A Randomized, International, Double-Blinded (With In-House Blinding), Controlled With GARDASIL™, Dose-Ranging, Tolerability, Immunogenicity, and Efficacy Study of a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered to 16- to 26-Year-Old Women.

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., USA0 个研究点目标入组 14,620 人开始时间: 2009年2月6日最近更新: 2016年8月8日

适应症

试验速览

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•1.Subject is female, between the ages of 16 years and 0 days and 26 years and 364 days on the day of randomization.
•2.Subject has never had Pap testing or has only had normal Pap test results.
•3.The subject has the following lifetime sexual history at the time of enrollment:
•a)Subject has had 1 to 4 male and/or female sexual partners; or
•b)Subject has had 0 male and/or female sexual partners, is 18 years of age or older, and plans to become sexually active within the first 3 - 6 months of the study.
•4.Since the first day of the subject’s last menstrual period through Day 1, the subject has not had sex with males or has had sex with males and used effective contraception with no failures (an example of a failure is a male condom that ruptures during sexual intercourse).
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.Subject has a history of an abnormal cervical biopsy result (showing cervical intraepithelial neoplasia [CIN] or worse).
•2.Subject has a history of a positive test for HPV.
•3.Subject has received a marketed HPV vaccine, or has participated in an HPV vaccine clinical trial and has received either active agent or placebo.
•4.Subject is pregnant (as determined by a serum pregnancy test or urine pregnancy test that is sensitive to 25 mIU/mL ß-hCG).
•5.Subject has a history of or clinical evidence at the Day 1 pelvic examination of HPV-related external genital lesions (e.g., condyloma acuminata or vulvar intraepithelial neoplasia [VIN]) or external genital cancer, HPV-related vaginal lesions (e.g., condyloma acuminata or vaginal intraepithelial neoplasia [VaIN]) or vaginal cancer.

发起方

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., USA