EUCTR2009-009324-36-PL进行中（未招募）1 期
OPEN-LABEL PHASE IV STUDY TO INVESTIGATE THE SEROPERSISTENCE OF TICK-BORNE ENCEPHALITIS (TBE) VIRUS ANTIBODIES AFTER THE FIRST BOOSTER AND THE RESPONSE TO A SECOND BOOSTER VACCINATION WITH FSME-IMMUN IN CHILDREN, ADOLESCENTS AND YOUNG ADULTS(FOLLOW UP TO STUDY 700401) - TBE SEROPERSISTENCE AFTER FIRST BOOSTER IN CHILDREN (FOLLOW-UP TO STUDY 700401)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 202
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 700401 and meet ALL of the following criteria are eligible for participation in this study:
- •Subject / 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 received the first booster vaccination with either FSME-IMMUN 0.25 ml Junior or FSME-IMMUN 0.5 ml during the course of Study 700401;
- •Blood was drawn after the first booster vaccination in Study 700401;
- •Subject / parent(s) / legal guardian(s) understand(s) the nature of the study and is / are willing to comply with the requirements of the protocol (e.g. return for follow-up visits, completion of the Subject Diary).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 202
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 32
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects who participated in Study 700401 and meet ANY of the following criteria are not eligible for participation in this study:
- •Subject received any TBE vaccination since his / her first booster vaccination in Study 700401;
- •Subject has a history of infection with or vaccination against other flaviviruses (e.g. Dengue fever, yellow fever, Japanese B encephalitis) since his / her first booster vaccination in Study 700401;
- •Subject is known to be HIV positive (a special HIV test is not required for the purpose of the study) since his / her first booster vaccination in Study 700401;
- •Subject received a blood product or immunoglobulins within 90 days before the blood draw or in the period between blood draw and the booster vaccination (as applicable);
- •Subject has a known or suspected problem with drug or alcohol abuse (> 4 liters of wine/week or equivalent level of other alcoholic beverages);
- •Subject / parent(s) / legal guardian(s) is / 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 the site conducting the study.
研究者
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