To Evaluate Safety of Oral Cholera Vaccine Hillchol® (BBV131)

Summary

A Phase III randomized, modified double-blind, multi-centric, comparative study, to evaluate the non-inferiority of immunogenicity and safety of single strain oral cholera vaccine Hillchol® (BBV131) to the comparator vaccine Shanchol™ along with lot-to-lot consistency of Hillchol®(BBV131). Study Population: A total of 1800 participants will be enrolled in three descending age groups(Group I- ≥18, Group II: ≥5 to \<18 and Group III: ≥1 to \<5). In each group,600 participants will be enrolled and will receive two doses of Hillchol® (BBV131) vaccine two weeks apart.

Timeline

Start

2023-02-04

Primary completion

2023-03

Completion

2023-08

Drugs

Indications