NCT00161889已完成2 期
Follow-up Study to Investigate the Safety and Immunogenicity of a Third Vaccination With Three Different Antigen Concentrations of FSME IMMUN NEW in Children Aged 6 to 16 Years
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 615
- 试验地点
- 38
研究概览
简要总结
The purpose of this study is to investigate the safety and immunogenicity of the third vaccination with one of three different concentrations of a TBE vaccine in all volunteers who completed two vaccinations in one of the three treatment groups of Baxter study 205 (safety and immunogenicity of two vaccinations with FSME IMMUN NEW in healthy volunteers aged 6 to 16 years).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •There are no specific exclusion criteria for this study entry. However volunteers will be assessed for eligibility to receive a third vaccination.
- •Volunteers will be excluded from vaccination and consecutive visits in this study if they:
- •Are 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 after the two vaccinations in Baxter study 205
- •Have had an allergic reaction to one of the components of the vaccine since the last vaccination in Baxter study 205
- •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 received banked human blood or immunoglobulins within one month of study entry
- •Are known to be HIV positive (a special HIV test is not required for the purpose of the study) since the last visit of Baxter study 205
- •Have had a vaccination against yellow fever and / or Japanese B-encephalitis since the last visit in Baxter study 205
- •Had received an investigational new drug within 6 weeks prior to study start
- •If female and capable of bearing children - have a positive pregnancy test at the first medical examination
研究者
研究点 (38)
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