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
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
This is a 96-month safety and immunogenicity study conducted in boys and girls 9 to 14 years of age and in young women 16 to 26 years of age. From this study, the goal is to establish that the investigational extended 2-dose regimens (0, 12 months; 0, 24 months; 0, 36 months; and 0, 60 months) studied in boys and girls 9 to 14 years of age are generally safe and immunogenic, with an antibody response that is not inferior to that observed in young women 16 to 26 years of age who receive the standard 3-dose regimen of 9-valent human papillomavirus (9vHPV) vaccine at 0, 2, and 6 months (i.e., the population and dose regimen used to establish 9vHPV vaccine efficacy).
Inclusion Criteria:
Boys and Girls 9 to 15 Years:
- Must not have had coitarche and does not plan on becoming sexually active during the vaccination period
Women 16 to 26 Years:
Cohort 0 Participants:
- Received 1 dose of 9vHPV vaccine at least 1 year prior to enrollment and did not receive a second dose of any HPV vaccine
Exclusion Criteria:
All Participants:
Naples, Florida 34102, United States
Galveston, Texas 77555, United States
Chía, Cundinamarca 250001, Colombia
Mérida, Yucatán 97130, Mexico
Tarnów, Lesser Poland Voivodeship 33-100, Poland
Wroclaw, Lower Silesian Voivodeship 50-369, Poland
Dębica, Podkarpackie Voivodeship 39-200, Poland
Johannesburg, Gauteng 1864, South Africa