EUCTR2006-003769-15-BE进行中（未招募）不适用
A phase II, controlled, randomized, single centre, single blind study to evaluate the immunogenicity, safety and reactogenicity of the low dose influenza vaccine with various doses of AS03 adjuvant compared to Fluarix™ (GlaxoSmithKline Biologicals) administered intramuscularly in subjects aged 18-59 years old. - FLU-LD-004
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 aged 18-59 years old at the time of the vaccination.
- •Free of obvious health problems 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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Use of any investigational or non-registered product 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 screening 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.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •Administration of immunoglobulins and/or any blood products within three months preceding the 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 in 2006.
- •History of confirmed influenza infection within the last 12 months.
- •History of allergy or reactions likely to be exacerbated by any component of the vaccines
- •Pregnancy.
- •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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