EUCTR2011-006271-18-DE进行中（未招募）不适用
A Phase 3 Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Influenza Vaccine (Fluvirin®), Flirmulation 2012/2013, when Administered to Adult and Elderly Subjects. - Fluvirin® 2012-2013 Seasonal Trial
ovartis Vaccines and Diagnostics S.r.l.0 个研究点目标入组 126 人开始时间: 2012年4月24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.Male and female 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 study.
- •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; i.e., GOLD Stage III and IV)
- •- 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. to eggs or eggs product as well as ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate).
- •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 study;
- •- 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.Individuals who are not able to comprehend and to follow all required study procedures for the whole period of the study.
- •8.Individuals with history or any illness that, in the opinion of the investigator, pose additional risk to the subjects due to participation in the study.
- •9.Individuals who within the past 6 months have:
- •- had any laboratory confirmed seasonal or pandemic influenza disease;
- •- received any seasonal or pandemic influenza vaccine.
- •10.Individuals who received any other vaccine within 4 weeks prior to enrollment in this study or who are planning to receive any vaccine during the study.
- •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 s
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