NCT00161785已完成4 期
Investigation of the Seropersistence of TBE Antibodies and the Booster Response to FSME-IMMUN 0.5 ml in Adults Aged 18 - 67 Years
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 340
- 试验地点
- 2
研究概览
简要总结
The purpose of this study is to assess:
- TBE antibody persistence 2 and 3 years after the third TBE vaccination with FSME-IMMUN 0.5ml by means of ELISA and neutralization test (NT).
- TBE antibody response to a booster vaccination with FSME-IMMUN 0.5ml, by means of ELISA and NT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects 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 third vaccination with FSME-IMMUN 0.5ml during the course of Baxter Study 213;
- •blood was drawn before and after their third vaccination during the course of Baxter Study 213;
- •they showed an ELISA-concentration > 126 VIE U/ml and / or a NT-titer >= 1:10 after the third vaccination in Baxter Study 213;
- •they agree to keep a Subject Diary.
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 0.5ml;
- •received a vaccination against yellow fever and / or Japanese B-encephalitis since their third 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 third 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);
- •have received a blood transfusion or immunoglobulins within one month to the first and second blood draw;
- •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 booster vaccination if:
- •they do not meet the inclusion/exclusion criteria;
- •they are not clinically healthy, (i.e. the physician would have reservations vaccinating with FSME-IMMUN 0.5ml outside the scope of a clinical trial);
- •they 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;
- •they have donated blood or plasma within one month to the booster vaccination;
- •female of childbearing potential are pregnant or breastfeeding before the booster vaccination (positive pregnancy test result at the medical examination before the booster vaccination);
- •they have shown an allergic reaction to one of the components of the vaccine since their third vaccination in Baxter Study 213;
- •they 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.
- •Subjects who have received any vaccination within two weeks prior to the booster vaccination will not be vaccinated until an interval of two weeks has passed.
- •If subjects have received antipyretics within 4 hours prior to the intended TBE vaccination, the vaccination should be performed at a later time.
研究者
研究点 (2)
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