EUCTR2008-001047-19-IT进行中（未招募）不适用
A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of FLUad Surface Antigen, Inactivated, Adjuvanted with MF59C.1 Influenza Vaccine, Formulation 2008-2009, when Administered to Elderly Subjects - ND
OVARTIS VACCINES AND DIAGNOSTICS S.R.L.0 个研究点开始时间: 2009年5月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •1. 65 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry; 2. able to comply with all the study requirements; 3. in general good health as determined by: ▫ medical history; ▫ physical examination; ▫ clinical judgment of the investigator;
- •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
- •1. They have any serious chronic or acute disease (in the judgment of the investigator) including but not limited to: a. Cancer, except for localized skin cancer; b. Advanced congestive heart failure; c. Chronic obstructive pulmonary disease (COPD); d. Autoimmune disease (including rheumatoid arthritis); e. Acute or progressive hepatic disease; f. Acute or progressive renal disease; g. Severe neurological or psychiatric disorder; h. Severe asthma. 2. They have history of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g. to ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate); 3. They have a known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting, for example, from: - recipt of immunosuppressive therapy (any parenteral or oral corticosteroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study; - recipt of immunostimulants; - recipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study; - suspected or known HIV infection or HIV-related disease; 4. They have a known or suspected history of drug or alcohol abuse; 5. They have a bleeding diathesis or condition associated with prolonged bleeding time that in the investigator?s opinion would interfere with the safety of the subject; 6. Within the past 12 months, they have: - received more than one injection of influenza vaccine; 7. Within the past 6 months, they have: - had laboratory confirmed influenza disease; - received influenza vaccine; 8. Within the past 4 weeks they have received: - another vaccine; - any investigational agent; 9. They have any acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days; 10. They have experienced an acute exacerbation of a COPD within the past 14 days; 11. They have experienced fever (i.e., axillary temperature ≥ 38C) within the last 3 days; 12. They are taking part in another clinical study; 13. They have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives; 14. They have severely obese with Body Mass Index (BMI) > 35
研究者
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