EUCTR2006-002680-18-BE进行中（未招募）不适用
A phase II, controlled, randomized, single blind study to evaluate the immunogenicity, safety and reactogenicity of the low dose influenza vaccine adjuvanted with AS03 compared to Fluarix™ (GlaxoSmithKline Biologicals) administered intramuscularly in elderly 60 years and older. - FLU-LD-003
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
- •A male or female age 60 years or older at the time of the vaccination.
- •Written informed consent obtained from the subject.
- •Free of obvious health problems as established by medical history and clinical examination before entering into the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
- •Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screenin tests.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent. 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).
- •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.
- •Administration of other licensed vaccines within 30 days prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol during the study period.
- •History of hypersensivity to a previous dose of influenza vaccine.
- •Previous vaccination against influenza within the 12 months prior to enrollment.
- •History of confirmed influenza infection within the last 12 months.
- •History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) including egg, chicken protein, gelatine, formaldehyde, gentamicin sulphate, thimerosal or sodium deoxycholate and adjuvant AS03 .
- •Acute disease at the time of enrolment.
- •History of administration of an experimental/licensed vaccine containing squalene and/or tocopherol (Vitamin E) within the last 12 Months.
研究者
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