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NCT03220737 · ClinicalTrials.gov registry record · Phase 4
VAXCHORA Pediatric Study to Assess Safety and Immunogenicity
A Phase 4 study, sponsored by Bavarian Nordic.
- Completed
- Registry status
- Phase 4
- Development phase
- 550
- Enrollment target
NCT03220737: Completed Phase 4 study, sponsored by Bavarian Nordic.
NCT03220737 is a Phase 4 study that has completed, run by Bavarian Nordic. The registered enrollment target is 550 participants, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03220737, a Phase 4 study, has completed, sponsored by Bavarian Nordic.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 550 participants
- Enrollment target
Study Summary
VAXCHORA (Cholera Vaccine, Live, Oral) is a vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1. VAXCHORA is approved for use in adults 18 through 64 years of age travelling to cholera-affected areas. The primary goals of this Phase 4 study are to evaluate the safety and immunogenicity of a single dose of VAXCHORA (1 x 10e9 cfu/dose) in children ages 2 years to \<18 years of age in developed countries.
Primary Outcome
The proportion of subjects achieving seroconversion of serum vibriocidal antibody (SVA) against the classical Inaba biotype of V. cholerae at Day 11 following one dose of VAXCHORA, defined as a 4-fold or greater rise over baseline Day 1 SVA titer
Interventions
- OTHER Placebo
- BIOLOGICAL VAXCHORA (Cholera Vaccine, Live, Oral)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 550 participants |
| Start Date | 2017-07-21 |
| Est. Completion | 2020-03-06 |
| Phase | Phase 4 |
What the finished NCT03220737 record still lists
NCT03220737 is an interventional study that assigns participants to a tested intervention. The registered 550 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03220737 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03220737 about?
NCT03220737 is a clinical study titled "VAXCHORA Pediatric Study to Assess Safety and Immunogenicity". VAXCHORA (Cholera Vaccine, Live, Oral) is a vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1. VAXCHORA is approved for use in adults 18 through 64 years of age travelling to cholera-affected areas. The primary goals of this Phase 4 study are to evaluat...
What is the current status of trial NCT03220737?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 550 participants. The study started on 2017-07-21. Estimated completion is 2020-03-06.
What interventions are being tested in trial NCT03220737?
The interventions under investigation include: Placebo (OTHER), VAXCHORA (Cholera Vaccine, Live, Oral) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03220737?
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 NCT03220737's enrollment target sits among peer trials
550 152nd of 2000 higher than 1,848 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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