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NCT02100631 · ClinicalTrials.gov registry record · Phase 3
A Study of Live Oral Cholera Vaccine, PXVX200 in Healthy Older Adults
A Phase 3 study, sponsored by Bavarian Nordic.
- Completed
- Registry status
- Phase 3
- Development phase
- 398
- Enrollment target
NCT02100631: Completed Phase 3 study, sponsored by Bavarian Nordic.
NCT02100631 is a Phase 3 study that has completed, run by Bavarian Nordic. The registered enrollment target is 398 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02100631, a Phase 3 study, has completed, sponsored by Bavarian Nordic.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 398 participants
- Enrollment target
Study Summary
Demonstrate that the vaccine offers protection based on antibody levels in older adults and is similar to antibody levels in adults aged 18-45 following vaccination with PXVX0200.
Primary Outcome
The seroconversion rate is defined as the percentage of subjects with a 4-fold or greater rise over baseline Day 1 Serum Vibriocidal Antibody (SVA) titer against the classical Inaba biotype of V. cholerae at Day 11 following one dose of Vaxchora vaccine. The hypothesis was that the seroconversion rate would be non-inferior to the seroconversion rate at Day 11 in adults between the ages of 18 and 45 years.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL PXVX0200
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 398 participants |
| Start Date | 2014-05 |
| Est. Completion | 2015-06 |
| Phase | Phase 3 |
What the finished NCT02100631 record still lists
NCT02100631 is an interventional study that assigns participants to a tested intervention. The registered 398 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 (48% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02100631 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02100631 about?
NCT02100631 is a clinical study titled "A Study of Live Oral Cholera Vaccine, PXVX200 in Healthy Older Adults". Demonstrate that the vaccine offers protection based on antibody levels in older adults and is similar to antibody levels in adults aged 18-45 following vaccination with PXVX0200.
What is the current status of trial NCT02100631?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 398 participants. The study started on 2014-05. Estimated completion is 2015-06.
What interventions are being tested in trial NCT02100631?
The interventions under investigation include: Placebo (BIOLOGICAL), PXVX0200 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02100631?
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 NCT02100631's enrollment target sits among peer trials
398 963rd of 2000 higher than 1,037 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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