NCT00161863已完成3 期
Open-label Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 试验地点
- 16
研究概览
简要总结
The purpose of this study is to investigate the safety of five consecutive lots of FSME-IMMUN NEW in healthy volunteers. The main criterion for investigation is the fever rate after the first vaccination in three different age classes. The immunogenicity of 0.25 ml FSME-IMMUN NEW has been demonstrated in previous clinical studies in children; therefore, in the present study, immunogenicity was investigated in a subgroup only.
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
- 1 Year 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female children and adolescents will be eligible for participation in this study if:
- •they are aged 1 year (from the 1st birthday) to < 16 years (to the last day before the 16th birthday);
- •they are clinically healthy, (i. e. the physician would have no reservations vaccinating with FSME-IMMUN NEW outside the scope of a clinical trial);
- •their parents/legal guardians understand the nature of the study and agree to its provisions;
- •written informed consent is available from both parents/legal guardians,
- •for Germany/Austria: additional written informed consent is available for children older than 8 years
- •they or their parents/legal guardians agree to keep a volunteer diary.
- •For safety reasons, female volunteers who have reached sexual maturity at study start have to meet the following additional inclusion criteria:
- •negative pregnancy test at study entry;
排除标准
- •Children and adolescents will be excluded from participation in this study if they:
- •have a history of any TBE vaccination;
- •have a history of TBE infection;
- •have a history of allergic reactions to one of the components of the vaccine;
- •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;
- •are known to be HIV positive (a special HIV test is not required for the purpose of the study);
- •have received banked blood or immunoglobulins within one month of study entry;
- •have a history of vaccination against yellow fever and/or Japanese B-encephalitis;
- •suffer from hemorrhagic diathesis;
- •are participating simultaneously in another clinical trial;
- •if female: are pregnant or breastfeeding.
- •Volunteers who meet the inclusion/exclusion criteria, but have a febrile illness (body temperature > 38°C) at the scheduled time of vaccination, will not be vaccinated before their body temperature returns to normal.
- •Volunteers who have received any other vaccination within 4 weeks prior to visit 1 will not be vaccinated until an interval of 4 weeks has passed. In this case visit 1 will take place separately.
- •If volunteers have received antipyretics within 4 hours prior to the intended TBE vaccination, the vaccination should be performed at a later time.
- •Volunteers who have a positive TBE antibody value prior to the first vaccination will be excluded from the statistical analysis of the primary endpoint.
研究者
研究点 (16)
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