EUCTR2009-012188-32-SE进行中（未招募）不适用
A phase III, observer-blind, multicountry, multicentre study to evaluate the safety, reactogenicity and immunogenicity of GlaxoSmithKline Biologicals’ GSK2186877A influenza vaccine administered to adults aged 66 years and older compared to Fluarix™ administered to adults aged 19-43 years and 66 years and older, who previously participated in the 111737 study. - FLU NG-039 EXT: FLU-AS25-025 Y2
适应症
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
- 526
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 (e.g., completion of the diary cards, return for follow-up visits, reporting by phone) should be enrolled in the study. Specific attention should be given to the compliance potential of subjects with suspected drug or alcohol abuse.
- •A male or female aged 19-43 years or 66 years or older at the time of the vaccination and who participated in the 111737 study and completed the 6-month follow-up.
- •Written informed consent obtained from the subject.
- •Free of an acute aggravation of the health status as established by clinical evaluation (medical history and physical examination) before entering into the study.
- •Female subjects of non-childbearing potential may be enrolled in the study.
- •? Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
- •Female subjects of childbearing potential may be enrolled in the study if the subject:
- •? has practiced adequate contraception for 30 days prior to vaccination, and
- •? has a negative pregnancy test on the day of vaccination, and
- •? has agreed to continue adequate contraception for 2 months after the vaccination.
- •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 prior to vaccination, or planned use during the study period.
- •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 an influenza vaccine other than the study vaccines or of a vaccine not foreseen in the study protocol during the entire study period.
- •Vaccination against influenza since January 2009 with a seasonal influenza vaccine.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine. (For corticosteroids, this will mean prednisone, or equivalent, >/=20 mg/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).
- •Acute clinically significant pulmonary, cardiovascular, hepatic, renal, neurological and psychiatric disorders, as determined by clinical evaluation (medical history and physical examination) or pre-existing laboratory screening tests.
- •Acute disease and/or fever at the time of enrolment.
- •? Fever is defined as temperature =37.5°C on oral setting.
- •? Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
- •Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned administration during the study.
- •Any medical conditions in which IM injections are contraindicated
- •Pregnant or lactating female.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions.
研究者
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