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Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children

Vaccine Reaction Clinical Trial

Official title:
A Phase III, Observer-Blind, Randomized, Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children Aged 12-17 Years in Indonesia

Clinical Trial Summary

A Phase III, Observer-blind, randomized, active-controlled prospective intervention study

Clinical Trial Description

This trial is randomized, prospective intervention study. A total of 1,050 subjects aged 12-17 years (COVID-19 vaccine naive) who are willing to participate in the study by signing the consent form, will be involved in this trial. The subjects will be divided into twostudy subsets, namely Main Study and Exploratory Study. Main Study for immunogenicity and safety evaluation. Exploratory Study for cellular immunity evaluation, ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05546502
Study type Interventional
Source PT Bio Farma
Contact Rini Mulia Sari, MD
Phone 0222033755
Email rini.mulia@biofarma.co.id
Status Recruiting
Phase Phase 3
Start date October 9, 2022
Completion date January 31, 2024
View Details
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