NCT00161824已完成3 期
Single-blind, Randomized, Multicenter Comparison of FSME IMMUN NEW and ENCEPUR: Safety and Tolerability of Two Vaccinations in Healthy Volunteers Aged 16 to 65 Years.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 3,800
- 试验地点
- 14
研究概览
简要总结
The purpose of this study is to assess the safety of a vaccination schedule consisting of two vaccinations (21-35 days apart) with the tick-borne encephalitis (TBE) vaccine FSME-IMMUN NEW (5 consecutive lots) in comparison to another licensed TBE vaccine (Encepur® adults, with polygeline) (2 lots) in healthy volunteers aged 16 to 65 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female volunteers were eligible for participation in this study if they:
- •Were 16 years (from the 16th birthday) to 65 years (to the last day before the 65th birthday) old
- •Were clinically healthy
- •Had a negative pregnancy test at the first medical examination, if female and capable of bearing children
- •Agreed to employ adequate birth control measures for the duration of the study, if female and capable of bearing children
- •Provided written informed consent
- •For volunteers under 18 years of age - written informed consent of the parents / guardian was available
- •Agreed to keep a volunteer diary
排除标准
- •History of any previous TBE vaccination
- •History of TBE infection or show evidence of latent TBE infection (as demonstrated by screening ELISA > 126 VIEU/ml)
- •History of allergic reactions, in particular to one of the components of the vaccine
- •Previously received volume substitution with a product containing polygeline (stabilizer in ENCEPUR)
- •Received antipyretics within 4 hours prior to the first TBE vaccination
- •Suffer from a disease that cannot be effectively treated or stabilized
- •Suffering from a disease (e.g. autoimmune disease) or were undergoing any form of treatment that could be expected to influence immunological functions
- •Suffering from chronic, degenerative and/or inflammatory disease of the central nervous system
- •Using any immunosuppressive drugs (e.g. local or systemic corticosteroids, chemotherapeutics)
- •Had a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages)
- •Had donated blood or plasma within one month of the study start
- •Had received banked blood or immunoglobulins within one month of study entry
- •Known to be HIV positive (a special HIV test was not required for the purpose of the study)
- •Suffering from a febrile illness at study entry
- •History of vaccination against yellow fever and / or Japanese B encephalitis
- •Participating simultaneously in another clinical trial
- •If female: pregnant or breast feeding
研究者
研究点 (14)
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