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 Over 3 Years.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,380
- 试验地点
- 2
- 主要终点
- The lower limit of 95% confidence intervals (95%CI) of the ratio of geometric mean titer of hemagglutination inhibition (HI) antibody titer (experimental group/control group)≥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 subjects aged over 3 years
详细描述
This study is a phase I& III clinical trial. Phase I is open-labelled, and phase III is randomized, double-blind, active-controlled. The purpose of this study is to evaluate the safety and immunogenicity of the quadrivalent influenza vaccine (QIV) (experimental vaccine) manufactured by Sinovac Biotech Co., Ltd in subjects aged over 3 years. In phase I, 60 volunteers received single dose QIV (15µg/0.5ml). In phase III, 2320 volunteers were assigned to receive single dose QIV (15µg/0.5ml) or two commercial trivalent influenza vaccines (TIVs) (15µg/0.5ml) in a ratio of 2:1:1. The commercial TIVs were also 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
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers aged ≥3 years;
- •Proven legal identity;
- •Participants or (and) guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrolment;
排除标准
- •Prior vaccination with influenza vaccine of the current year;
- •History of influenza within 6 months prior to study entry;
- •Axillary temperature > 37.0 °C;
- •History of allergy to any vaccine, or any ingredient of the experimental vaccine, especially eggs, egg albumin, etc.;
- •Serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc.;
- •Severe/uncontrollable nervous system disease (epilepsy, seizures or convulsions) or mental illness;
- •Autoimmune disease or immunodeficiency/immunosuppressive, or any immunosuppressant receipt within 6 months prior to the study entry;
- •History of asthma, thyroidectomy, angioedema, diabetes or malignancy;
- •No spleen, or functional no spleen, or splenectomy.
研究组 & 干预措施
Experimental group-phase III
Quadrivalent influenza vaccine
干预措施: Quadrivalent influenza vaccine (Biological)
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)
结局指标
主要结局
The lower limit of 95% confidence intervals (95%CI) of the ratio of geometric mean titer of hemagglutination inhibition (HI) antibody titer (experimental group/control group)≥2/3.
时间窗: 28 days after the injection
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 difference of HI antibody seroconversion rate (experimental group-control group)≥-10%
时间窗: 28 days after the injection
Immunogenicity index, Another standard to evaluate the experimental vaccine is non-inferior to the control vaccines
次要结局
- The lower limit of 95%CI of the ratio of GMT(experimental group/control group)>1.5 .(28 days after the injection)
- The lower limit of 95% CI of the difference of HI antibody seroconversion rate (experimental group-control group)>10%(28 days after the injection)
- The 95% CI lower limit of seroconversion rate of HI antibodies in the subjects aged 3-59 years≥40%(28 days after the injection)
- The 95% CI lower limit of seroconversion rate of HI antibodies in the subjects aged over 60 years≥30%(28 days after the injection)
- The seroprotective rate (HI antibody titer≥1:40) in the subjects aged 3-59 years ≥70%(28 days after the injection)
- The seroprotective rate (HI antibody titer≥1:40) in the subjects aged over 60 years ≥60%(28 days after the injection)
- The geometric mean increase (GMI) in the subjects aged 3-59 years >2.5(28 days after the injection)
- The geometric mean increase (GMI) in the subjects aged over 60 years >2.0(28 days after the injection)
- 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 the injection)
- 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 the injection)
- The incidence of the solicited local and general adverse reactions on day 0-7(0-7 days after the injection)
- The incidence of the unsolicited adverse events on day 0-28(0-28 days after the injection)
- The incidence of the serious adverse events within 6 months after the injection(Within 6 months after the injection)