NL-OMON38280已完成4 期
Response to hepatitis A and B vaccine among children with immunesuppression due to either hiv or immunesuppressive medication - Ambirixresponse immunesuppressed children
Geneeskundige en Gezondheidsdienst (GGD) Amsterdam0 个研究点目标入组 250 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 17（—）
入选标准
- •All children from 1 up to and including 15 years of age, known with:
- •- hiv-infection irrespective of treatment status. The most recent tested CD4 T cell percentage should be 15% or higher (group 1); OR:
- •- juvenile idiopathic arthritis, for which one or more of the following treatments is used (orally or systemically) for at least 3 months: Prednis(ol)on >= 0.25 mg/ kg body weight, or another corticosteroid in equivalent dosage; Etanercept (Enbrel®); Infliximab (Remicade®); Methotrexaat (Emthexate® or Metoject®) (group 2)
- •are eligible for inclusion.
排除标准
- •Not eligible for inclusion are:
- •- children who have received one or more vaccinations against hepatitis A and hepatitis B before;
- •- children who have been infected with hepatitis A and hepatitis B (serologically proven);
- •- children who received immunoglobulins within 6 months prior to study entrance.
- •- children known with a blood clotting disorder which prohibits intramuscular administration of the vaccine.
研究者
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Response to hepatitis A and B vaccine among children with immunesuppression due to either hiv or immunesuppressive medication - Ambirixresponse immunesuppressed childreThe effectiveness of Ambirix will be investigated in 2 groups:1) children with hiv-infection, with CD4 counts > 15%2) children with a rheumatic disease for which immune-suppressive medication is used.MedDRA version: 9.1Level: LLTClassification code 10002725Term: Anti-HIV positiveMedDRA version: 9.1Level: LLTClassification code 10059176Term: Juvenile idiopathic arthritisEUCTR2008-003280-40-NLPublic Health Service Amsterdam
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