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VAXCHORA Pediatric Study to Assess Safety and Immunogenicity

NCT03220737 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 550

Last updated 2023-06-28

Study results available
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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.

Conditions

  • Cholera (Disorder)

Interventions

BIOLOGICAL

VAXCHORA (Cholera Vaccine, Live, Oral)

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

OTHER

Placebo

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

Sponsors & Collaborators

  • Emergent BioSolutions

    collaborator INDUSTRY

  • Bavarian Nordic

    lead INDUSTRY

Principal Investigators

  • Paul Andre de Lame, MD · Emergent BioSolutions

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-21
Primary Completion
2019-09-10
Completion
2020-03-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03220737 on ClinicalTrials.gov