COVAXIN in a Pediatric Cohort

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

Study design: 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. A total sample size of 525 healthy volunteers. 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. Group1: A total of 175 healthy volunteers ages ≤18->12, years will be enrolled in this group and will receive two doses of BBV152 vaccine through intramuscular route on Day 0 and Day 28+2. Group 2: A total of 175 healthy volunteers ages ≤12->6, years will be enrolled in this group and will receive two doses of BBV152 vaccine through intramuscular route on Day 0 and Day 28+2. Group 3: A total of 175 healthy volunteers ages ≤6-> 2 years will be enrolled in this group and will receive two doses of BBV152 vaccine through intramuscular route on Day 0 and Day 28+2. 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. Immunogenicity analysis: A total of 5 ml of blood is collected at days 0, 28+2, 56±7, 118±7 and 208±7. SARS-CoV-2 test will be conducted at the time of screening using RT-PCR and ELISA method. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04918797
Study type	Interventional
Source	Bharat Biotech International Limited
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	May 26, 2021
Completion date	January 25, 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

COVAXIN in a Pediatric Cohort — COVAXIN-Peds

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms