NCT00161876已完成3 期
Open-label, Multicenter, Follow-up Phase III Study to Investigate the Safety of the Third Vaccination of FSME-IMMUN NEW in Volunteers Aged 16 to 66 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
- 3,973
- 试验地点
- 16
研究概览
简要总结
The aim of this study is to evaluate the safety of the third vaccination with FSME-IMMUN NEW in all volunteers who received both vaccinations in Baxter study 208 (safety study of FSME IMMUN NEW and ENCEPUR in healthy volunteers aged 16 to 65 years).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 66 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Received two vaccinations during the course of Baxter study 208
- •Understand the nature of the study, agree to its provisions and give written informed consent
- •For volunteers under 18 years of age - written informed consent of the parents/legal guardian is given
排除标准
- •Volunteers assessed for eligibility to receive a third vaccination.
- •Eligibility to receive third vaccination:
- •ELISA value > 126 VIE U/ml before the first TBE vaccination in Baxter study 208
- •Not clinically healthy, (i.e. the physician would have reservations vaccinating with FSME-IMMUN NEW outside the scope of a clinical trial)
- •Have already been administered a third TBE vaccination elsewhere since receiving the two vaccinations in Baxter study 208
- •Have had an allergic reaction to one of the components of the vaccine since the last vaccination in Baxter study 208
- •Suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions
- •Have a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent dose of other alcoholic beverages)
- •Have received banked human blood or immunoglobulins within one month of study entry
- •Are known to have become infected with HIV (a special HIV test is not required for the purpose of the study) since the last visit of study 208
- •Have had a vaccination against yellow fever and / or Japanese B-encephalitis since the last visit in study 208
- •Have received an investigational new drug within 6 weeks prior to study start
- •Have a positive pregnancy test at the first medical examination (for females capable of bearing children)
- •Do not agree to employ adequate birth control measures for the duration of the study (for females capable of bearing children)
研究者
研究点 (16)
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