EUCTR2010-019040-39-DE进行中（未招募）不适用
A Phase III, multicenter, uncontrolled, open label study to evaluate safety and immunogenicity of FLUVIRIN® [Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur], Formulation 2010/2011, when administered to adult and elderly subjects. - FLUVIRIN® 2010-2011 seasonal trial
ovartis Vaccines and Diagnostics GmbH0 个研究点目标入组 126 人开始时间: 2010年4月1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
- •Subjects eligible for enrollment into this study are male and female adults who are
- •1. 18 years of age and 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 medical history, physical examination and clinical judgment of the investigator.
- •Written informed consent must be obtained for all the subjects before enrollment into 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. 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 study;
- •2. Individuals with 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;
- •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. to ovalbumin, chicken protein, chicken feathers, influenza viral
- •protein, polymyxin, neomycin)
- •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:
- •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 derivates within the past 3 months and for the full length of the
- •d. 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
- •7. Female who are pregnant or nursing (breastfeeding) mothers or females of
- •childbearing age do not plan to use acceptable birth control measures, for the
- •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 that within the past 12 months have received more than one injection
- •of influenza vaccine;
- •10. Individuals that within the past 6 months have:
- •a. had laboratory confirmed seasonal or pandemic influenza disease;
- •b. received seasonal or pandemic influenza vaccine;
- •11. Individuals with any acute or chronic infections requiring systemic antibiotic
- •treatment or antiviral therapy within the last 7 days
- •12. Individuals that have experienced fever (i.e., axillary temperature = 38°C) within
- •the last 3 days of intended study vaccination
- •13. Individuals participating in any clinical trial with another investigational product
- •4 weeks prior to first study visit or intent to participate in another clinical study at
- •any time during the conduct of this study.
- 另有 2 项未显示
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