NCT04918797

COVAXIN in a Pediatric Cohort

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.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 525 (actual)
• Sponsor: Bharat Biotech International Limited · Industry
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• SARS-CoV2 Infection

Interventions

Type	Name	Description
BIOLOGICAL	COVAXIN	Whole-Virion Inactivated SARS-CoV-2 Vaccine (COVAXIN®)

Timeline

• Start date: 2021-05-26
• Primary completion: 2021-08-15
• Completion: 2022-01-25
• First posted: 2021-06-09
• Last updated: 2022-08-18

Locations

7 sites across 1 country: India