EUCTR2007-001828-12-DE进行中（未招募）不适用
A Phase III, open, non-randomized, multi-centric, single dose study to assess immunogenicity and safety of Fluarix™ (Influsplit SSW®) 2007/2008 injected intramuscularly in young adults (18 to 60 years) and in elderly (over 60 years). - Fluarix-064
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •All subjects must satisfy the following criteria at study entry:
- •Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) 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-controlled 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, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for the duration of the study
- •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. (For corticosteroids, this will mean prednisone, or equivalent, ? 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
- •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 1 year preceding the study start.
- •Administration of an influenza vaccine other than the study vaccine during the entire study
- •Clinically or virologically confirmed influenza infection within 1 year 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 disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature <37.5°C / Axillary temperature <37.5°C)
- •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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