Cholera Vaccine for Kids

Study 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

Age range: Children 2-12 years of age.

Study criteria: Healthy children who have no history of cholera vaccination or infection.

Contact email: ecc.vaccine@emory.edu

Contact Phone number: 404-727-4044

Study Description

The purpose of this study is to see if VAXCHORA, a cholera vaccine is safe and effective to use in children and adults. VAXCHORA is a vaccine approved by the Food and Drug Administration but it is only approved for people who are 18 to 64 years old.

Cholera is an infection of the intestines caused by a germ called Vibrio cholera, which can cause diarrhea.  In severe cases, the diarrhea can cause dehydration and death if untreated.  Cholera usually occurs in countries with poor sanitation and can affect travelers from the United States who are visiting these countries.

Who Can Participate?

Healthy children between 2-12 years of old.

What is involved?

The study involves 4-6 clinic visits at Emory Children’s Center, over about 6 months.  Each visit will last between 1-2 hours each. There will be 3 blood draws over the entire study. Children will receive one dose of oral cholera vaccine or an oral placebo on the first clinic visit.

What are the benefits?

Your child may not receive any benefits from being in this study. If your child receives the VAXCHORA vaccine, it might prevent a cholera infection. It is not guaranteed your child will receive the vaccine or that that vaccine will prevent a cholera infection. The information learned from this study may help prevent other children from getting cholera.

This study is free. To say thank you, families will be compensated for their time and participation.