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.
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.
Biological: Experimental Group
SARS-CoV-2 Inactivated Vaccine 600SU inactivated virus in 0·5 mL of aluminium hydroxide solution per injection
Other Name: CoronaVac
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.
Yongping Center for Diseases Control and Prevention
Dali, Yunnan, China
Investigator: XiaoQiang Liu
lxq7611@126.com
Xiaoqiang Liu, Doctor
15911568282
lxq7611@126.com