Safety Observation of the Inactivated SARS-CoV-2 Vaccine (Vero Cell) in Population Aged 3~17 Years : A Multicenter,Open-label Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 31,041
- 试验地点
- 1
- 主要终点
- Safety index 1-incidence of adverse reactions
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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;
排除标准
- •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.
结局指标
主要结局
Safety index 1-incidence of adverse reactions
时间窗: Within 0~7 days after each dose
Incidence rate of adverse reactions within 0\~7 days after each dose in all populations.
次要结局
- Safety index 2-incidence of adverse reactions(Within 0-28 days after each dose vaccination)
- Safety index 3-incidence of adverse reactions(Within 0~7 days after each dose vaccination)
- Safety index 6-incidence of adverse reactions(Within 0~28 days after each dose vaccination)
- Safety index 5-incidence of adverse reactions(Within 0~7 days after each dose vaccination)
- Safety index 4-incidence of adverse reactions(Within 0~28 days after each dose vaccination)