EUCTR2006-003236-30-BE进行中（未招募）不适用
A phase II, open, controlled study to evaluate the reactogenicity and the immunogenicity of GlaxoSmithKline Biologicals AS25 adjuvanted influenza vaccine (FluAS25) in elderly adults previously vaccinated in FluAS25-003 clinical trial with the same candidate vaccine. Fluarix™ administered in young and elderly adults will be used as reference. - FluAS25-004
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
- •- Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
- •- Written informed consent obtained from the subject.
- •- Healthy subjects 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. either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (i.e. intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant® or DepoProvera®) for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
- •In the FluAS25 group, all subjects must satisfy the following criteria at study entry:
- •- A male or female aged 66 years or above at the time of the revaccination, who previously received FluAS25 during the FluAS25-003 clinical trial.
- •In the Fluarix Yng and Fluarix Eld groups, all subjects must satisfy the following criteria at study entry:
- •- A male or female aged between, and including, 19 and 41 years of age or over 65 years at the time of revaccination; who previously received Fluarix during the FluAS25-003 clinical trial.
- •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 administration of the study vaccine, 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 administration of the study vaccine. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
- •- History of confirmed influenza infection since the date of previous vaccination.
- •- 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 allergic disease or reactions likely to be exacerbated by any component of the vaccine including egg, chicken protein, formaldehyde, thiomersal, gentamicin sulfate or sodium deoxycholate.
- •- Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- •- Acute disease at the time of enrolment.
- •- Administration of immunoglobulins and/or any blood products within the three months preceding vaccination or planned administration during the study period.
研究者
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