EUCTR2005-000767-26-AT进行中（未招募）不适用
Open-label follow-up study to investigate the seropersistence of TBE antibodies and the booster response to a tick-borne encephalitis vaccine in children and adolescents aged 3 - 18 years. - TBE antibody persistence and booster vaccination study in children and adolescents
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Baxter AG
- 入组人数
- 375
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 who participated in study 209 will be eligible for participation in this study if:
- •- They and/or their parents / legal guardians understand the nature of the study and agree to its provisions;
- •- Written informed consent is available from the parents / legal guardians according to national law;
- •- Written informed assent is available from the child/adolescent according to age and capacity of understanding;
- •- They received the third vaccination with FSME-IMMUN 0.25 ml during the course of study 209;
- •- Blood was drawn after their third vaccination during the course of study 209;
- •- They showed an ELISA concentration > 126 VIE U/ml and / or a NT titer >= 10 after the third vaccination in study 209;
- •- They or their parents / legal guardians agree to keep a Subject Diary.
- •Are the trial subjects under 18? yes
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects will be excluded from participation in this study if they:
- •- received any TBE vaccination since their third vaccination with FSME-IMMUN 0.25 ml;
- •- have a history of infection with or vaccination against other flaviviruses (Dengue fever, yellow fever and / or Japanese B-encephalitis virus) since their third vaccination with FSME-IMMUN 0.25 ml;
- •- are known to be HIV positive (a special HIV test is not required for the purpose of the study) since their third vaccination with FSME-IMMUN 0.25 ml;
- •- received a blood transfusion or immunoglobulins within 30 days of the first and second blood draw (as applicable);
- •- have a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages);
- •- have participated in another Baxter vaccine study within the last six months (with the exception of follow-up studies).
- •Subjects will not be eligible for the booster vaccination if they:
- •- do not meet the inclusion / exclusion criteria;
- •- are not clinically healthy, (i.e. the physician would have reservations vaccinating with a TBE vaccine outside the scope of a clinical trial);
- •- suffer 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;
- •- have shown an allergic reaction to one of the components of the vaccine since their third vaccination in study 209;
- •- have donated blood or plasma within 30 days to the booster vaccination;
- •- if female of childbearing potential - are pregnant or breastfeeding before the booster vaccination (positive pregnancy test result at the medical examination before the booster vaccination);
- •- are simultaneously participating in another clinical trial including administration of an investigational product within six weeks prior to the booster vaccination until the end of the study.
- •Subjects who meet the inclusion/exclusion criteria, but have a febrile illness (body temperature >= 38.0°C, measured orally) at the scheduled time of vaccination, will not be vaccinated until their body temperature returns to normal.
研究者
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