NCT00161954已完成4 期
Open Phase IV Clinical Study to Evaluate the Immunogenicity and Safety of a Rapid Immunization Schedule With FSME-IMMUN 0.5 mL in Healthy Adults Aged 16 - 65 Years
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 试验地点
- 2
研究概览
简要总结
The objective of this study is to establish the earliest time point at which vaccines are expected to show seropositive antibody levels after vaccination with FSME-IMMUN 0.5 mL using a rapid immunization schedule (2 vaccinations administered 12 +/- 2 days apart.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Understanding the nature of the study, agreement to its provisions and written informed consent
- •Written informed consent of subject´s parents / legal guardians (if subject is under 18 years of age)
- •Aged >= 16 years (from the 16th birthday) to <= 65 years (to the last day before the 66th birthday)
- •Clinically healthy, (i. e. the physician would have no reservations vaccinating with FSME-IMMUN 0.5 ml outside the scope of a clinical trial)
- •Negative pregnancy test result at the first medical examination (if female and capable of bearing children)
- •Agreeing to employ adequate birth control measures for the duration of the study (if female and capable of bearing children)
- •Agreeing to keep a subject diary.
排除标准
- •History of any previous TBE vaccination
- •History of TBE infection
- •History of infection with other flaviviruses
- •History of vaccination against yellow fever and/or Japanese B-encephalitis
- •History of allergic reactions, in particular to one of the components of the vaccine
- •Suffering from a disease (e.g. autoimmune disease) or undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions
- •Known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages)
- •Donation of blood or plasma within one month of study start
- •Having received a blood transfusion or immunoglobulins within one month of study entry
- •HIV positivity (an HIV test is not required specifically for the purpose of this study
- •Simultaneous participation in another clinical trial including administration of an investigational product
- •Participating in any other clinical study within six weeks prior to study start
- •Participated in another Baxter vaccine study within the last six months (with the exception of follow-up studies)
- •Pregnancy or lactation (if female)
- •Having received any other vaccination within two weeks prior to study entry
研究者
研究点 (2)
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