EUCTR2007-001404-20-DE进行中（未招募）不适用
A Phase III, multicenter, uncontrolled, open-label study to evaluate safety and immunogenicity of a single intramuscular dose of a trivalent subunit influenza vaccine produced in mammalian cell culture (Optaflu), using the strain composition 2007/2008, when administered to adult and elderly subjects
ovartis Vaccines and Diagnostics GmbH & Co. KG0 个研究点开始时间: 2007年4月23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. = 18 years of age, mentally competent, willing and able to give 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 good health as determined by:
- •- medical history
- •- physical examination
- •- clinical judgment of the investigator
- •4. 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
- •1. Any serious chronic or acute disease such as:
- •a. Cancer (leukemia, lymphomas, neoplasm), except for benign or localized skin cancer and non-metastatic prostate cancer not presently treated with chemotherapy
- •b. Congestive heart failure
- •c. Advanced arteriosclerotic disease
- •d. Chronic obstructive pulmonary disease (COPD) requiring oxygen therapy and/or acute exacerbation of a COPD within the last 14 days.
- •e. Autoimmune disease (including rheumatoid arthritis), if under immunosuppressive therapy (see below)
- •f. Insulin dependent diabetes mellitus
- •g. Acute or progressive hepatic disease
- •h. Acute or progressive renal disease
- •i. Severe neurological or psychiatric disorder
- •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 or polymyxin).
- •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 (chronic therapy with immunosuppressive drugs, any parenteral or oral corticosteroid (substitution dose in case of absence of suprarenal function allowed) or cancer chemotherapy/radiotherapy) within the last 2 months 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. Bleeding diathesis or receive anticoagulants of the coumarin type.
- •6. Women who are pregnant or woman of childbearing 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. Immunization with any other vaccine and/or any investigational vaccine four weeks prior to study start
- •9. Any significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days.
- •10. Fever (i.e. body temperature = 38.0°C) within the past 3 days prior to study entry.
- •11. Simultaneous participation in another clinical study.
- •12. Any condition, which, in the opinion of the investigator, might prevent the subject from participation or interfere with the evaluation of the study objectives.
研究者
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