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临床试验/CTIS2022-500256-37-00
CTIS2022-500256-37-00进行中(未招募)1 期

A Phase 3 International, Multicenter, Open-label Study to Evaluate the Safety and Immunogenicity of 9vHPV Vaccine Administered as 2-dose Regimen with Extended Dosing Intervals in 9- to 14-Year Old Boys and Girls Compared with a Standard 3-dose Regimen in 16- to 26-Year Old Women - V503-069

Merck Sharp & Dohme Corp.0 个研究点目标入组 700 人开始时间: 2022年5月17日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
700

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

年龄范围
0 至 64(—)
性别
All

入选标准

  • Boys and girls 9 to 15 years must not have had coitarche and do not plan on becoming sexually active during the vaccination period, Women 16 to 26 years who have never had a Papanicolaou (Pap) test or only have had normal Pap test results, Women 16 to 26 years with a lifetime history of 0 to 4 male and/or female sexual partners, Cohort 0 participants must have received 1 dose of 9vHPV vaccine at least 1 year prior to enrollment and did not receive a second dose of any HPV vaccine

排除标准

  • Known allergy to any vaccine component, Received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial (Cohorts 1-5), History of severe allergic reaction that required medical intervention, Thrombocytopenia or any coagulation disorder, Females only: participant is pregnant or expecting to donate eggs during day 1 through month 7, Currently immunocompromised, or been diagnosed with immunodeficiency, Had a splenectomy, Receiving or has received immunosuppressive therapies within the last year, Received any immunoglobulin product or blood-derived product within 3 months, Has received more than 1 dose of an HPV vaccine (Cohort 0)

研究者

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