A Randomized, Double-Blinded Clinical Trial to Evaluate the Immunogenicity Using Additional Dose of Medium-dosage or High-dosage COVID-19 Vaccine (Vero Cell), Inactivated in Populations Who Have Completed Primary Immunization 5-9 Months
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain)
研究概览
简要总结
This is a randomized, double-blinded, phase Ⅳ clinical trial of COVID-19 vaccine (Vero cell), Inactivated manufactured by Sinovac Life Sciences Co. , Ltd. The purpose of this study is to evaluate the safety and immunogenicity of booster vaccination using high-dosage or medium-dosage of COVID-19 vaccine (Vero cell), Inactivated in populations who have completed primary immunization 5-9 months
详细描述
This study a randomized, double-blinded, phase Ⅳ clinical trial of COVID-19 vaccine (Vero cell), Inactivated.The purpose of this study is to evaluate the safety and immunogenicity of booster vaccination using high-dosage or medium-dosage of COVID-19 vaccine (Vero cell), Inactivated in populations who have completed primary immunization 5-9 months.A total of 340 subjects who have completed primary immunization using two-dose Coronavac® 5-9 months were be enrolled.All of subjects were be randomly divided into two groups in a 1:1 ratio to receive high-dosage or medium-dosage of COVID-19 vaccine (Vero cell), Inactivated.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participants aged 18 years and above;
- •Proven legal identity;
- •The subjects can understand and voluntarily sign the informed consent form and be willing to complete the study in accordance with the study plan;
- •Have received two doses of inactivated COVID-19 vaccine (CoronaVac®) manufactured by Sinovac Research & Development Co., Ltd and that is currently 5-9 months after the second dose.
排除标准
- •History of SARS-CoV-2 infection(laboratory confirmed);
- •Have received three and more doses of inactivated COVID-19 vaccine;
- •Known allergy to vaccines or vaccine ingredients, and serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema;
- •Autoimmune disease such as systemic lupus erythematosus or immunodeficiency / immunosuppression such as AIDS, post-transplant;
- •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;
- •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 alcohol or 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;
- •Acute diseases or acute exacerbation of chronic diseases within 7 days prior to booster vaccination;
- •Axillary temperature >37.0°C;
- •Participated in other clinical trials prior to enrollment and during the followup period, or planned to participate in other clinical trials during the clinical trial period;
- •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 neutralizing antibodies(CZ02 strain)
时间窗: 14 days after the booster dose vaccination
GMT of neutralizing antibodies(CZ02 strain) 14 days after the booster dose vaccination
次要结局
- Immunogenicity index-Seropositivity rate of neutralizing antibodies(CZ02 strain)(14 days after the booster dose vaccination)