An Open Clinical Trial to Evaluate Immunogenicity and Safety of a Third Dose at Different Times After Two-dose of COVID-19 Vaccine (Vero Cell), Inactivated in the Elderly Aged 60 Years and Above
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Immunogenicity index-GMT of neutralizing antibodies
研究概览
简要总结
This is an open phase Ⅲ clinical trial of COVID-19 vaccine (Vero cell), inactivated manufactured by Sinovac Research & Development Co., Ltd.The purpose of this study is to evaluate Immunogenicity and safety of a third dose at different times after two-dose of COVID-19 vaccine (Vero cell), Inactivated in the Elderly Aged 60 years and above.
详细描述
This study is an open phase Ⅲ clinical trial. The main purpose of this study is to evaluate Immunogenicity and safety of a third dose at different times after two-dose of COVID-19 vaccine (Vero cell), Inactivated manufactured by Sinovac Research & Development Co., Ltd. in the elderly aged 60 years and above.A total of 400 subjects aged 60 years and above who had received two doses of COVID-19 vaccine(Vero Cell), inactivated manufactured by Sinovac Research & Development Co., Ltd. between 3 - 6 months ago (100 subjects for 3 months, 4 months, 5 months and 6 months,respectively) will be enrolled and receive a third dose of two-dose of COVID-19 vaccine (Vero cell), inactivated were enrolled.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects aged 60 years and above;
- •Provide legal identification;
- •Have completed two-dose of COVID-19 vaccine (Vero cell), inactivated manufactured by Sinovac Research& Development Co., Ltd. for 3~6 months（The interval between two doses was 21~35 days）；
- •Be able to understand and voluntarily sign the informed consent form and be willing to complete the study according to the research plan.
排除标准
- •History of SARS-CoV-2 infection(laboratory confirmed);
- •Those who have received COVID-19 vaccine from other manufacturers other than Sinovac Research& Development Co., Ltd., or who have received booster immunization with COVID-19 vaccine after two doses of COVID-19 vaccine (Vero cell),inactivated manufactured by Sinovac Research& Development Co., Ltd.;
- •History of serious adverse reactions to the vaccine or vaccine components, such as urticaria dyspnea and angioneuroedema;
- •Autoimmune disease or immunodeficiency/immunosuppression;
- •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;
- •Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months or plan to receive these treatments during the study period;
- •Receipt of blood products within in the past 3 months or plan to receive these treatments during the study period;
- •Receipt of other investigational drugs in the past 30 days;
- •Receipt of attenuated live vaccines in the past 14 days,or receipt of inactivated or subunit vaccines in the past 7 days;
- •Onset of various acute or chronic diseases within 7 days prior to the study;
- •Axillary temperature >37.0°C;
- •According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
研究组 & 干预措施
Experimental group 1 (3-month interval)
100 subjects who have received two doses of COVID-19 vaccine (Vero cell), Inactivated will receive a 3rd dose of the vaccine (3-month interval）.
干预措施: COVID-19 Vaccine (Vero cell), Inactivated (Biological)
Experimental group 2 (4-month interval)
100 subjects who have received two doses of COVID-19 vaccine (Vero cell), Inactivated will receive a 3rd dose of the vaccine (4-month interval）.
干预措施: COVID-19 Vaccine (Vero cell), Inactivated (Biological)
Experimental group 3 (5-month interval)
100 subjects who have received two doses of COVID-19 vaccine (Vero cell), Inactivated will receive a 3rd dose of the vaccine (5-month interval）.
干预措施: COVID-19 Vaccine (Vero cell), Inactivated (Biological)
Experimental group 4 (6-month interval)
100 subjects who have received two doses of COVID-19 vaccine (Vero cell), Inactivated will receive a 3rd dose of the vaccine (6-month interval）.
干预措施: COVID-19 Vaccine (Vero cell), Inactivated (Biological)
结局指标
主要结局
Immunogenicity index-GMT of neutralizing antibodies
时间窗: At 14 days after vaccination
GMT of neutralizing antibodies at 14 days after vaccination
Immunogenicity index- GMT of neutralizing antibodies
时间窗: At 28 days after vaccination
GMT of neutralizing antibodies at 28 days after vaccination
Safety index-Incidence of adverse reactions
时间窗: 0~28 days after vaccination
Incidence of adverse reactions 0\~28 days after vaccination
次要结局
- Immunogenicity index-GMT of neutralizing antibodies(Day 0 before vaccination and 180 days after vaccination)
- Immunogenicity index-4-fold increase rate of neutralizing antibodies(At 14 days and 28 days after vaccination.)
- Safety index-Incidence of adverse reactions(0~7 days after vaccination)
- Immunogenicity index-seropositive rate of neutralizing antibodies(Day 0 before vaccination and 14 days, 28 days and 180 days after vaccination)
- Safety index-Incidence of serious adverse events(6 months after vaccination)