NCT00161850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 1 to 6 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
- 50
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 subjects who completed two vaccinations in one of the three treatment groups of Baxter study 199 (a dose-finding study to investigate the safety and immunogenicity of two vaccinations with FSME IMMUN NEW in healthy subjects aged 1 to 6 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
- 1 Year 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All volunteers who participated in Baxter study 199 and received two vaccinations will be invited to participate. Male and female children will be eligible for participation in this study if:
- •They received two vaccinations with one of the three different dosages of FSME IMMUN NEW during the course of Baxter study 199
- •Written informed consent from the legal guardian is available.
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 199
- •Have had an allergic reaction to one of the components of the vaccine since the last vaccination in Baxter study 199
- •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 199
- •Have had a vaccination against yellow fever and / or Japanese B-encephalitis since the last visit in Baxter study 199
- •Had received an investigational new drug within 6 weeks prior to study start
研究者
研究点 (50)
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