Open Phase I and Randomized, Double-blind, Controlled Phase III Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine in Healthy Subjects Aged 6-35 Months
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,340
- 试验地点
- 2
- 主要终点
- The lower limit of 95% confidence intervals (95%CI) of geometric mean titer (GMT) ratio (experimental group/control group) of hemagglutination inhibition (HI) antibody titer≥2/3.
研究概览
简要总结
The purpose of this study is to evaluate the safety and immunogenicity of quadrivalent influenza vaccine in healthy children aged 6-35 months.
详细描述
The study includes open-labelled phase I and randomized, double-blind, controlled phase III clinical trial. In the phase I, 20 healthy Chinese children aged 6-35 months were administered with two doses of QIV (7.5μg/0.25ml). In the phase Ⅲ clinical trial, 2320 children were assigned to QIV group, TIV (B/Victoria) group and TIV (B/Yamagata) group in a 2:1:1 ratio. All vaccines were manufactured by Sinovac Biotech Co., Ltd.
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
- 6 Months 至 35 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteer between 6 - 35 months old; Term birth; Birth weight >2500g;
- •Proven legal identity;
- •Written consent of the guardian(s) of the volunteer;
排除标准
- •Received seasonal influenza vaccine in the current year;
- •Suffering from seasonal influenza in the past 6 moths;
- •Axillaty temperature > 37.0 °C;
- •History of allergy to any vaccine or vaccine ingredient;
- •History of serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc;
- •Autoimmune disease or immunodeficiency;
- •Congenital malformation, developmental disorders;
- •Severe malnutrition;
- •Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders;
- •History of epilepsy (except febrile seizures occurred < 2 years of age or pure epilepsy occurred within the past 3 years that does not need treatment)
- •Chronic diseases (e.g., viral hepatitis, tuberculosis, diabetes, blood diseases, or neurological disorders)
- •Acute disease or acute stage of chronic disease;
- •Receipt of any of the following products:
- •Any subunit vaccine or inactivated vaccine (e.g., pneumococcal vaccine) or treatment of allergy within 14 days prior to study entry;
- •Any live attenuated vaccine within 30 days prior to study entry;
- •Any other investigational medicine(s) or vaccine within 30 days prior to study entry;
- •Blood product within 3 months prior to study entry;
- •Any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) within 6 month prior to study entry;
- •Participate or will participate in other clinical trial(s) during this study;
- •Based on the judgment of investigator(s) or the Ethic Committee, there was any condition indicating that the subject should be excluded;
研究组 & 干预措施
Control group 1-phase Ⅲ
Trivalent influenza vaccine (contains B/Victoria strain)
干预措施: Trivalent influenza vaccine (contains B/Victoria strain) (Biological)
Control group 2-phase Ⅲ
Trivalent influenza vaccine (contains B/Yamagata strain)
干预措施: Trivalent influenza vaccine (contains B/Yamagata strain) (Biological)
Experimental group-phase Ⅰ
Quadrivalent influenza vaccine
干预措施: Quadrivalent influenza vaccine (Biological)
Experimental group-phase Ⅲ
Quadrivalent influenza vaccine
干预措施: Quadrivalent influenza vaccine (Biological)
结局指标
主要结局
The lower limit of 95% confidence intervals (95%CI) of geometric mean titer (GMT) ratio (experimental group/control group) of hemagglutination inhibition (HI) antibody titer≥2/3.
时间窗: 28 days after two doses immunization
Immunogenicity index, One of the standard to evaluate the experimental vaccine is non-inferior to the control vaccines.
The lower limit of 95% CI of the seroconversion rate difference (experimental group-control group)≥-10%.
时间窗: 28 days after two doses immunization
Immunogenicity index, Another standard to evaluate the experimental vaccine is non-inferior to the control vaccines.
次要结局
- The seroprotective rate (HI antibody titer≥1:40) of each HI antibody after two doses immunization≥70%.(28 days after two doses immunization)
- The lower limit of 95% CI of the difference of HI antibody seroconversion rate (experimental group-control group)≥-10%, in the subjects whose pre-immune HI antibody titer<1:40.(28 days after two doses immunization)
- The incidence of the unsolicited adverse events 0-28 days after each immunization(0-28 days after each dose immunization)
- The lower limit of 95%CI of the ratio of GMT (experimental group/control group) >1.5.(28 days after two doses immunization)
- The incidence of the serious adverse events within 7 months after the first immunization.(Within 7 months after the first dose immunization)
- The geometric mean increase (GMI) of each HI antibody after two doses immunization >2.5.(28 days after two doses immunization)
- The incidence of the solicited local and general adverse reactions 0-7 days after each immunization.(0-7 days)
- The lower limit of 95% CI of the difference of HI antibody seroconversion rate (experimental group-control group)>10%(28 days after two doses immunization)
- The lower limit of 95% CI of seroconversion rate for each HI antibody after two doses immunization≥40%.(28 days after two doses immunization)
- The lower limit of 95%CI of the ratio of GMT(experimental group/control group)≥2/3, in the subjects whose pre-immune HI antibody titer<1:40(28 days after two doses immunization)