Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bavarian Nordic
With
Emergent BioSolutions
This is a randomized, placebo-controlled, double-blind, single-crossover study with three age cohorts and two treatment groups within each cohort.
Age
2–17
Sex
ALL
Healthy volunteers
Accepted
You may be eligible 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 be 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)
Clareo Health | VAXCHORA Pediatric Study to Assess Safety and Immunogenicity
