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NCT01585181 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity of the Live Oral Cholera Vaccine Candidate PXVX0200
A Phase 1 study, sponsored by Bavarian Nordic.
- Completed
- Registry status
- Phase 1
- Development phase
- 66
- Enrollment target
NCT01585181: Completed Phase 1 study, sponsored by Bavarian Nordic.
NCT01585181 is a Phase 1 study that has completed, run by Bavarian Nordic. The registered enrollment target is 66 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01585181, a Phase 1 study, has completed, sponsored by Bavarian Nordic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 66 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the safety and immunogenicity of a single dose of the PXVX0200 live cholera vaccine versus placebo in volunteers (Vaccinees) and whether PXVX0200, which is a live attenuated bacteria, can be transmitted to other adults living in the same household.
Primary Outcome
Safety defined as frequency and severity of vaccine-related reactogenicity events and reported AEs
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL PXVX0200
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2012-04 |
| Est. Completion | 2013-01 |
| Phase | Phase 1 |
What the finished NCT01585181 record still lists
NCT01585181 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01585181 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01585181 about?
NCT01585181 is a clinical study titled "Safety and Immunogenicity of the Live Oral Cholera Vaccine Candidate PXVX0200". The purpose of this study is to compare the safety and immunogenicity of a single dose of the PXVX0200 live cholera vaccine versus placebo in volunteers (Vaccinees) and whether PXVX0200, which is a live attenuated bacteria, can be transmitted to other adults living in the same household.
What is the current status of trial NCT01585181?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2012-04. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01585181?
The interventions under investigation include: Placebo (BIOLOGICAL), PXVX0200 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01585181?
This trial is sponsored by Bavarian Nordic, which has 41 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01585181's enrollment target sits among peer trials
66 786th of 2000 higher than 1,203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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