NCT03220737

VAXCHORA Pediatric Study to Assess Safety and Immunogenicity

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 550 (actual)
• Sponsor: Bavarian Nordic · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a randomized, placebo-controlled, double-blind, single-crossover study with three age cohorts and two treatment groups within each cohort.

Conditions

• Cholera (Disorder)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-07-21
• Primary completion: 2019-09-10
• Completion: 2020-03-06
• First posted: 2017-07-18
• Last updated: 2023-06-28
• Results posted: 2020-11-19

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study