VAXCHORA Pediatric Study to Assess Safety and Immunogenicity

Exclusion Criteria

• •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)