Safety and Immunogenicity of Extended 2-dose Regimens of 9-valent Human Papillomavirus (9vHPV) Vaccine (V503-069)
Running, not enrolling · Phase 3
Conditions studied: Papillomavirus Infections
In brief
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).
Key facts
- Study ID
- NCT04708041
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 700
- Starts
- 2021-03-15
- Expected to finish
- 2029-10-23
- Last updated by the study team
- 2025-04-20
Who can join
Age: 9 and older, up to 26. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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:
- Has never had a Papanicolaou (Pap) test or only had normal Pap test results
- A lifetime history of 0 to 4 male and/or female sexual partners
- 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
You may not qualify if…
- All Participants:
- Known allergy to any vaccine component
- History of severe allergic reaction that required medical intervention
- Thrombocytopenia or any coagulation disorder
- Females only: participant is pregnant or expecting to donate eggs during day 1 through month 7
- Currently immunocompromised, or been diagnosed with immunodeficiency
- Had a splenectomy
- Receiving or has received immunosuppressive therapies within the last year
- Received any immunoglobulin product or blood-derived product within 3 months
- Has received more than 1 dose of an HPV vaccine (Cohort 0)
- Received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial (Cohorts 1-5)
Where it is running
- 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
Full record on ClinicalTrials.gov
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