EUCTR2008-000939-17-GB进行中（未招募）不适用
A Phase II, Open-Label, Uncontrolled, Single Center Study to Evaluate Safety and Immunogenicity of FLUVIRIN® [Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur], Formulation 2008-2009, when Administered to Non-Elderly Adult and Elderly Subjects - FLUVIRIN® 2008-2009 seasonal trial
ovartis Vaccines and Diagnostics Limited0 个研究点开始时间: 2008年4月4日最近更新:
适应症
相关药物
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
- •Subjects eligible for enrollment into this study are male and female adult volunteers who are:
- •1. >18 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry;
- •2. available for all the visits scheduled in the study and able to comply with all study requirements
- •3. in general good health as determined by:
- •a) medical history
- •b) physical examination
- •c) clinical judgment of the investigator
- •Written informed consent must be obtained from all the subjects before enrollment in the study after the nature of the study has been explained.
- •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
- •Subjects are not to be enrolled into the study if at least one of the following criteria is fulfilled:
- •1. Any serious (in the judgment of the investigator) disease 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. 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, neomycin, polymixin)
- •3. 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:
- •a. Receipt 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
- •b. Receipt of immunostimulants,
- •c. Receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months and for the full length of the study,
- •d. Suspected or known HIV infection or HIV-related disease.
- •4. Known or suspected history of drug or alcohol abuse.
- •5. The subject has 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. Women who are pregnant or woman of child-bearing potential unwilling to practice acceptable contraception for the duration of the study (21 days).
- •7. Influenza vaccination or laboratory confirmed influenza within the last 6 months and more than one influenza vaccination within the past 12 months
- •8. Within the past 4 weeks, the subject has received:
- •- another vaccine
- •- any investigational agent
- •9.Any acute or chronic infection requiring systemic antibiotic treatment or antiviral therapy within the last 7 days.
- •10. The subject has experienced an acute exacerbation of a COPD within the past 14 days
- •11. The subject has experienced fever (i.e. axillary temperature =38.0°C) within the last 3 days
- •12. Severely obese with Body Mass Index (BMI) > 35 kg/m2
- •13. Any condition, which, in the opinion of the investigator, might prevent the subject from participation or interfere with the evaluation of the study objectives
- •Site personnel involved in evaluation of safety and their immediate relatives are excluded from participation.
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