EUCTR2011-006277-25-DE进行中（未招募）不适用
A Phase III Open Label, Uncontrolled, Multi Center Study to Evaluate Safety andImmunogenicity of a Surface, Antigen, Inactivated, Influenza Vaccine Produced inMammalian Cell Culture (Optaflu®), Formulation 2012/2013, when Administeredto adult and elderly subjects. - Optaflu
ovartis Vaccines and Diagnostics GmbH0 个研究点目标入组 126 人开始时间: 2012年3月12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
- 入组人数
- 126
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. Males and females volunteers of 18 years of age or older, mentally competent, willing
- •and able to give written informed consent prior to study entry;
- •2. Individuals able to comply with all the study requirements;
- •3. Individuals in good health as determined by the outcome of medical history, physical
- •examination and 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 63
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 63
排除标准
- •1. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the
- •opinion of the investigator, may interfere with the subject's ability to participate in the
- •2. Individuals with any serious chronic or acute disease (in the judgment of the
- •investigator), including but not limited to:
- •Medically significant Cancer (except for benign or localized skin cancer, cancer in
- •remission for =10 years or localized prostate cancer that has been clinically stable for
- •more than 2 years without treatment)
- •Medically significant advanced congestive heart failure (ie. NYHA class III and IV)
- •Chronic obstructive pulmonary disease (COPD);
- •Autoimmune disease (including rheumatoid arthritis, except for Hashimoto's
- •thyroiditis that has been clinically stable for = 5 years)
- •Diabetes mellitus type I;
- •Poorly controlled diabetes mellitus type II;
- •Advanced arteriosclerotic disease;
- •History of underlying medical condition such as major congenital abnormalities
- •requiring surgery, chronic treatment, or associated with developmental delay (e.g.,Down’s syndrome);
- •Acute or progressive hepatic disease;
- •Acute or progressive renal disease;
- •Severe neurological (es. Guillain–Barré syndrome) or psychiatric disorder;
- •Severe asthma
- •3. Individuals with 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. influenza viral protein, and exipients);
- •4. Individuals with 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:
- •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
- •receipt of immunostimulants;
- •receipt 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;
- •5. Individuals with known or suspected history of drug or alcohol abuse
- •6. Individuals with a bleeding diathesis or conditions associated with prolonged bleeding
- •time that in the investigator’s opinion would interfere with the safety of the subject
- •7. Female who are pregnant or nursing (breastfeeding) mothers or females of
- •childbearing potential do not plan to use acceptable birth control measures, for the
- •whole duration of the study. Adequate contraception is defined as hormonal (e.g.,
- •oral, injection, transdermal patch, implant, cervical ring), barrier (e.g., condom with
- •spermicide or diaphragm with spermicide), intrauterine device (IUD), or
- •monogamous relationship with vasectomized partner who has been vasectomized for
- •6 months or more prior to the subject’s study entry
- •8. Individuals who are not able to comprehend and to follow all required study
- •procedures for the whole period of the study
- •9. Individuals with history or any illness that, in the opinion of the investigator, might
- •interfere with the results of the study or pose additional risk to the subjects due to
- •participation in the study.
- •10. Individuals Within the past 6 months, they have:
- •had any seasonal or pandemic laboratory confirmed influenza disease;
- •received any seasonal or pandemic influenza vaccine;
- 另有 1 项未显示
研究者
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