evidence: Study Design: Study 1 was a randomized, double-blind, saline placebo-controlled safety and immunogenicity study conducted in the US and Australia. A total of 3146 subjects 18 through 45 years of age not previously exposed to cholera were randomized 8:1 to receive 1 dose of VAXCHORA or placebo.1 [...] Study Design: Study 5 was a randomized, double-blind, saline placebo-controlled safety and immunogenicity study conducted in the US. A total of 550 subjects 2 through 17 years of age not previously exposed to cholera were randomized 6:1 to receive one dose of VAXCHORA or placebo. Randomization was stratified by age into 3 cohorts: Cohort 1: 12 to <18 years of age; Cohort 2: 6 to <12 years of age; Cohort 3: 2 to <6 years of age.1 [...] The safety of VAXCHORA in children was evaluated in a randomized, placebo-controlled, multicenter clinical trial that included a total of 543 children 2 through 17 years of age. Randomization was stratified by age, and children were enrolled in 3 separate age cohorts: 12-<18 years (Cohort 1), 6 -<12 years (Cohort 2), and 2-<6 years (Cohort 3).