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

NCT04992208 | Completed Phase 4

• 1 other identifier: PRO-nCOV-MA4008
• Study Type: interventional
• Target: 31,041
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Safety index 1-incidence of adverse reactions

  Incidence rate of adverse reactions within 0\~7 days after each dose in all populations.

  Within 0~7 days after each dose

Secondary Outcomes (5)

• Safety index 2-incidence of adverse reactions

  Within 0-28 days after each dose vaccination

• Safety index 3-incidence of adverse reactions

  Within 0~7 days after each dose vaccination

• Safety index 4-incidence of adverse reactions

  Within 0~28 days after each dose vaccination

• Safety index 5-incidence of adverse reactions

  Within 0~7 days after each dose vaccination

• Safety index 6-incidence of adverse reactions

  Within 0~28 days after each dose vaccination

Study Arms (1)

Experimental Group

EXPERIMENTAL

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.

Biological: Experimental Group

Interventions

Experimental Group BIOLOGICAL

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

Also known as: CoronaVac

Experimental Group

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sinovac Life Sciences Co., Ltd.: lead

Study Sites (1)

Yongping Center for Diseases Control and Prevention

Dali, Yunnan, 650022, China

Location

Related Publications (1)

• 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.

  PMID: 36658045 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

sinovac COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Xiaoqiang Liu, Doctor

  Yunnan Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Xing Fang

  Liaoning Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Zhaodan Sun

  HeilongjiangProvincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Fubing Wang

  Hefei Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Dongjuan Zhang

  Center for Disease Control and Prevention, Fujian

  PRINCIPAL INVESTIGATOR

• Shicheng Guo

  Jiangxi Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Yeqing Tong

  Hubei Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Qiuyun Deng

  Guangxi Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Qing Wang

  Chongqing Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Ruizhi Zhang

  Guizhou Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Xiaoshu Zhang

  Gansu Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 5, 2021
• Study Start: July 24, 2021
• Primary Completion: March 24, 2023
• Study Completion: August 31, 2023
• Last Updated: September 25, 2023

Record last verified: 2021-08

Locations

CN (1)