NCT00866580撤回3 期
Immunogenicity and Safety of GSK Biologicals' (Pre-) Pandemic Influenza Candidate Vaccine GSK 1562902A.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Serum HI antibody titres
研究概览
简要总结
This observer-blind study is designed to evaluate the immune response and safety of pandemic influenza vaccine in the elderly population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 61 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects aged 61 years or above at the time of the first study visit (Day -30).
- •Female subjects of non-childbearing potential.
- •Healthy subjects or subjects with well controlled chronic medical condition (at the discretion of the investigator).
- •Written informed consent obtained from the subject.
- •Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device.
- •Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
排除标准
- •Previous administration of the licensed MF59-containing vaccines, e.g. Fluad™ or Addigrip™ or virosome-based influenza vaccines such as Inflexal V™, InfectoVac Flu™ or Invivac™ .
- •Previous administration of the 2009 Southern Hemisphere or 2008-2009 Northern Hemisphere influenza vaccine.
- •Previous administration of a pandemic influenza vaccine.
- •Administration of licensed vaccines within 4 weeks prior to enrolment in this study.
- •Planned administration of a vaccine not foreseen by the study protocol up to 30 days after the second vaccination with H5N1 vaccine.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first study vaccination.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •History of chronic alcohol consumption and/or drug abuse.
- •History of hypersensitivity to vaccines.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- •Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- •Acute disease and/or fever at the time of enrolment.
- •Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination..
- •Administration of immunoglobulins and/or any blood products within the three months preceding the first study vaccination or during the study.
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days prior to the first vaccination, or planned use during the study period.
- •Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
结局指标
主要结局
Serum HI antibody titres
时间窗: Day -30, Day 42
次要结局
- Serum HI antibody titres(Day -30, Day 42, Month 6, Month 12)
- Serum neutralising antibody titres(Day -30, Day 42, Month 6, Month 12)
- Occurrence, intensity, and relationship to vaccination of solicited local and general signs and symptoms(Day 0 - Day 6 after each vaccination)
- Occurrence, intensity and relationship to vaccination of unsolicited adverse events(Day 0 - Day 29 after vaccination, Day 0 - Day 20 after investigational vaccination)
- Occurrence and relationship to vaccination of serious adverse events(Day 0 - Month 6)
- Occurrence of adverse events of specific interest(Day 0 - Month 12)
研究者
研究点 (2)
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