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.
This is a randomized, placebo-controlled, double-blind, single-crossover study with three age cohorts and two treatment groups within each cohort.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
550
VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
Placebo control for this study is normal (0.9%) saline.
Emory University
Atlanta, Georgia, United States
Johnson County Clin-Trials, Inc.
Lenexa, Kansas, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Cohort 1 (12-17 Yrs) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae
The proportion of subjects achieving seroconversion of serum vibriocidal antibody (SVA) against the classical Inaba biotype of V. cholerae at Day 11 following one dose of VAXCHORA, defined as a 4-fold or greater rise over baseline Day 1 SVA titer
Time frame: Day 11
Cohort 2 (6 to <12 Years) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae
The proportion of subjects achieving seroconversion of serum vibriocidal antibody (SVA) against the classical Inaba biotype of V. cholerae at Day 11 following one dose of VAXCHORA, defined as a 4-fold or greater rise over baseline Day 1 SVA titer.
Time frame: Day 11
Cohort 3 (2 to <6 Years) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae
The proportion of subjects achieving seroconversion of serum vibriocidal antibody (SVA) against the classical Inaba biotype of V. cholerae at Day 11 following one dose of VAXCHORA, defined as a 4-fold or greater rise over baseline Day 1 SVA titer.
Time frame: Day 11
Cohort 1 (12-17 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years
The seroconversion rate is defined as the percentage of subjects with a 4-fold or greater rise over baseline Day 1 Serum Vibriocidal Antibody (SVA) titer against the classical Inaba biotype of V. cholerae at Day 11 following one dose of Vaxchora vaccine. The hypothesis was that the pediatric seroconversion rate would be non-inferior to the seroconversion rate at Day 11 in adults between the ages of 18 and 45 years.
Time frame: Day 11
Cohort 2 (6-11 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years
The seroconversion rate is defined as the percentage of subjects with a 4-fold or greater rise over baseline Day 1 Serum Vibriocidal Antibody (SVA) titer against the classical Inaba biotype of V. cholerae at Day 11 following one dose of Vaxchora vaccine. The hypothesis was that the pediatric seroconversion rate would be non-inferior to the seroconversion rate at Day 11 in adults between the ages of 18 and 45 years.
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University of Kentucky
Lexington, Kentucky, United States
Boston Medical Center
Boston, Massachusetts, United States
The Center for Pharmaceutical Research
Kansas City, Missouri, United States
Rochester Clinical Research, Inc.
Rochester, New York, United States
Aventiv Research Inc.
Columbus, Ohio, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, United States
Time frame: Day 11
Cohort 3 (2-5 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years
The seroconversion rate is defined as the percentage of subjects with a 4-fold or greater rise over baseline Day 1 Serum Vibriocidal Antibody (SVA) titer against the classical Inaba biotype of V. cholerae at Day 11 following one dose of Vaxchora vaccine. The hypothesis was that the pediatric seroconversion rate would be non-inferior to the seroconversion rate at Day 11 in adults between the ages of18 and 45 years.
Time frame: Day 11
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 29
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 29 for all subjects
Time frame: Day 29
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 91
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 91 for all subjects
Time frame: Day 91
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 181
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 181 for all subjects
Time frame: Day 181
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 365
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 365 for all subjects
Time frame: Day 365
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 547
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 547 for all subjects
Time frame: Day 547
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 730
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 730 for all subjects
Time frame: Day 730
Cohort 2 (6 to <12 Years) - Seroconversion of SVA - Day 29
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 29 for all subjects
Time frame: Day 29
Cohort 3 (2 to <6 Years) - Seroconversion of SVA - Day 29
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 29 for all subjects
Time frame: Day 29