clinical trial · NCT03220737
VAXCHORA Pediatric Study to Assess Safety and Immunogenicity
Bavarian Nordic·phase4·completed·n = 550
Cholera (Disorder)VAXCHORA (Cholera Vaccine, Live, Oral)Placebo
brief 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.
started
Jul 21, 2017
primary completion
Sep 10, 2019
completion
Mar 6, 2020
last updated
Jun 28, 2023
detailed description
This is a randomized, placebo-controlled, double-blind, single-crossover study with three age cohorts and two treatment groups within each cohort.
official title
A Phase 4 Study to Assess the Safety and Immunogenicity of VAXCHORA (Cholera Vaccine, Live, Oral) in Children 2 to <18 Years of Age
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol