NCT00163618已完成不适用
Multicenter Phase IV Study to Investigate the Seropersistence of TBE Virus Antibodies Approx. 3 Years After a Booster Vaccination With FSME-IMMUN 0.25 mL JUNIOR in Children
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 试验地点
- 4
研究概览
简要总结
The objective of this study is to assess the TBE antibody persistence approximately three years after administration of a TBE booster vaccination with FSME-IMMUN 0.25 ml Junior in children who received either 0.25 mL or 0.5 mL TicoVac for their primary vaccination series in Study 146A.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 7 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female children who participated in Study 146A if:
- •they and/or their parents/legal guardians understand the nature of the study and agree to its provisions
- •written informed consent is available from the child (according to age and capacity of understanding) and the parents/legal guardians
- •they received the complete 3-immunization primary vaccination series with either 0.5 ml or 0.25 ml TicoVac in Study 146A
- •they received FSME-IMMUN 0.25 ml Junior for their first booster vaccination approximately 3 to 4 years after their third vaccination in Study IMAG-146A
排除标准
- •Subjects who received any further TBE vaccination since their first TBE booster vaccination
- •Subjects with a history of infection with, or vaccination against, other flaviviruses (e.g. dengue fever, yellow fever and/or japanese B encephalitis virus) since their third vaccination in Study 146A
- •Subjects who have suffered from a disease (e.g. autoimmune disease) or have undergone a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions within 30 days before and after their first TBE booster vaccination
- •Subjects who have been known to be HIV positive (a special HIV test is not required for the purpose of the study) since their third vaccination in Study 146A
- •Subjects who have received a blood transfusion or immunoglobulins within 30 days of study entry
研究者
研究点 (4)
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