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
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