A Double-blind, Randomized Clinical Trial to Evaluate the Lot-to-lot Consistency, Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine (CoronaVac）Between Different Workshops for Prevention of COVID-19 in Healthy Children Aged 3-17 Years
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,520
- 试验地点
- 1
- 主要终点
- Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2
研究概览
简要总结
This study is a double-blind, randomized phase Ⅳ clinical trial of the inactivated SARS-CoV-2 vaccine (CoronaVac)manufactured by Sinovac Research & Development Co., Ltd. The purpose of this study is to evaluate the lot-to-lot consistency ,immunogenicity and safety of COVID-19 vaccine between the commercialized scale in workshop 2 and 3 and the commercialized scale in workshop 1 in healthy children aged 3-17 years.
详细描述
This study is a double-blind, randomized phase Ⅳ clinical trial in healthy children aged 3-17 years to evaluate the lot-to-lot consistency, immunogenicity and safety of the commercial-scale CoronaVac in healthy children aged 3-17 years .The experimental vaccine was manufactured by Sinovac Research & Development Co.,Ltd. A total of 2520 healthy subjects aged 3 to 17 years old will be enrolled.The subjects will be randomly divided into 7 groups of 360 participants per group with an equal probability to received 7 batches of commercial-scale vaccine.All subjects received two doses of vaccine on day 0 and day 28.
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
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children aged 3-17;
- •The subjects and/or guardians can understand and voluntarily sign the informed consent form (For subjects aged 8-17 years, both subjects and guardians need to sign the informed consent form)
- •Proven legal identity.
排除标准
- •History of SARS-CoV-2 infection;
- •History of receiving COVID-19 vaccine;
- •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,absence of spleen, functional absence of spleen, absence of spleen due to any condition or splenectomy;
- •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;
- •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;
- •Onset of various acute or chronic diseases within 7 days prior to the study;
- •Axillary temperature >37.0°C;
- •The subjects participated in other clinical trials during the follow-up period, or will be planned within 3 months;
- •Already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to get pregnant within 2 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
Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2
时间窗: 28 days after the full immunization
Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2 28 days after the full immunization of each lot of COVID-19 vaccine
次要结局
- Incidence of adverse reactions 0-28 days after vaccination(0-28 days after vaccination)
- Geometric mean increase (GMI) of the neutralizing antibody to live SARS-CoV-2(28 days after the full immunization)
- Seroconversion rate of the neutralizing antibody to live SARS-CoV-2(28 days after the full immunization)
- Seropositivity rate of the neutralizing antibody to live SARS-CoV-2(28 days after the full immunization)
- Incidence of adverse reactions 0-7 days after vaccination(0-7 days after vaccination)