Open, Non-randomized Trial to Assess the Immunogenicity and Safety of the 2013/2014-season Virosomal Subunit Influenza Vaccine in Elderly and Young Subjects According to EMA Regulations
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Percentage of subjects with seroconversion, seroprotection, and fold increase in geometric mean titer (GMT)
研究概览
简要总结
The study is to assess whether the influenza vaccine Inflexal V for season 2013/2014 fulfills the EMA requirements for re-registration of influenza vaccines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy female and male adults aged ≥18 on Day 1
- •Written informed consent
- •Female subjects of childbearing potential using and willing to continue using an acceptable method of contraception unless surgically sterilized/hysterectomized or post-menopausal for more than 2 years
排除标准
- •Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease
- •Acute febrile illness (≥38.0 °C)
- •Prior vaccination with an influenza vaccine in the past 330 days
- •Known hypersensitivity to any vaccine component
- •Previous history of a serious adverse reaction to influenza vaccine
- •History of egg protein allergy or severe atopy
- •Known blood coagulation disorder
- •Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of the study vaccine, including oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed)
- •Known immunodeficiency (incl. leukemia, HIV seropositivity), cancer
- •Investigational medicinal product received in the past 3 months (90 days)
- •Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days)
- •Pregnancy or lactation
- •Participation in another clinical trial
- •Employee at the investigational site, or relative of the investigator
- •Subjects who in the view of the investigator will not comply with study procedures and/or visit requirements as per protocol
结局指标
主要结局
Percentage of subjects with seroconversion, seroprotection, and fold increase in geometric mean titer (GMT)
时间窗: Day 22 +/- 2 days
Immunogenicity variables are analyzed according to the EMA re-licensing criteria; at least one of the criteria has to be fulfilled for each vaccine strain: * Seroconversion rate at Day 22 has to be \>40% of subjects aged ≥18 to ≤60 years and \>30% of subjects aged \>60 years, or * Seroprotection rate at Day 22 has to be \>70% of subjects aged ≥18 to ≤60 years and \>60% of subjects aged \>60 years, or * GMT-fold increase at Day 22 compared to baseline: a \>2.5-fold increase has to be reached in subjects aged ≥18 to ≤60 years and a \>2.0-fold increase has to be reached in subjects aged \>60 years
次要结局
- Incidence of solicited local adverse events(Days 1 to 4 inclusive)
- Incidence of solicited systemic adverse events(Days 1 to 4 inclusive)
- Incidence of unsolicited adverse events(Days 1 to 22 inclusive)