EUCTR2007-000440-27-PL进行中（未招募）不适用
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 0.5ML IN ADULTS (FOLLOW UP TO STUDY 223) - TBE Seropersistence Adults
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Baxter AG
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 the preceding Study will be eligible for participation in this study if:
- •· they understand the nature of the study, agree to its provisions and provide written informed consent;
- •· they received the first booster vaccination with FSME-IMMUN 0.5ml during the course of study 223;
- •· blood was drawn after their first booster vaccination in Study 223.
- •Are the trial subjects under 18? no
- •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) yes
- •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 first booster vaccination with FSME-IMMUN 0.5ml;
- •· have a history of infection with or vaccination against other flaviviruses (e.g. dengue fever, yellow fever, Japanese B-encephalitis) since their first booster vaccination with FSME-IMMUN 0.5ml;
- •· are known to be HIV positive (a special HIV test is not required for the purpose of the study) since their first booster vaccination with FSME-IMMUN 0.5ml;
- •· have a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages).
研究者
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