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

NCT ID: NCT04992208

Last Updated: 2023-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 31041 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-24
• Study Completion Date: 2023-08-31

Brief 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.

Detailed Description

This study is a multi-center and open design, phase Ⅳ clinical trial in population aged 3~17 years . The experimental vaccine will be manufactured by Sinovac Research and Development Co.,Ltd.The study is planned to be carried out in 11 provinces from August 2021 to December 2022, including Liaoning, Heilongjiang, Anhui, Fujian, Jiangxi, Hubei, Guangxi, Chongqing, Guizhou, Yunnan and Gansu. Each province will serve as a research center, and each research center will select the corresponding research site.A total of 33000 subjects including patients with pre-existing will be enrolled with 3000 for each research center, including 600 subjects aged 3~5years，1200 subjects aged 6~11 years,1200 subjects aged 12~17 years.

And subjects will receive two doses of vaccine on day 0 and day 28.

Conditions

COVID-19

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Experimental Group

All of the participants(N=33000) will receive two doses inactivated SARS-CoV-2 vaccine . Vaccine will given by intramuscular injection on day 0 and day 28.

Group Type: EXPERIMENTAL

Experimental Group

Intervention Type: BIOLOGICAL

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

Interventions

Experimental Group

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

Intervention Type: BIOLOGICAL

Other Intervention Names

CoronaVac

Eligibility Criteria

Inclusion Criteria

• Have not received any COVID-19 vaccine in the past or at least one dose of CoronaVac manufactured by Sinovac Research and Development Co.,Ltd;
• Population aged 3~17 years ;
• The subjects can understand and voluntarily sign the informed consent form and participate in the follow-up;

Exclusion Criteria

• History of severe allergy to the vaccine such as acute allergic reaction,angioedema and dyspnea ;
• Severe neurological disease such as Myelitis transverse,Guillain-Barre Syndrome and demyelinating disorders;
• Acute disease,acute onset of chronic disease and severe chronic diseases.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sinovac Life Sciences Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaoqiang Liu, Doctor

Role: PRINCIPAL_INVESTIGATOR

Yunnan Provincial Center for Disease Control and Prevention

Xing Fang

Role: PRINCIPAL_INVESTIGATOR

Liaoning Provincial Center for Disease Control and Prevention

Zhaodan Sun

Role: PRINCIPAL_INVESTIGATOR

HeilongjiangProvincial Center for Disease Control and Prevention

Fubing Wang

Role: PRINCIPAL_INVESTIGATOR

Hefei Provincial Center for Disease Control and Prevention

Dongjuan Zhang

Role: PRINCIPAL_INVESTIGATOR

Center for Disease Control and Prevention, Fujian

Shicheng Guo

Role: PRINCIPAL_INVESTIGATOR

Jiangxi Provincial Center for Disease Control and Prevention

Yeqing Tong

Role: PRINCIPAL_INVESTIGATOR

Hubei Provincial Center for Disease Control and Prevention

Qiuyun Deng

Role: PRINCIPAL_INVESTIGATOR

Guangxi Center for Disease Control and Prevention

Qing Wang

Role: PRINCIPAL_INVESTIGATOR

Chongqing Center for Disease Control and Prevention

Ruizhi Zhang

Role: PRINCIPAL_INVESTIGATOR

Guizhou Provincial Center for Disease Control and Prevention

Xiaoshu Zhang

Role: PRINCIPAL_INVESTIGATOR

Gansu Provincial Center for Disease Control and Prevention

Locations

Yongping Center for Diseases Control and Prevention

Dali, Yunnan, China

Countries

China

References

Yang H, Li Z, Zhang R, Guo S, Wang B, Fang X, Zhang D, Zhang X, Tong Y, Wang Q, Deng Q, Sun Z, Liu X, Gao Y. Safety of primary immunization using inactivated SARS-CoV-2 vaccine (CoronaVac(R)) among population aged 3 years and older in a large-scale use: A multi-center open-label study in China. Vaccine. 2023 Feb 10;41(7):1354-1361. doi: 10.1016/j.vaccine.2023.01.020. Epub 2023 Jan 13.

Reference Type: DERIVED

PMID: 36658045 (View on PubMed)

Other Identifiers

PRO-nCOV-MA4008

Identifier Type: -

Identifier Source: org_study_id