Immunogenicity of an Inactivated COVID-19 Vaccine for Prevention of COVID-19 in Population Aged 3-11 Years
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 395
- 试验地点
- 1
- 主要终点
- Immunogenicity index-GMT of the neutralizing antibody to SARS-CoV-2
研究概览
简要总结
This study is an open phase 4 clinical trial of an inactivated COVID-19 vaccine (CoronaVac) manufactured by Sinovac Research and Development Co., Ltd. The purpose of this study is to evaluate the immunogenicity of the CoronaVac in healthy children aged 3-11 years old.
详细描述
This study is an open phase 4 clinical trial to evaluate the immunogenicity of an inactivated COVID-19 vaccine(CoronaVac)in healthy children aged 3-11 years old.A total of 400 healthy subjects who have received two doses of inactivated COVID-19 vaccine(CoronaVac) manufactured by Sinovac Research & Development Co., Ltd and is currently 28-42 days after the second dose will be enrolled, including 200 subjects aged 3-5 years and 200 subjects aged 6-11 years old.All of subjects will be collected 3ml venous blood to evaluate the immunogenicity of the CoronaVac.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have received two doses of inactivated COVID-19 vaccine(CoronaVac) manufactured by Sinovac Research & Development Co., Ltd and is currently 28-42 days after the second dose;
- •The subjects and/or guardians can understand and voluntarily sign the informed consent form (for subjects aged 8 years, both subjects and guardians need to sign the informed consent form);
- •The subjects and their legal guardians voluntarily participate the study and comply with the study procedure to collect 3ml venous blood;
- •Proven legal identity.
排除标准
- •Haven't received two doses of inactivated COVID-19 vaccine(CoronaVac);
- •Have received COVID-19 vaccines from other manufacturers;
- •The interval between blood collection and the second dose is less than 28 days or more than 42 days;
- •The subjets and their legal guardians can't cooperate to complete 3ml venous blood collection.
- •According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
结局指标
主要结局
Immunogenicity index-GMT of the neutralizing antibody to SARS-CoV-2
时间窗: Day 28(+14 days) after the second dose of vaccine
GMT of the neutralizing antibody to SARS-CoV-2 day 28(+14 days) after the second dose of vaccine
Immunogenicity index-Seropositivity rate of the neutralizing antibody to SARS-CoV-2
时间窗: Day 28(+14 days) after the second dose of vaccine
Seropositivity rate of the neutralizing antibody day 28(+14 days) after the second dose of vaccine
次要结局
未报告次要终点