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Efficacy, Immunogenicity and Safety of Inactivated Vaccine (Coronavac) Against SARS-COV2 in Children and Adolescents

NCT05225285 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1120

Last updated 2022-02-04

No results posted yet for this study

Summary

To evaluate the efficacy and safety of vaccinating children and adolescents, aged 3 to 17 years, with a two-dose schedule of the inactivated vaccine (Coronavac) against SARS-Cov-2.

Conditions

Interventions

BIOLOGICAL

Inactivated Coronavac/Butantan vaccine

Inactivated Coronavac/Butantan vaccine in 2 doses of 0.5 ml, 4 weeks apart

BIOLOGICAL

BNT162b2 (Pfizer)

BNT162b2 (Pfizer) vaccine in 2 doses of 0.1 ml or 0.30 ml (according to age group), 4 weeks apart

Sponsors & Collaborators

  • Centro de Pesquisas René Rachou

    collaborator OTHER_GOV

  • Butantan Institute

    collaborator OTHER_GOV

  • Secretaria de Estado da Saúde do Espírito Santo - SESA

    collaborator UNKNOWN

  • Federal University of Espirito Santo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-21
Primary Completion
2022-06-21
Completion
2023-03-21

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

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 NCT05225285 on ClinicalTrials.gov