NCT01306305已完成4 期
Open, Non-randomized Trial to Assess the Immunogenicity and Safety of the 2010/2011-season Influenza Vaccine in Elderly and Young Subjects According to European Medicines Agency (EMEA) Regulations
Crucell Holland BV2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2010年6月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Seroconversion
研究概览
简要总结
A study to assess whether the Northern Hemisphere 2010/2011 season influenza vaccine Inflexal V fulfills the EMEA 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
- Treatment
- 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 to ≤60 years or >60 years on Day 1
- •Written informed consent
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, incl. oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed)
- •Known immunodeficiency (incl. leukemia, cancer, HIV seropositivity)
- •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 or spouse of the investigator
- •Suspected non-compliance
结局指标
主要结局
Seroconversion
时间窗: Day 22 ± 2 days
Seroconversion rate was defined as the number of subjects with ≥4-fold increase in haemagglutination inhibition (HI) antibody titer and with a titer of ≥1:40
Seroprotection
时间窗: Day 22 ± 2 days
Seroprotection rate, defined as the number of subjects with HI antibody titer ≥1:40
Fold Increase in Geometric Mean Titer (GMT)
时间窗: Day 22/Day 1
GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value
次要结局
- Safety: Numbers of Subjects Reporting Solicited Local Adverse Events(Days 1 to 4 inclusive, and Days 8, 15 and 22)
- Numbers of Subjects Reporting Solicited Systemic Adverse Events(Days 1 to 4 inclusive, and Days 8, 15 and 22)
研究者
研究点 (2)
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