Safety of an Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Children and Adolescents
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
This study is a multi-center and open design, phase Ⅳ clinical trial in population aged 317 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 35years，1200 subjects aged 611 years,1200 subjects aged 1217 years.
And subjects will receive two doses of vaccine on day 0 and day 28.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Biological: Experimental Group
SARS-CoV-2 Inactivated Vaccine 600SU inactivated virus in 0·5 mL of aluminium hydroxide solution per injection
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Safety index 1-incidence of adverse reactions [Within 0~7 days after each dose]
Incidence rate of adverse reactions within 0~7 days after each dose in all populations.
Secondary Outcome Measures
- Safety index 2-incidence of adverse reactions [Within 0-28 days after each dose vaccination]
Incidence rate of adverse reactions within 0~28 days after each dose in all populations
- Safety index 3-incidence of adverse reactions [Within 0~7 days after each dose vaccination]
Incidence of adverse reactions within 0~7 days after each dose in each age group
- Safety index 4-incidence of adverse reactions [Within 0~28 days after each dose vaccination]
Incidence rate of adverse reactions within 0~28 days after each dose in each age group
- Safety index 5-incidence of adverse reactions [Within 0~7 days after each dose vaccination]
Incidence of adverse reactions within 0~7 days after each dose in the population with pre-existing disease.
- Safety index 6-incidence of adverse reactions [Within 0~28 days after each dose vaccination]
Incidence of adverse reactions within 0~28 days after each dose in the population with pre-existing disease.
Eligibility Criteria
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;
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Population aged 3~17 years ;
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The subjects can understand and voluntarily sign the informed consent form and participate in the follow-up;
Exclusion Criteria:
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History of severe allergy to the vaccine such as acute allergic reaction,angioedema and dyspnea ;
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Severe neurological disease such as Myelitis transverse,Guillain-Barre Syndrome and demyelinating disorders;
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Acute disease,acute onset of chronic disease and severe chronic diseases.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Yongping Center for Diseases Control and Prevention | Dali | Yunnan | China | 650022 |
Sponsors and Collaborators
- Sinovac Life Sciences Co., Ltd.
Investigators
- Principal Investigator: 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, Fujian Provincial Center for Disease Control and Prevention
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PRO-nCOV-MA4008