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临床试验/CTIS2022-500906-17-01
CTIS2022-500906-17-01招募中1 期

INfluenza VaccInation To mitigate typE 1 Diabetes (INVITED trial) - INVITED-2022

Aarhus University Hospital0 个研究点目标入组 100 人开始时间: 2022年6月24日最近更新:
适应症

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
100

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
0 至 17(—)
性别
All

入选标准

  • Patients hospitalized with newly diagnosed type 1 diabetes mellitus., Male or female subjects =7 and <18 years., Written informed consent (parents, legal guardian).

排除标准

  • Influenza vaccination during the current influenza season (September 1 – March 1)., Strong indication for influenza vaccination for non-diabetic disease., Severe allergy to eggs or previous allergic reaction to influenza vaccine., Suspicion of febrile illness or acute, ongoing infection., Hypersensitivity to the active substances or ingredients of Vaxigrip Tetra or against any residues, such as eggs (ovalbumin or chicken proteins), neomycin, formaldehyde and octoxinol., Patients with endogenic or iatrogenic immunosuppression that may result in reduced immunization response., Inability to provide informed consent., Age <7 or =18 years., Previous randomization in the INVITED trial.

研究者

发起方
Aarhus University Hospital

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