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临床试验/jRCTs031190014
jRCTs031190014已完成不适用

Effectiveness of the measles and rubella live attenuated vaccination for pediatric patients treated with not high dose corticosteroid (Effectiveness of the measles and rubella live attenuated vaccination for pediatric patients treated with not high dose corticosteroid)

未提供0 个研究点目标入组 40 人开始时间: 待定最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
40
主要终点
-

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Single Arm Study
干预模型
Single Assignment
主要目的
Prevention Purpose
盲法
Open(masking Not Used)

入排标准

年龄范围
5age old over 至 15age old not(—)
性别
All

入选标准

  • Aged from 5 years old to under 15 years old
  • Current treatment with steroids the dose of which satisfies all of the following
  • Less than 1mg/kg/day or 2mg/kg/day
  • Less than 20mg/day
  • No increase in steroids more than 4 weeks or 28 days
  • Patients of inoculation with MR vaccine once at a year old or over

排除标准

  • Current treatment with high dose immunosuppressive agents
  • Definition of high dose immunosuppressive agents is as follows
  • Salazosulfapyridine more than 40mg/kg/day
  • Leflunomide more than 0.25mg/kg/day
  • Methotrexate more than 15mg/m2/week
  • Cyclosporine more than 2.5mg/kg/day
  • Tacrolimus more than 0.06mg/kg/day
  • Azathioprine more than 1mg/kg/day
  • Cyclophosphamide more than 0.5mg/kg/day
  • 6-Mercaptopurine more than 1.5mg/kg/day
  • Cases with side effect requiring treatment at the time of MR vaccination in the past
  • Cases with febrile disease within 4 weeks prior to vaccination
  • Cases receiving transfusion or administration of biological products within 3 months prior to vaccination
  • Cases receiving other live attenuated vaccine within 4 weeks or 28 days
  • Cases receiving inactivated vaccine within 6 days
  • Cases diagnosed as primary immunodeficiency disease
  • Cases likely to require treatment enhancement within 4 weeks after vaccination
  • Cases in whom both of measles and rubella antibody titers were higher than criteria
  • Cases living with a pregnant woman

结局指标

主要结局

-

Positive sero-conversion rate of specific virus antibody after vaccination

次要结局

未报告次要终点

研究者

发起方
未提供

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