Phase 4 N=3,238 Randomized Quadruple-blind Prevention

VAXCHORA Pediatric Study to Assess Safety and Immunogenicity

Cholera (Disorder)

Bottom Line

View on ClinicalTrials.gov: NCT03220737 ↗

Enrolled (actual)

3,238

Serious AEs

0.9%

Results posted

Nov 2020

Primary outcome: Primary: Cohort 1 (12-17 Yrs) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae — 99.4; 0 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: VAXCHORA (Cholera Vaccine, Live, Oral) (Biological); Placebo (Other)
Age: Pediatric · 2+ yrs
Sex: All
Sponsor: Bavarian Nordic
Primary completion: Sep 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Cohort 1 (12-17 Yrs) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae	99.4; 0	—
PRIMARY Cohort 2 (6 to <12 Years) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae	97.8; 4.2	—
PRIMARY Cohort 3 (2 to <6 Years) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae	98.1; 0	—
PRIMARY Cohort 1 (12-17 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years	99.4; 93.5	—
PRIMARY Cohort 2 (6-11 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years	97.8; 93.5	—
PRIMARY Cohort 3 (2-5 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years	98.1; 93.5	—
SECONDARY Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 29	100; 0	<0.0001 sig
SECONDARY Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 91	85.6; 0	<0.0001 sig
SECONDARY Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 181	73.5; 0	<0.0001 sig
SECONDARY Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 365	68.6	—
SECONDARY Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 547	73.1	—
SECONDARY Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 730	64.5	—
SECONDARY Cohort 2 (6 to <12 Years) - Seroconversion of SVA - Day 29	94.9; 4.3	<0.0001 sig
SECONDARY Cohort 3 (2 to <6 Years) - Seroconversion of SVA - Day 29	93.9; 0	<0.0001 sig

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.

Eligibility Criteria

Inclusion Criteria

Male or Female
Between 2 and 2 weeks of abnormal stool pattern, defined as 2 stools per day in the past 6 months
Regular use of laxatives in the past 6 months
History of enterotoxigenic E. coli infection
Travel to cholera-endemic area in the previous 5 years
Nursing/Breastfeeding
Received or plans to receive the following from 14 days prior to the study vaccination through 11 days after vaccination: Any other licensed vaccines, antibiotics, or chloroquine
Received or plans to receive any other investigational agent throughout the main study (Day 181)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03220737). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.