A Randomized, Double-Blinded Clinical Trial, to Evaluate the Non-inferiority of the Commercial Scale Inactivated SARS-CoV-2 Vaccine Against That of the Pilot Scale Among Adults Aged 26-45 Years, and the Open-labelled, Bridging Non-inferiority of the Vaccine Induced Immunogenicity in Elderly Against That in Adults
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,040
- 试验地点
- 1
- 主要终点
- Immunogenicity index-geometric mean titer(GMT) of neutralizing antibody
研究概览
简要总结
This study is a randomized, double-blinded clinical Trial, to evaluate the non-inferiority of the commercial scale Inactivated SARS-CoV-2 vaccine against that of the pilot scale among adults aged 26-45 years, and the open-labelled, bridging non-inferiority of the vaccine induced immunogenicity in elderly against that in adults.
详细描述
This study is a randomized, double-blinded clinical Trial, to evaluate the non-inferiority of the commercial scale Inactivated SARS-CoV-2 vaccine against that of the pilot scale among adults aged 26-45 years, and the open-labelled, bridging non-inferiority of the vaccine induced immunogenicity in elderly against that in adults. The experimental vaccine was manufactured by Sinovac Research & Development Co.,Ltd. Totally 1040 subjects，including: 130 subjects aged 18~25 years; 520 subjects aged 26~45 years, with 260 in each group; 130 subjects aged 46~59 years; 260 subjects aged ≥60 years.
Subjects will be assigned to receive two doses of medium-dosage vaccine on the schedule of 0,14.
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)
盲法说明
The first part of the study is a double-blinded trial, the second part is a open-label research.
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 adults aged 18-59 or elderly aged ≥60 years;
- •Proven legal identity.
排除标准
- •Travel/residence history of communities with reported cases within 14 days before trial;
- •History of exposure to Novel Coronavirus infection (nucleic acid positive) within 14 days prior to the trial;
- •Exposed to patients with fever or respiratory symptoms from communities with reported cases within 14 days prior to the trial;
- •Two or more cases of fever and/or respiratory symptoms in a small area such as home, office, school and class within 14 days prior to the trial;
- •History of SARS-CoV-2 infection;
- •History of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema;
- •Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
- •Autoimmune disease or immunodeficiency/immunosuppression;
- •Patients with serious chronic diseases, serious cardiovascular diseases, uncontrolled hypertension and diabetes, liver and kidney diseases, malignant tumors, etc.;
- •Serious neurological disorder (epilepsy, convulsions or convulsions) or psychosis;
- •History of thyroid disease or thyroidectomy, absence of spleen, functional absence of spleen, and absence of spleen or splenectomy caused by any circumstance;
- •Coagulation dysfunction (such as coagulation factor deficiency, coagulation disease, platelet abnormality) or obvious bruising or coagulation disorder diagnosed by doctors;
- •Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, and surface corticosteroid therapy for acute non-complicated dermatitis) in the past 6 months;
- •Long history of alcohol or drug abuse;
- •Received blood products within 3 months prior to receiving the vaccine;
- •Received other research drugs within 30 days prior to receiving the vaccine;
- •Received live attenuated vaccine within 14 days prior to receiving the vaccine;
- •Received subunit or inactivated vaccine within 7 days prior to receiving the vaccine;
- •Onset of various acute or chronic diseases within 7 days prior to the study;
- •Axillary temperature of >37.0℃ before inoculation of the vaccine;
- •Those who are already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to become pregnant within 2 months;
- •In the opinion of the investigator, the participants had any other factors that made them unsuitable to participate in the clinical trial.
结局指标
主要结局
Immunogenicity index-geometric mean titer(GMT) of neutralizing antibody
时间窗: Day 14 after the full course vaccination
Neutralizing antibody assay will be performed using the micro-neutralization method
次要结局
- Safety index-Incidence of adverse reactions(From the beginning of the vaccination to 28 days after the full course vaccination)
- Safety index-Incidence of serious adverse events(From the beginning of the vaccination to 6 months after the full course vaccination)
- Immunogenicity index-Seroconversion rate of the neutralizing antibody(Day 14 after the full course vaccination)
- Immunogenicity index-Seropositive rate of the neutralizing antibody(Day 14 after the full course vaccination)