EUCTR2006-001918-33-DE进行中（未招募）不适用
A Phase III study for evaluation of immunogenicity and reactogenicity of Fluarix™ (Influspit SSW®) 2006/2007 in people aged 18 years or above - Flu-063
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- •A male or female aged 18 years or above at the time of the vaccination.
- •Written informed consent obtained from the subject.
- •Healthy subjects or with well-stabilized chronic diseases as established by medical history and clinical examination before entering into the study.
- •If the subject is female, she must be of non-childbearing potential
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- •Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
- •Administration of an influenza vaccine within 6 months preceding the study start
- •Administration of an influenza vaccine other than the study vaccine during the entire study
- •Confirmed influenza infection within 6 months preceding the study start
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Acute disease at the time of enrolment.
- •Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- •Not stabilized or clinically serious chronic underlying disease (such as cancer, chronic obstructive pulmonary disease under oxygen therapy, insuline-dependent diabetes Mellitus)
- •Lactating female.
- •History of chronic alcohol consumption and/or drug abuse.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
研究者
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