EUCTR2006-002649-35-GB进行中（未招募）1 期
A Phase IV, Single-Centre, Observer-Blind, Controlled, Randomized Study to Compare the Safety and Immunogenicity of Fluvirin® to Influvac® Administered to Healthy Children 3 to 12 Years of Age. - Fluvirin Paediatric Trial
ovartis Vaccines and Diagnostics S.r.l.0 个研究点目标入组 0 人开始时间: 2006年9月29日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 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
- •Subjects eligible for enrollment into this Phase IV trial are male and female paediatric subjects who are:
- •1) children of 3 years to <12 years of age, whose parents or legal guardians have given written informed consent prior to study entry
- •2) available for all the visits scheduled in the study
- •3) in good health as determined by:
- •a. medical history,
- •b. physical examination,
- •c. clinical judgment of the investigator.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •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 including, for example:
- •a. cancer (except for benign or localized skin cancer not presently treated with chemotherapy)
- •b. autoimmune disease (including rheumatoid arthritis),
- •c. advanced arteriosclerotic disease or complicated diabetes mellitus,
- •d. chronic obstructive pulmonary disease (COPD) that requires oxygen therapy,
- •e. acute or progressive hepatic disease,
- •f. acute or progressive renal disease
- •g. congestive heart failure
- •2) they have a history of any anaphylaxis, serious vaccine reactions, they are hypersensitive to ovalbumin, chicken protein, chicken feathers, influenza viral protein, thiomersal, neomycin or polymyxin or any other component of the vaccine
- •3) they have a known or suspected impairment/alteration of immune function, resulting from:
- •a. receipt of immunosuppressive therapy (corticosteroids -except topical or inhaled steroids- or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study
- •b. receipt of immunostimulants
- •c. high risk for developing an immunocompromising disease (suspected or known HIV infection or HIV-related disease)
- •4) receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study;
- •5) within the past six months they have had laboratory confirmed influenza disease
- •6) have ever received influenza vaccine
- •7) within the past four weeks they have received another vaccine or any investigational agent
- •8) 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);
- •9) within the past 3 days they have experienced fever (defined as axillary temperature =38°C)
- •10) any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
- •11) participation to another clinical trial
研究者
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