Prevention of cervical, vulvar, and vaginal cancers and related precancers, external genital lesions, Pap test abnormalities, and persistent infection caused by Human Papillomavirus (HPV) 6, 11, 16, 18, 31, 33, 45, 52, and 58. MedDRA version: 17.0 Level: LLT Classification code 10063001 Term: Human papilloma virus infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: GARDASIL
Product Name: GARDASIL
Pharmaceutical Form: Suspension for injection
Current Sponsor code: V501
Other descriptive name: [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18
Sponsors
Merck & Co. Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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: 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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: (1) To evaluate the tolerability of the 9-valent HPV L1 VLP vaccine when administered to 16- to 26-year-old women. (2) To evaluate a formulation of 9-valent HPV L1 VLP vaccine for use in the efficacy evaluation in Part B. (3) To demonstrate that administration of 9-valent HPV L1 VLP vaccine will reduce the combined incidence of HPV 31-, 33-, 45-, 52-, and 58-related persistent infection for a duration of 6 months (within ± 1 month windows) or longer and cervical, vulvar, and vaginal disease compared with GARDASIL™ in 16- to 26-year-old adolescent and young adult women who are seronegative at Day 1 and PCR negative Day 1 through Month 7 to the relevant HPV type. (4) To demonstrate that the 9-valent HPV L1 VLP vaccine induces noninferior GMTs for anti-HPV 6, 11, 16, and 18 compared to GARDASIL™. ;Secondary Objective: To demonstrate that administration of 9-valent HPV L1 VLP vaccine will reduce the combined incidence of HPV 31-, 33-, 45-, 52-, and 58-related documented infection for =12 months and cervical, vulvar, and vaginal disease, compared with GARDASIL™ in 16- to 26-year-old adolescent and young adult women who are seronegative and PCR negative at Day 1 to the relevant HPV type. (2) To evaluate whether the administration of 9-valent HPV L1 VLP vaccine results in a combined incidence of persistent HPV 16 and 18 infection for a duration of 6 months (within ± 1 month windows) or longer and HPV 16- and 18-related cervical, vulvar, and vaginal disease that is observationally comparable to the combined incidence observed with GARDASIL™. See additional objectives in Protocol ;Primary end point(s): The primary efficacy endpoint is the combined incidence of persistent HPV 31, 33, 45, 52, and 58 infection for a duration of 6 months or longer and HPV 31-, 33-, 45-, 52-, and 58-related cervical, vulvar, and vaginal cancer, AIS, CIN 2/3, VIN 2/3, VaIN 2/3, CIN 1, VIN 1, VaIN 1, and condyloma acuminata. | — |
Countries
Austria, Denmark, Germany, Sweden
Outcome results
None listed