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.
研究组 & 干预措施
Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 2
360 Participants aged 3-17 years(including 52 children aged 3-5 years,154 children aged 6-11 years and 154 adolescents aged 12-17 years) will receive Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 2 according to 0,28-day immunization schedule.
干预措施: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 2 (Biological)
Inactivated SARS-CoV-2 vaccine Lot 2 of the workshop 2
360 Participants aged 3-17 years(including 52 children aged 3-5 years,154 children aged 6-11 years and 154 adolescents aged 12-17 years) will receive Inactivated SARS-CoV-2 vaccine Lot 2 of the workshop 2 according to 0,28-day immunization schedule.
干预措施: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 2 of the workshop 2 (Biological)
Inactivated SARS-CoV-2 vaccine Lot 3 of the workshop 2
360 Participants aged 3-17 years(including 52 children aged 3-5 years,154 children aged 6-11 years and 154 adolescents aged 12-17 years) will receive Inactivated SARS-CoV-2 vaccine Lot 3 of the workshop 2 according to 0,28-day immunization schedule.
干预措施: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 3 of the workshop 2 (Biological)
Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 3
360 Participants aged 3-17 years(including 52 children aged 3-5 years,154 children aged 6-11 years and 154 adolescents aged 12-17 years) will receive Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 3 according to 0,28-day immunization schedule.
干预措施: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 3 (Biological)
Inactivated SARS-CoV-2 vaccine Lot 2 of the workshop 3
360 Participants aged 3-17 years(including 52 children aged 3-5 years,154 children aged 6-11 years and 154 adolescents aged 12-17 years) will receive Inactivated SARS-CoV-2 vaccine Lot 2 of the workshop 3 according to 0,28-day immunization schedule.
干预措施: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 2 of the workshop 3 (Biological)
Inactivated SARS-CoV-2 vaccine Lot 3 of the workshop 3
360 Participants aged 3-17 years(including 52 children aged 3-5 years,154 children aged 6-11 years and 154 adolescents aged 12-17 years) will receive Inactivated SARS-CoV-2 vaccine Lot 3 of the workshop 3 according to 0,28-day immunization schedule.
干预措施: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 3 of the workshop 3 (Biological)
Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 1
360 Participants aged 3-17 years(including 52 children aged 3-5 years,154 children aged 6-11 years and 154 adolescents aged 12-17 years) will receive Inactivated SARS-CoV-2 vaccine Lot 1 of the workshop 1 according to 0,28-day immunization schedule.
干预措施: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 1 (Biological)
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
- Seroconversion rate of the neutralizing antibody to live SARS-CoV-2(28 days after the full immunization)
- 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)
- 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)