A Randomized, Double-blind Clinical Trial to Evaluate Lot-to-lot Consistency , Immunogenicity and Safety of Quadrivalent Influenza Vaccine (Split Virion), Inactivated in Health Populations Aged 9~59 Years Old
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,260
- 试验地点
- 1
- 主要终点
- Immunogenicity index of GMT
研究概览
简要总结
This study is a randomized, double-blind phase Ⅳ clinical trial of quadrivalent influenza vaccine (Split Virion), inactivated manufactured by Sinovac Biotech Co., Ltd.The purpose of this study is to evaluate the lot-to-lot consistency, immunogenicity and safety of quadrivalent influenza vaccine (Split Virion), inactivated in health subjects aged 9-59 years old.
详细描述
This study is a randomized, double-blind phase Ⅳ clinical trial in health subjects aged 9-59 years old to evaluate the lot-to-lot consistency,immunogenicity and safety of quadrivalent influenza vaccine (Split Virion), inactivated.The experimental vaccine was manufactured by Sinovac Biotech Co., Ltd.A total of 1260 subjects,including 360 subjects aged 9-17 years and 900 subjects aged 18-59 years will be enrolled.The subjects in each age group will be randomly divided into three groups in a ratio of 1:1:1 to receive one dose of three lots of quadrivalent influenza vaccine (Split Virion), inactivated produced on a commercial scale,respectively.
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
- Single (Participant)
入排标准
- 年龄范围
- 9 Years 至 59 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects aged 9-59 years;
- •The subjects and/or guardians can understand and voluntarily sign the informed consent form (For subjects aged 9-17 years, both subjects and guardians need to sign the informed consent form).
- •Proven legal identity.
排除标准
- •Received seasonal influenza vaccine for 2022-2023 influenza season, or had an influenza vaccine schedule during the study;
- •Suffering from seasonal influenza in the past 6 moths;
- •Women of childbearing age (menarche to premenopause) are pregnant(including positive urine pregnancy test), breastfeeding or planning pregnancy within 1 month;
- •Patients with fever on the day of vaccination,underarm body temperature>37.2 ℃;
- •History of asthma, allergy to vaccines or vaccine components, and serious adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema;
- •Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
- •Severe chronic diseases,such as severe cardiovascular diseases, hypertension(Systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg) 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;
- •Autoimmune disease or immune deficiency/immunosuppression;
- •Thyroid disease or history of thyroidectomy,absence of spleen, functional functional asplenia,and absence of spleen or splenectomy as a result of any condition;
- •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;
- •A long history of alcohol or drug abuse;
- •Onset of various acute or chronic diseases within 7 days prior to the study;
- •Receipt of blood products within in the past 3 months;
- •Receipt of other investigational drugs within 30 days prior to receiving the investigational vaccine;
- •Receipt of attenuated live vaccines or COVID-19 vaccines in the past 14 days,receipt of inactivated or subunit vaccines in the past 7 days;
- •The subjects participated in other clinical trials during the follow-up period or will be planned to participate other clinical trials during the follow-up 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 of GMT
时间窗: 28 days after vaccination
GMT of HI antibodies of each influenza strain at 28 days after vaccination.
次要结局
- Immunogenicity index of protection rate(28 days after vaccination)
- Safety index of the incidence of adverse reactions(From 0 to 28 days after vaccination.)
- Safety index of the incidence of serious adverse events(From 0 to 28 days after vaccination)
- Immunogenicity index of GMI(28 days after vaccination)
- Immunogenicity index of seroconversion rate(28 days after vaccination)
- Safety index -The incidence of adverse reactions(From 0 to 7 days after vaccination.)
- Safety index of incidence of adverse events(From 0 to 28 days after vaccination)