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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: Clinical Trial Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
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, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1106% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Symptomatic PCR-confirmed CDI cases were defined as the number of participants with combination of clinical and laboratory findings. Clinical components were: \>= 3 loose stools in \<= 24 hours, loose stools (defined as type 6 \[fluffy pieces with ragged edges, mushy\] or type 7 \[watery, no solid pieces\] according to the Bristol Stool Chart) lasting \>= 24 hours. Laboratory findings were: stool sample positive for C. difficile Toxin B by PCR at central laboratory or diagnosis of pseudomembrano
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 |
Why NCT01887912 stopped before completion
NCT01887912 is an interventional study that assigns participants to a tested intervention. Its 9,302 participants enrollment target places it among the larger protocols in the corpus, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1106% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo: 0.9% normal saline is the first listed.
NCT01887912 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01887912's enrollment target sits among peer trials
9,302 31st of 2000 higher than 1,970 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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