Cochrane COVID-19 Study Register
Study record
NCT04918797First Published: 2021 Jun 10Updated Date: 2021 Jun 10

A Phase II/III, Open Label, Multicenter Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the Whole-Virion Inactivated SARS-CoV-2 Vaccine (COVAXIN®) in Healthy Volunteers Ages ≤18 to ≥ 2 Years

  1. Study Type
  2. Interventional
  1. Study Aim
  2. Prevention
  1. Study Design
  2. Single Arm/Controlled Before After
  1. Intervention Assignment
  2. Not Applicable
Reference record

COVAXIN in a Pediatric Cohort

NCT04918797
Trial registry record
No Results
The study is designed to evaluate the safety, reactogenicity and immunogenicity of three groups ages ≤18 - >12, ≤12 ->6, ≤ 6 - >2 years of healthy volunteers who receive two doses of the whole virion inactivated SARS-CoV-2 virus vaccine (COVAXIN®) 28 days apart. Data will be un-blinded to the third party bio-statistician and an interim analysis will be performed on day 56 for Immunogenicity, Safety and submitted to CDSCO