days. * To assess prevention of symptomatic PCR-confirmed primary CDI cases after completion of at least 2 injections. Immunogenicity: * To describe the immunogenicity to toxin A and toxin B at specific time points in a subset of participant and in participants with CDI at Day 0 and Day 60. Safety: * To describe the safety profile of all participants who received at least 1 injection.
Interventions
- BIOLOGICAL Placebo: 0.9% normal saline
- BIOLOGICAL C. difficile Toxoid Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9,302 participants |
| Start Date | 2013-07-30 |
| Est. Completion | 2018-06-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01887912
The ClinicalTrials.gov registry entry for NCT01887912 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 9,302 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 2 interventions - of which Placebo: 0.9% normal saline is the first listed.
NCT01887912 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01887912 about?
NCT01887912 is a clinical study titled "Study of a Candidate Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection". The aim of this study was to evaluate the efficacy of the Clostridium difficile vaccine to prevent primary symptomatic C. difficile infection (CDI) in participants at risk for CDI where there is a substantial unmet medical need. Primary objective: * To assess the efficacy of the C. difficile vacci...
What is the current status of trial NCT01887912?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 9,302 participants. The study started on 2013-07-30. Estimated completion is 2018-06-12.
What interventions are being tested in trial NCT01887912?
The interventions under investigation include: Placebo: 0.9% normal saline (BIOLOGICAL), C. difficile Toxoid Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01887912?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
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