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临床试验/CTRI/2015/09/006183
CTRI/2015/09/006183已完成4 期

A Post Marketing Surveillance to assess the safety of Gardasil® in females of 9 to 45 years in routine clinical care - NA

MSD Pharmaceuticals PvtLtd0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
已完成
发起方

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

入选标准

  • Subjects who provide voluntary written informed consent/ assent to participate in the study.
  • Female subjects 9 to 45 years (inclusive) who opt for vaccination.
  • Subjects who would receive Gardasil® according to the approved local prescribing information as per the Investigatorâ??s opinion.
  • Subjects who the investigator believes that they or their parents/ guardians can and will comply with the requirements of the protocol.
  • Subjects should own a phone so as to enable the investigator or qualified designee to call the subject for safety follow-up.

排除标准

  • Subjects having a history of known prior vaccination with a HPV vaccine prior to signing informed consent for participation in this surveillance
  • Subjects who were previously enrolled in HPV vaccine surveillance and received a similar active agent or placebo.
  • Subjects who have received any investigational product within 30 days prior to their first visit.
  • Any condition which in the opinion of the investigator might interfere with the evaluation of the surveillance objectives.

研究者

发起方
MSD Pharmaceuticals PvtLtd

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