CTRI/2013/09/004012进行中（未招募）3 期
A Phase III Clinical Trial to Study the Immunogenicity, Tolerability, anManufacturing Consistency of V503 (A Multivalent Human Papillomav[HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents andAdolescents (9 to 15 Year Olds) With a Comparison to Young Womento 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
- 进行中（未招募）
- 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
- •Inclusion Criteria:
- •Boys and Girls Age 9 to 15:
- •Participant has not had sexual intercourse prior to the study and does not plan to become sexually active during the study period Day 1 to Month 7
- •Please note that this is an extension study (V503-002 EXT1) which will collect safety and immunogenicity information through Month 36 for patients in the age group of 9-15 years . No study vaccine will be administered in the extension study. Subjects enrolled in the 16- to 26-year-old cohort in the base study will not be included in the EXTENSION STUDY.
排除标准
- •Exclusion Criteria:
- •Boys and Girls Age 9 to 15:
- •History of allergic reaction that required medical intervention
- •Currently enrolled in any other clinical study
- •Participant is pregnant
- •Participant is immunocompromised or has taken immunosuppressants in the last year
- •Participant has received a marketed HPV vaccine or participated in an HPV vaccine clinical trial
- •Participant has a history of positive test for HPV.
- •Only patients in the age group of 9-15 years of age ( Male and female ) would be included in the study. All other age groups are excluded in the extension study.
研究者
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