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NCT02094586 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Lot to Lot Consistency Study of Live Oral Cholera Vaccine, PXVX0200 in Healthy Adults
A Phase 3 study, sponsored by Bavarian Nordic.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,146
- Enrollment target
NCT02094586: Completed Phase 3 study, sponsored by Bavarian Nordic.
NCT02094586 is a Phase 3 study that has completed, run by Bavarian Nordic. The registered enrollment target is 3,146 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (308% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02094586, a Phase 3 study, has completed, sponsored by Bavarian Nordic.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,146 participants
- Enrollment target
Study Summary
The primary goal of this Phase III study is to compare 3 lots for consistency of manufacture.
Primary Outcome
The primary analysis consisted of three between-lot equivalence tests of serum vibriocidal antibody titer measured at Day 11. The GMT of each lot - µA, µB, and µC - was calculated by first log-transforming (base 10) the serum vibriocidal antibody titers, computing the means of the transformed data by lot, and then exponentiating the log-scale means to return to the original, untransformed scale. The resulting GMTs were combined to form three geometric mean ratios: µA/µB, µA/µC, and µB/µC.The rat
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL PXVX0200 Lot A
- BIOLOGICAL PXVX0200 Lot B
- BIOLOGICAL PXVX0200 Lot C
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,146 participants |
| Start Date | 2014-05 |
| Est. Completion | 2015-06 |
| Phase | Phase 3 |
What the finished NCT02094586 record still lists
NCT02094586 is an interventional study that assigns participants to a tested intervention. Its 3,146 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (308% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02094586 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02094586 about?
NCT02094586 is a clinical study titled "A Phase 3 Lot to Lot Consistency Study of Live Oral Cholera Vaccine, PXVX0200 in Healthy Adults". The primary goal of this Phase III study is to compare 3 lots for consistency of manufacture.
What is the current status of trial NCT02094586?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,146 participants. The study started on 2014-05. Estimated completion is 2015-06.
What interventions are being tested in trial NCT02094586?
The interventions under investigation include: Placebo (BIOLOGICAL), PXVX0200 Lot A (BIOLOGICAL), PXVX0200 Lot B (BIOLOGICAL), PXVX0200 Lot C (BIOLOGICAL).
Who is sponsoring clinical trial NCT02094586?
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 NCT02094586's enrollment target sits among peer trials
3,146 75th of 2000 higher than 1,926 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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