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COVAXIN in a Pediatric Cohort

NCT04918797 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 525

Last updated 2022-08-18

No results posted yet for this study

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.

Conditions

  • SARS-CoV2 Infection

Interventions

BIOLOGICAL

COVAXIN

Whole-Virion Inactivated SARS-CoV-2 Vaccine (COVAXIN®)

Sponsors & Collaborators

  • Bharat Biotech International Limited

    lead INDUSTRY

Principal Investigators

  • Dr.Vasant Khalatkar, MBBS,MD · Meditrina Institute of Medical Sciences,Nagpur

  • Dr.V.N Tripathi, MBBS,MD · Prakhar Hospital Pvt Ltd.,Kanpur

  • Dr Padmavathi I V, MBBS,MD · Victoria Government Hospital

  • Dr.Lokesh Kumar Tiwari, MBBS,DNB · All India Institute of Medical Scienes,Patna

  • Dr.Jai Prakash Narayan, MBBS,MD · JLN Medical college,Ajmer

  • Dr Mirza Nizam Baig, MBBS,MD · Pranam Hospitals Hyderabad

  • Dr Prashanth Siddiah, MBBS,MD · Cheluvambha Hospital,Mysore

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-26
Primary Completion
2021-08-15
Completion
2022-01-25

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04918797 on ClinicalTrials.gov