EUCTR2005-000659-14-GB进行中（未招募）1 期
A Phase II, Open-Label, Uncontrolled, Single Center Study to Evaluate Safety and Immunogenicity of FLUVIRIN® Surface Antigen, Inactivated Influenza Vaccine, Formulation 2005-2006, when administered to Non-Elderly Adult and Elderly Subjects
Chiron Vaccines Limited0 个研究点目标入组 100 人开始时间: 2005年4月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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, and able to give the written
- •informed consent prior to study entry;
- •2.able to comply with all the study requirements;
- •3.in good health as determined by:
- •·medical history
- •·physical examination
- •·clinical judgment of the investigator
- •Informed consent must be obtained for all the subjects before enrollment in the study.
- •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
- •Individuals are not to be enrolled into the study if:
- •1.they have any serious disease such as:
- •·cancer (except for benign or localized skin cancer and non
- •metastatic prostate cancer not presently treated with
- •chemotherapy)
- •·autoimmune disease (including rheumatoid arthritis)
- •·advanced arteriosclerotic disease or complicated diabetes
- •·chronic obstructive pulmonary disease (COPD) that requires
- •oxygen therapy
- •·acute or progressive hepatic disease
- •·acute or progressive renal disease
- •·congestive heart failure
- •2.they are hypersensitive to eggs, chicken protein, chicken feathers,
- •influenza viral protein, thiomersal, neomycin or polymyxin or any other
- •component of the vaccine;
- •3.they have a history of neurological symptoms or signs, or anaphylactic
- •shock following administration of any vaccine;
- •4.they have a known or suspected (or have a high risk of developing)
- •impairment/ alteration of immune function (excluding that normally
- •associated with advanced age) resulting in:
- •·receipt of immunosuppressive therapy (any parenteral or oral
- •cortical steroid or cancer chemotherapy/radiotherapy)
- •·receipt of immunostimulants
- •·receipt of parenteral immunoglobulin preparation, blood
- •products and/or plasma derivates within the past 3 months
- •·suspected or known HIV infection or HIV-related disease
- •5.they have a bleeding diathesis or conditions associated with prolonged
- •bleeding time;
- •6.women who are pregnant, or women able to bear children but not willing
- •to practice acceptable contraception for the duration of the trial (21 days);
- •7.within the past 12 months, they have:
- •·received more than one injection of influenza vaccine;
- •8.within the past 6 months, they have:
- •·had laboratory confirmed influenza disease
- •·received influenza vaccine
- •9.within the past 4 weeks they have received:
- •·another vaccine
- •·any investigational agent
- •10.within the past 7 days, they have experienced:
- •·any acute disease
- •·infections requiring systemic antibiotic or antiviral therapy
- •(chronic antibiotic therapy for urinary tract prophylaxis is
- •acceptable)
- •11.within the past 3 days they have experienced:
- •·fever (i.e., axillary temperature = 38°C);
- •12.they are taking part in another clinical study;
- •13.they have any condition which, in the opinion of the investigator, might
- •interfere with the evaluation of the study objective.
研究者
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