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NCT01895855 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Challenge Study of Live Oral Cholera Vaccine Candidate,PXVX0200, to Prevent Cholera
A Phase 3 study of Cholera, sponsored by Bavarian Nordic.
- Completed
- Registry status
- Phase 3
- Development phase
- 197
- Enrollment target
- 3
- Study locations
NCT01895855: Completed Phase 3 study of Cholera, sponsored by Bavarian Nordic.
NCT01895855 is a Phase 3 study of Cholera that has completed, run by Bavarian Nordic. The registered enrollment target is 197 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01895855, a Phase 3 study of Cholera, has completed, sponsored by Bavarian Nordic.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 197 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of the study is to determine if PXVX0200 is safe and effective in preventing cholera infection
Primary Outcome
Determine whether a single dose of PXVX0200 provides significantly greater protection than placebo against a challenge with virulent V. cholerae O1 El Tor Inaba at 10 days after vaccination. The primary endpoint was the occurrence of moderate or severe (\>/= 3 liters) diarrhea.
Conditions Studied
Interventions
- BIOLOGICAL placebo
- BIOLOGICAL PXVX0200
Study Locations (3)
Maryland
- University of Maryland Baltimore - Baltimore
Ohio
- Cincinnati Children'S Hospital Medical Center - Cincinnati
Vermont
- University of Vermont - Burlington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 197 participants |
| Start Date | 2013-09 |
| Est. Completion | 2014-11 |
| Phase | Phase 3 |
What the finished NCT01895855 record still lists
NCT01895855 is an interventional study that assigns participants to a tested intervention. The registered 197 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower).
The record links to 1 condition, with Cholera appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT01895855 reports a single indexed study location in Maryland, Ohio, Vermont.
Frequently Asked Questions
What is clinical trial NCT01895855 about?
NCT01895855 is a clinical study titled "Safety and Efficacy Challenge Study of Live Oral Cholera Vaccine Candidate,PXVX0200, to Prevent Cholera". The purpose of the study is to determine if PXVX0200 is safe and effective in preventing cholera infection
What is the current status of trial NCT01895855?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 197 participants. The study started on 2013-09. Estimated completion is 2014-11.
What conditions does trial NCT01895855 study?
This clinical trial studies the following conditions: Cholera.
What interventions are being tested in trial NCT01895855?
The interventions under investigation include: placebo (BIOLOGICAL), PXVX0200 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01895855?
This trial is sponsored by Bavarian Nordic, which has 41 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01895855 being conducted?
This trial has 3 study locations across Maryland, Ohio, Vermont. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01895855's enrollment target sits among peer trials
197 1390th of 2000 higher than 611 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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