CTRI/2009/091/000767已完成3 期
A Phase III Clinical Trial to Study the Immunogenicity, Tolerability, and Manufacturing Consistency of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (9 to 15 Year Olds) With a Comparison to Young Women (16 to 26 Year Olds)
Merck Sharp and Dohme0 个研究点目标入组 2,800 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,800
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
入选标准
- •Boys and Girls Age 9 to 15:
- •?Subject is not sexually active
- •Women Age 16 to 26:
- •?Subject has never had Pap testing or has had only normal results
- •?Subject has had 0 to 4 sexual partners at the time of enrollment
排除标准
- •Boys and Girls Age 9 to 15:
- •?History of allergic reaction that required medical intervention
- •?Currently enrolled in any other clinical study
- •?Subject is pregnant
- •?Subject is immunocompromised or has taken immunosuppressants in the last year
- •?Subject has received a marketed HPV vaccine or participated in an HPV vaccine clinical trial
- •?Subject has a history of positive test for HPV
- •Women Age 16 to 26:
- •?History of allergic reaction that required medical intervention
- •?Currently enrolled in any other clinical study
- •?Subject is pregnant
- •?Subject is immunocompromised or has taken immunosuppressants in the last year
- •?Subject has received a marketed HPV vaccine or participated in an HPV vaccine clinical trial
- •?Subject has a history of positive test for HPV
- •?Subject has a history of abnormal cervical biopsy result
- •?Subject has a history of external genital lesions
研究者
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已完成
不适用
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