Clinical trial NCT04992208: Safety of an Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Children and Adolescents
Official title: Safety Observation of the Inactivated SARS-CoV-2 Vaccine (Vero Cell) in Population Aged 3~17 Years : A Multicenter,Open-label Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: COVID-19
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-08-05
Enrollment: 31041
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Safety index 1-incidence of adverse reactions
timeFrame: Within 0~7 days after each dose
Secondary outcomes:
measure: Safety index 2-incidence of adverse reactions
timeFrame: Within 0-28 days after each dose vaccination
measure: Safety index 3-incidence of adverse reactions
timeFrame: Within 0~7 days after each dose vaccination
measure: Safety index 4-incidence of adverse reactions
timeFrame: Within 0~28 days after each dose vaccination
measure: Safety index 5-incidence of adverse reactions
timeFrame: Within 0~7 days after each dose vaccination
measure: Safety index 6-incidence of adverse reactions
timeFrame: Within 0~28 days after each dose vaccination
Other outcomes:
Locations:
city: Dali
country: China
facility: Yongping Center for Diseases Control and Prevention
state: Yunnan
Study officials:
affiliation: Yunnan Provincial Center for Disease Control and Prevention
name: Xiaoqiang Liu, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Liaoning Provincial Center for Disease Control and Prevention
name: Xing Fang
role: PRINCIPAL_INVESTIGATOR
affiliation: HeilongjiangProvincial Center for Disease Control and Prevention
name: Zhaodan Sun
role: PRINCIPAL_INVESTIGATOR
affiliation: Hefei Provincial Center for Disease Control and Prevention
name: Fubing Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Disease Control and Prevention, Fujian
name: Dongjuan Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: Jiangxi Provincial Center for Disease Control and Prevention
name: Shicheng Guo
role: PRINCIPAL_INVESTIGATOR
affiliation: Hubei Provincial Center for Disease Control and Prevention
name: Yeqing Tong
role: PRINCIPAL_INVESTIGATOR
affiliation: Guangxi Center for Disease Control and Prevention
name: Qiuyun Deng
role: PRINCIPAL_INVESTIGATOR
affiliation: Chongqing Center for Disease Control and Prevention
name: Qing Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Guizhou Provincial Center for Disease Control and Prevention
name: Ruizhi Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: Gansu Provincial Center for Disease Control and Prevention
name: Xiaoshu Zhang
role: PRINCIPAL_INVESTIGATOR
References: