A Randomized and Controlled Ⅳ Clinical Trial to Evaluate the Immunogenicity and Safety of COVID-19 Vaccine (Vero Cell), Inactivated Co-administrated With EV71 Vaccine (Vero Cell) in Children Aged 3-5 Years Old
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 520
- 试验地点
- 2
- 主要终点
- Immunogenicity index-Seroconversion rate of the neutralizing antibody to EV71
研究概览
简要总结
This study is a randomized and controlled phase Ⅳ clinical trial of the COVID-19 vaccine (Vero cell), Inactivated manufactured by Sinovac Research & Development Co., Ltd. The purpose of this study is to evaluate the immunogenicity and safety of COVID-19 vaccine (Vero cell), Inactivated co-administration with EV71 vaccine
详细描述
This study is a randomized and controlled phase Ⅳ clinical trial in children aged 3-5 years old. The purpose of this study is to evaluate the immunogenicity and safety of COVID-19 vaccine (Vero cell), Inactivated co-administration with EV71 vaccine.The COVID-19 vaccine was manufactured by Sinovac Research & Development Co., Ltd, and the EV71 vaccine was manufactured by Sinovac Biotech Co.A total of 520 subjects aged 3-5 years old will be enrolled.Subjects will be randomly divided into 2 groups in a ratio of 1:1.The experimental group is the combined immunization group, which will receive the first dose of COVID-19 vaccine and the second dose of COVID-19 vaccine and EV71 vaccine on day 28;Control group is the Non-combined immunization group , which will receive the first dose of COVID-19 vaccine on day 0 ，the first dose of EV71 vaccine on day 14 ，the second dose of COVID-19 vaccine on day 28 and the second dose of EV71 vaccine on day 42.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 3-5 years ;
- •The subject and/or guardian can understand and voluntarily sign the informed consent form
- •Proven legal identity;
排除标准
- •History of contact with a SARS-CoV-2 infection (positive in nucleic acid test) within 14 days;
- •History of multiple system inflammatory syndrome (MIS-C);
- •History of hand, foot and mouth disease, herpetic angina or EV71 vaccination;
- •History of asthma, history of allergy to the vaccine or vaccine components,or serious adverse reactions to the vaccine, such as urticaria, dyspnea,and angioedema;
- •Congenital malformations or developmental disorders, genetic defects,severe malnutrition, etc.;
- •Autoimmune disease (Systemic lupus erythematosus)or immunodeficiency / immunosuppression(HIV,history after organ transplantation)；
- •Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases,malignant tumors, etc.;
- •Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
- •Thyroid disease or history of thyroidectomy, asplenia,functional asplenia, asplenia or splenectomy resulting from any condition;
- •Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy,abnormal platelets) or obvious bruising or blood coagulation;
- •Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
- •History of drug abuse;
- •Receipt of blood products within in the past 3 months;
- •Receipt of other investigational drugs in the past 30 days;
- •Receipt of attenuated live vaccines in the past 14 days;
- •Receipt of inactivated or subunit vaccines in the past 7 days;
- •Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
- •Axillary temperature >37.0°C;
- •The subjects participated in other clinical trials during the follow-up period, or will be planned within 3 months;
- •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-Seroconversion rate of the neutralizing antibody to EV71
时间窗: Day 28 after the second dose of EV71 vaccine
Seroconversion rate of the neutralizing antibody to EV71 at day 28 after the second dose of EV71 vaccine
Immunogenicity index-Seroconversion rate of the neutralizing antibody to live SARS-CoV-2
时间窗: Day 28 after the second dose of COVID-19 vaccine
Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose of COVID-19 vaccine
次要结局
- Immunogenicity index-Seropositivity rate of the neutralizing antibody to live SARS-CoV-2(Day 28 after the second dose of COVID-19 vaccine)
- Immunogenicity index- GMT of the neutralizing antibody to live SARS-CoV-2(Day 28 after the second dose of COVID-19 vaccine)
- Safety index-Incidence of the adverse reactions(From day 0 to 28 days after the last dose)
- Immunogenicity index-GMI of the neutralizing antibody to live SARS-CoV-2(Day 28 after the second dose of COVID-19 vaccine)
- Immunogenicity index-Seropositive rate of the neutralizing antibody to EV71(Day 28 after the second dose of EV71)
- Safety index-Incidence of the serious adverse events and the adverse events of special interest(From the beginning vaccination to 6 months after the last dose)
- Immunogenicity index-GMT of the neutralizing antibody to EV71(Day 28 after the second dose of EV71)
- Immunogenicity index-GMI of the neutralizing antibody to EV71(Day 28 after the second dose of EV71)