VAXCHORA Pediatric Study to Assess Safety and Immunogenicity
Completed · Phase 4 · Has a placebo group
Conditions studied: Cholera (Disorder)
In brief
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.
Key facts
- Study ID
- NCT03220737
- Run by
- Bavarian Nordic
- People needed
- 550
- Starts
- 2017-07-21
- Expected to finish
- 2020-03-06
- Last updated by the study team
- 2023-06-28
Who can join
Age: 2 and older, up to 17. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Male or Female
- Between 2 and <18 years of age on Day 1
- In general good health
- Able and willing to provide informed assent for study participation
- Primary caregiver is able and willing to provide informed consent for study participation
- (for females of childbearing potential) Using an acceptable method of contraception through Day 29
You may not qualify if…
- Current acute gastrointestinal illness or loose stools within 3 days of Day 1 visit
- Current acute febrile illness
- History of cholera infection
- History of cholera vaccination
- History of severe allergic reaction (e.g. anaphylaxis) to any ingredient of VAXCHORA
- Congenital or acquired immunodeficiency
- Pregnancy (for females of childbearing potential)
- Any other condition that, in the opinion of the Investigator, creates an unacceptable risk to the subject
- Any other condition that, in the opinion of the Investigator, will interfere with the conduct of the study or the validity of the data
- Duration of >2 weeks of abnormal stool pattern, defined as <3 stools per week or >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)
Where it is running
- Emory University — Atlanta, Georgia, United States
- Johnson County Clin-Trials, Inc. — Lenexa, Kansas, United States
- Heartland Research Associates, LLC — Wichita, Kansas, United States
- 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
Full record on ClinicalTrials.gov
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