Safety of an Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Children and Adolescents
- Conditions
- COVID-19
- Interventions
- Biological: Experimental Group
- Registration Number
- NCT04992208
- Lead Sponsor
- Sinovac Life Sciences Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31041
- 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;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental Group 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 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.
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 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
Trial Locations
- Locations (1)
Yongping Center for Diseases Control and Prevention
🇨🇳Dali, Yunnan, China