VAXCHORA Pediatric Study to Assess Safety and Immunogenicity
Condition: Cholera (Disorder)
MeSH terms: Cholera
Intervention: VAXCHORA (Cholera Vaccine, Live, Oral); Placebo
Intervention description: 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.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: This is a randomized, placebo-controlled, double-blind, single-crossover study with three age cohorts and two treatment groups within each cohort.
The main study consists of a screening period of 30 days, a treatment period from Day 1 to Day 29, and a follow-up period through Day 181. Cohort 1 has an optional sub-study consisting of a long-term follow-up period through Day 730.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: The study will be conducted as a double-blind study through 181, where neither the sponsor, the statistical team, study volunteer subjects, nor clinical site personnel (except for the unblinded administration staff) will know subjects' treatment assignment. Once each subject has reached their Day 181 visit they will be individually unblinded.
Enrollment: 550.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        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)