DRKS00016357已完成不适用
Tolerability, Safety, and Efficacy of Varicella-zoster-virus vaccination in immunosuppressed children with inflammatory bowel disease or autoimmunhepatitis - VARICED
Klinik für Kinder- und JugendmedizinUniversitätsklinikum Ulm0 个研究点目标入组 366 人开始时间: 2019年1月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 366
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2 Years 至 18 Years(—)
- 性别
- All
入选标准
- •As this is an observational study no inclusion criteria are defined. In principal, patients with chronic inflammatory bowel disease or autoimmune hepatitis being in steady state of their disease and having the indication of varicella vaccination due to insufficient protection against varicella can participate.
排除标准
- •As this is an observational study no exclusion criteria are given for this study. Basically the recommendations from the enclosed leaflet have to be followed.
- •In addition, we made some recommendations in our observational protocol.
- •1) We need a parent or patient consent to collect and analyze the data in this study.
- •2) If the patient is suspicious for an immunodeficiency this should be clarified first.
- •3) In addition to the leaflet we do not recommend immunization during an active underlying disease
- •4) Furthermore, we specified some conditions that may affect safety and efficiency, which should be avoided. In detail these conditions are stated in the observational protocol.
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