EUCTR2007-003528-39-SEActive, not recruitingNot Applicable
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.0 sites14,620 target enrollmentStarted: January 21, 2009Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 14,620
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •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 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: 2658
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 11962
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •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.
Investigators
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