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临床试验/JPRN-jRCT1080223795
JPRN-jRCT1080223795已完成Unknown

TRIBIK Drug Use Surveillance

The Research Foundation for Microbial Diseases of Osaka University0 个研究点目标入组 921 人开始时间: 2018年2月2日最近更新:

试验速览

阶段
Unknown
状态
已完成
入组人数
921

研究概览

简要总结

The incidence of adverse reactions in 869 subjects included in the safety analysis was 55.35%, and no significant adverse reactions were reported. There were no occurrence of shock, anaphylaxis, or vasovagal syncope. The results of this surveillance did not identify any new safety concern to be included in the RMP.

研究设计

研究类型
Observational

入排标准

年龄范围
>= 90month old 至 ot applicable(—)
性别
All

入选标准

  • Vaccinees who meet both of the following conditions [1] and [2]:
  • [1] Vaccinees who received TRIBIK at the age of 90 months and over.
  • [2] Vaccinees who are able to participate in a questionnaire survey on the health status after vaccination with TRIBIK ( or vaccinees whose guardians are able to participate in the questionnaire survey).

排除标准

  • 未提供

研究者

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