Prevention of cervical, vulvar, and vaginal cancers and related precancers, external genital lesions, and persistent infection caused by Human Papillomavirus (HPV) 6, 11, 16, 18, 31, 33, 45, 52, and 58 via concomitant administration of GARDASIL™ with prophylactic 5-valent HPV (Types 31, 33, 45, 52, 58) L1 virus-like particle (VLP) vaccine2. MedDRA version: 9.1 Level: LLT Classification code 10063001 Term: Human papilloma virus infection
Conditions
Interventions
Product Name: Pentavalent HPV VLP Vaccine
Product Code: V504
Pharmaceutical Form: Syrup
Current Sponsor code: V504
Other descriptive name: Pentavalent HPV VLP Vaccine
Concentration unit: ml millilitre
Sponsors
Merck Sharp & Dohme (Sweden) AB
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 had 0 to 4 male and/or female sexual partners. 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? no 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 5-valent HPV L1 VLP vaccine when administered concomitantly with GARDASIL™ to 16- to 26-year-old women. 2. To demonstrate that administration of the 5-valent HPV L1 VLP vaccine concomitantly with GARDASIL™ (different injection sites in separate arms) induces non-inferior Geometric Mean Titers (GMTs) for anti-HPV 6, 11, 16, and 18 compared to GARDASIL™ administered concomitantly with placebo. ;Secondary Objective: To demonstrate that 5-valent HPV L1 VLP vaccine is immunogenic with respect to HPV types 31, 33, 45, 52, and 58. ;Primary end point(s): The important variables for safety/tolerability are the incidences of severe injection-site reactions and any vaccine-related serious adverse experiences. The primary immunogenicity endpoints for the immunogenicity objectives are geometric mean titers (GMTs) to HPV 6, 11, 16, and 18 at Week 4 Postdose 3. The secondary endpoints are seroconversion percentages to HPV 31, 33, 45, 52 and 58 at Week 4 Postdose 3. | — |
Countries
Austria, Sweden
Outcome results
None listed