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Safety and Immunogenicity of COVID-19 Vaccine, Inactivated in Healthy Population Aged From 3 to 11 Years

COVID-19 Clinical Trial

Official title:
An Open-labelled, Bridging Phase Ⅲ Clinical Trial to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine in Healthy Population Aged From 3 to 11 Years

Clinical Trial Summary

This is an open-labelled, bridging phase Ⅲ clinical trial of COVID-19 Vaccine manufactured by Sinovac Research & Development Co., Ltd. The main purpose of this study is to evaluate the superiority of the COVID-19 Vaccine in healthy population aged from 3 to 11 years against that in adults aged 18-26 years.

Clinical Trial Description

This study is a single-center, open-labelled, bridging phase Ⅲ clinical trial of COVID-19 Vaccine.The main purpose of this study is to evaluate the superiority of the COVID-19 Vaccine in healthy population aged from 3 to 11 years against that in adults aged 18-26 years.This study (PRO-nCOV-3002-1) will be used as a sub-trial of the Phase Ⅲ global multi-center clinical trial in children and adolescents(PRO-nCOV-3002) to provide safety and immunogenicity data.A total of 1000 healthy children aged 3-11 years will be enrolled ,including 500 children aged 3-5 years and 500 children aged 6-11 years.All subjects will receive 2 doses of experimental vaccine (600SU) with an interval of 28 days,and adverse reactions/events will be collected from all subjects after each dose and SAE and AESI monitoring will be completed from the beginning of vaccination to 6 and 12 months after full vaccination to evaluate the safety of the vaccine.About 3.0-3.5ml of venous blood will be collected from all subjects before immunization, 28 days after the whole immunization, 6 months after the whole immunization and 12 months after the whole immunization. Neutralizing antibody and S antibody will be detected to evaluate the immunogenicity and immune persistence of the vaccine. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05137418
Study type Interventional
Source Sinovac Biotech Co., Ltd
Contact
Status Completed
Phase Phase 3
Start date November 27, 2021
Completion date January 27, 2023
View Details
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