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Safety of an Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Children and Adolescents

NCT04992208 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 31041

Last updated 2023-09-25

No results posted yet for this study

Summary

This study is a multi-center and open design, phase Ⅳ clinical trial of an inactivated SARS-CoV-2 vaccine (CoronaVac) manufactured by Sinovac Research and Development Co., Ltd.The purpose of this study is to evaluate the safety of the SARS-CoV-2 Inactivated vaccine in population aged 3\~17 years and in people with pre-existing disease to provide reference for improving the immunization strategy of COVID-19 vaccine.

Conditions

Interventions

BIOLOGICAL

Experimental Group

SARS-CoV-2 Inactivated Vaccine 600SU inactivated virus in 0·5 mL of aluminium hydroxide solution per injection

Sponsors & Collaborators

  • Sinovac Life Sciences Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xiaoqiang Liu, Doctor · Yunnan Provincial Center for Disease Control and Prevention

  • Xing Fang · Liaoning Provincial Center for Disease Control and Prevention

  • Zhaodan Sun · HeilongjiangProvincial Center for Disease Control and Prevention

  • Fubing Wang · Hefei Provincial Center for Disease Control and Prevention

  • Dongjuan Zhang · Center for Disease Control and Prevention, Fujian

  • Shicheng Guo · Jiangxi Provincial Center for Disease Control and Prevention

  • Yeqing Tong · Hubei Provincial Center for Disease Control and Prevention

  • Qiuyun Deng · Guangxi Center for Disease Control and Prevention

  • Qing Wang · Chongqing Center for Disease Control and Prevention

  • Ruizhi Zhang · Guizhou Provincial Center for Disease Control and Prevention

  • Xiaoshu Zhang · Gansu Provincial Center for Disease Control and Prevention

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-07-24
Primary Completion
2023-03-24
Completion
2023-08-31

Countries

  • China

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 NCT04992208 on ClinicalTrials.gov