CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 550 enrolled
Drug / intervention
VAXCHORA (Cholera Vaccine, Live, Oral) +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03220737
NCT03220737Phase 4Completed
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A Phase 4 Study to Assess the Safety and Immunogenicity of VAXCHORA (Cholera Vaccine, Live, Oral) in Children 2 to <18 Years of Age

Bavarian Nordic·interventional·Posted Jul 18, 2017·Updated Jun 28, 2023

In Brief

A Phase 4 clinical trial evaluating VAXCHORA (Cholera Vaccine, Live, Oral) and Placebo for Cholera (Disorder). Completed, enrolled 550 participants across 10 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCholera (Disorder)
CountriesUnited States
CollaboratorsEmergent BioSolutions

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedJul 18, 2017
Enrollment StartJul 21, 2017
Primary CompletionSep 10, 2019
Study CompletionMar 6, 2020
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 9.0 years ago

Interventions

VAXCHORA (Cholera Vaccine, Live, Oral)biological

VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.

Placeboother

Placebo control for this study is normal (0.9%) saline.