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Safety and Immunogenicity of Extended 2-dose Regimens of 9-valent Human Papillomavirus (9vHPV) Vaccine (V503-069)
Sponsor: Merck Sharp & Dohme LLC
Summary
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).
Official title: 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
Key Details
Gender
All
Age Range
9 Years - 26 Years
Study Type
INTERVENTIONAL
Enrollment
700
Start Date
2021-03-15
Completion Date
2029-10-23
Last Updated
2025-04-20
Healthy Volunteers
Yes
Conditions
Interventions
9vHPV vaccine
9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
Locations (30)
Kaiser Permanente Daly City ( Site 0044)
Daly City, California, United States
Kaiser Permanente Oakland ( Site 0020)
Oakland, California, United States
Kaiser Permanente Roseville ( Site 0047)
Roseville, California, United States
Kaiser Permanente Sacramento ( Site 0043)
Sacramento, California, United States
Kaiser Permanente South Sacramento ( Site 0045)
Sacramento, California, United States
Kaiser Permanente San Jose ( Site 0046)
San Jose, California, United States
Kaiser Permanente Santa Clara ( Site 0042)
Santa Clara, California, United States
Encompass Clinical Research ( Site 0022)
Spring Valley, California, United States
Advanced Research for Health Improvement, LLC-Pediatrics ( Site 0007)
Naples, Florida, United States
Tribe Clinical Research, LLC ( Site 0010)
Greenville, South Carolina, United States
Coastal Carolina Research Center ( Site 0032)
North Charleston, South Carolina, United States
Coastal Bend Clinical Research ( Site 0025)
Corpus Christi, Texas, United States
University of Texas Medical Branch-Sealy Institute for Vaccine Sciences Clinical Trials Program ( Si
Galveston, Texas, United States
MultiCare Rockwood Cheney Clinic ( Site 0038)
Cheney, Washington, United States
Fundación Centro de Investigación Clínica CIC ( Site 0157)
Medellín, Antioquia, Colombia
Centro de Atención e Investigación Médica SAS - CAIMED CHIA ( Site 0151)
Chía, Cundinamarca, Colombia
CAIMED México ( Site 0207)
Mexico City, Mexico City, Mexico
AINPAD ( Site 0204)
Morelia, Michoacán, Mexico
Unidad biomedica avanzada monterrey ( Site 0203)
Monterrey, Nuevo León, Mexico
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan (
Mérida, Yucatán, Mexico
ALERGO-MED Specjalistyczna Przychodnia Lekarska ( Site 0557)
Tarnów, Lesser Poland Voivodeship, Poland
Uniwersytecki Szpital Kliniczny-Klinika Pediatrii i Chorob Infekcyjnych ( Site 0556)
Wroclaw, Lower Silesian Voivodeship, Poland
Jerzy Brzostek Prywatny Gabinet Lekarski ( Site 0553)
Dębica, Podkarpackie Voivodeship, Poland
Gravita Diagnostyka i Leczenie Nieplodnosci ( Site 0555)
Lodz, Łódź Voivodeship, Poland
Perinatal HIV Research Unit_Do not use - Duplicate facility ( Site 0351)
Johannesburg, Gauteng, South Africa
TREAD Research ( Site 0354)
Cape Town, Western Cape, South Africa
Desmond Tutu HIV Foundation ( Site 0355)
Cape Town, Western Cape, South Africa
Taichung Veterans General Hospital ( Site 0653)
Taichung, Taiwan
National Taiwan University Hospital ( Site 0651)
Taipei, Taiwan
Chang Gung Medical Foundation.Linkou Branch ( Site 0652)
Taoyuan District, Taiwan