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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safety Observation of the Inactivated SARS-CoV-2 Vaccine (Vero Cell) in Population Aged 3 17 Years : A Multicenter,Open-label Study

Conditions
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COVID-19

Intervention / Treatment
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* Biological: Experimental Group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>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<br>* SARS-CoV-2 Inactivated Vaccine 600SU inactivated virus in 0·5 mL of aluminium hydroxide solution per injection<br>* Other names: CoronaVac;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety index 2-incidence of adverse reactions | Incidence rate of adverse reactions within 0 28 days after each dose in all populations | Within 0-28 days after each dose vaccination | 
| Safety index 3-incidence of adverse reactions | Incidence of adverse reactions within 0 7 days after each dose in each age group | Within 0 7 days after each dose vaccination | 
| Safety index 4-incidence of adverse reactions | Incidence rate of adverse reactions within 0 28 days after each dose in each age group | Within 0 28 days after each dose vaccination | 
| Safety index 5-incidence of adverse reactions | Incidence of adverse reactions within 0 7 days after each dose in the population with pre-existing disease. | Within 0 7 days after each dose vaccination | 
| Safety index 6-incidence of adverse reactions | Incidence of adverse reactions within 0 28 days after each dose in the population with pre-existing disease. | Within 0 28 days after each dose vaccination |