EUCTR2007-000810-35-CZ进行中（未招募）1 期
Open Phase IV Clinical Study to Evaluate the Immunogenicity and Safety of a Rapid Immunization Schedule with FSME-IMMUN 0.25 ml JUNIOR in Healthy Children aged 3 - 15 Years
BIOVOMED0 个研究点目标入组 300 人开始时间: 2007年3月27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
- 300
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
- •- the written informed consent of their parents / legal guardians
- •- with their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits)
- •- aged > 3 years (from the 3rd birthday) to < 15 years (to the last day before the 16th birthday);
- •- clinically healthy, (i. e. the physician would have no reservations vaccinating with FSME-IMMUN 0.25 ml JUNIOR outside the scope of a clinical trial);
- •- negative pregnancy test result at the first medical examination (if female and capable of bearing children);
- •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
- •- history of any previous TBE vaccination;
- •- history of TBE infection or other flaviviruses;
- •- history of vaccination against yellow fever and/or Japanese B-encephalitis;
- •- history of allergic reactions, in particular to one of the components of the vaccine;
- •- suffering from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions;
- •- blood transfusion or immunoglobulins within one month of study entry;
- •- known HIV positivity (an HIV test is not required)
- •- simultaneously participation in another clinical trial
研究者
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