EUCTR2007-002368-83-DE进行中（未招募）不适用
A phase III, observer-blind, multicountry, multicenter, study to evaluate the safety, reactogenicity and immunogenicity, of GlaxoSmithKline Biologicals AS25 adjuvanted influenza vaccine administered intramuscularly in adults aged 65 years and older previously vaccinated in the FluAS25-005 clinical trial with the same candidate vaccine. Fluarix™ administered in adults aged 65 years and older will be used as reference. - FluAS25-010 EXT:005 Y1
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
- 1,967
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 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.
- •Written informed consent obtained from the subject.
- •Free of an acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed 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 2 months after completion of the vaccination series.
- •Male or female subjects who participated in the FluAS25-005 study and were
- •enrolled in the = 65 years age group (received FluAS25 or Fluarix) or in the 18-
- •40 years age group (received Fluarix).
- •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
- •Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination
- •Planned administration of an influenza vaccine other than the study vaccines
- •during the entire study period
- •Any vaccination against influenza since January 2007 (with the 2006/2007 or
- •the 2007/2008 influenza vaccine)
- •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.)
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •History of hypersensivity to a previous dose of influenza vaccine
- •History of allergy or reactions likely to be exacerbated by any component of the
- •vaccine(s) including egg, chicken protein, formaldehyde, gentamicin sulphate,
- •thimerosal or sodium deoxycholate and adjuvant AS25 (containing squalene, a-
- •tocopherol, Tween 80 and MPL)
- •Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal
- •functional abnormality, as determined by physical examination or pre-existing
- •laboratory screening tests
- •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 (99.5°F) / Axillary temperature <37.5°C (99.5°F)
- •Administration of immunoglobulins and/or any blood products within the three
- •months preceding the first dose of study vaccine or planned administration during the study period
- •Use of any investigational or non-registered product (drug or vaccine) other than
- •the study vaccine(s) within 30 days prior to vaccination, or planned use during the study period
- •Any medical conditions in which IM injections are contraindicated
- •Pregnant or lactating female, or planning to become pregnant or to discontinue
- •contraceptive precautions.
研究者
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