EUCTR2010-020097-42-AT进行中（未招募）不适用
Open Phase IV Clinical Study to Evaluate the Immunogenicity and Safety of a Rapid Immunization Schedule with FSME-IMMUN 0.25ml JUNIOR in Healthy Children aged 1 to below 15 Years - Pediatric Rapid TBE Immunization Study
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 240
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
- •Subject is = 1 year (from the 1st birthday) to below 15 years (to the last day before the 15h birthday) old at the time of screening;
- •Subject’s parent(s) / legal guardian(s) provide(s) written informed consent (according to national law);
- •Subject provides written assent to the study according to age and capacity of understanding;
- •Subject / parent(s) / guardian(s) understand(s) the nature of the clinical study and is / are willing to comply with the requirements of the protocol (e.g., completion of the Subject Diary, return for follow-up visits);
- •Subject is generally healthy (i.e. the physician would have no reservations vaccinating with a TBE vaccine outside the scope of a clinical study);
- •If female of childbearing potential, subject presents with a negative urine pregnancy test within 24 hours prior to the first vaccination and agrees to employ adequate birth control measures for the duration of the study;
- •Subject is physically and mentally capable of participating in the study.
- •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
- •Subject has a history of any previous TBE vaccination or infection;
- •Subject has a history of infection with other flaviviruses;
- •Subject has a history of vaccination against Yellow fever and/or Japanese B encephalitis;
- •Subject has a history of severe allergic reactions, in particular a known sensitivity or allergy to any components of the vaccines;
- •Subject has a disease (e.g. autoimmune disease) or is undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions;
- •Subject has received any blood product or immunoglobulins within 90 days prior to study entry;
- •Subject has a history of testing positive for Human Immunodeficiency Virus (HIV), Hepatitis B Surface Antigen (HBsAg) or Hepatitis C Virus (HCV). No confirmatory testing for previous infection with these viruses will be conducted as part of this study;
- •Subject has a functional or surgical asplenia;
- •Subject has a rash, dermatologic condition or tattoos which might interfere with injection site reaction rating;
- •Subject or one of subject’s parent(s) / legal guardian(s) are in a dependent relationship with the study investigator or with a study team member. Dependent relationship includes close relatives (i.e., children or grandchildren, partner/spouse, siblings) as well as employees of the investigator or site personnel conducting the study.
- •If female, subject is pregnant or lactating at the time of study enrollment.
- •Subject has participated in another clinical study involving an investigational product (IP) or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an IP or device during the course of this study.
研究者
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