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NCT04708041Active, not recruitingPhase 3

Safety and Immunogenicity of Extended 2-dose Regimens of 9-valent Human Papillomavirus (9vHPV) Vaccine (V503-069)

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

Source: ClinicalTrials.gov · Last updated 20 Apr 2025

Brief summary (registry, in English)

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).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
700 (estimated)
First submitted
12 Jan 2021
Start date
15 Mar 2021
Primary completion date
23 Oct 2029
Lead sponsor
Merck Sharp & Dohme LLC
NCT number
NCT04708041
EudraCT number
2020-003736-24

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 700
  • From 15 Mar 2021 to the primary completion date, 23 Oct 2029
  • 30 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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)

Other illness

  • Known allergy to any vaccine component
  • History of severe allergic reaction that required medical intervention
  • Thrombocytopenia or any coagulation disorder

Other

  • All Participants:
  • 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

Who the study is looking for

  • 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

Age in the registry: 9 years to 26 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (30)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centro de Atención e Investigación Médica SAS - CAIMED CHIA ( Site 0151)
Coordinator of this site? Confirm its status
ChíaColombiaUnknown status
Fundación Centro de Investigación Clínica CIC ( Site 0157)
Coordinator of this site? Confirm its status
MedellínColombiaUnknown status
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan (
Coordinator of this site? Confirm its status
MéridaMexicoUnknown status
CAIMED México ( Site 0207)
Coordinator of this site? Confirm its status
Mexico CityMexicoUnknown status
Unidad biomedica avanzada monterrey ( Site 0203)
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MonterreyMexicoUnknown status
AINPAD ( Site 0204)
Coordinator of this site? Confirm its status
MoreliaMexicoUnknown status
Jerzy Brzostek Prywatny Gabinet Lekarski ( Site 0553)
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DębicaPolandUnknown status
Gravita Diagnostyka i Leczenie Nieplodnosci ( Site 0555)
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LodzPolandUnknown status
ALERGO-MED Specjalistyczna Przychodnia Lekarska ( Site 0557)
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TarnówPolandUnknown status
Uniwersytecki Szpital Kliniczny-Klinika Pediatrii i Chorob Infekcyjnych ( Site 0556)
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WroclawPolandUnknown status
Taichung Veterans General Hospital ( Site 0653)
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TaichungTaiwanUnknown status
National Taiwan University Hospital ( Site 0651)
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TaipeiTaiwanUnknown status
Chang Gung Medical Foundation.Linkou Branch ( Site 0652)
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TaoyuanTaiwanUnknown status
MultiCare Rockwood Cheney Clinic ( Site 0038)
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CheneyUnited StatesUnknown status
Coastal Bend Clinical Research ( Site 0025)
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Corpus ChristiUnited StatesUnknown status
Kaiser Permanente Daly City ( Site 0044)
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Daly CityUnited StatesUnknown status
University of Texas Medical Branch-Sealy Institute for Vaccine Sciences Clinical Trials Program ( Si
Coordinator of this site? Confirm its status
GalvestonUnited StatesUnknown status
Tribe Clinical Research, LLC ( Site 0010)
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GreenvilleUnited StatesUnknown status
Advanced Research for Health Improvement, LLC-Pediatrics ( Site 0007)
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NaplesUnited StatesUnknown status
Coastal Carolina Research Center ( Site 0032)
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North CharlestonUnited StatesUnknown status
Kaiser Permanente Oakland ( Site 0020)
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OaklandUnited StatesUnknown status
Kaiser Permanente Roseville ( Site 0047)
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RosevilleUnited StatesUnknown status
Kaiser Permanente Sacramento ( Site 0043)
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SacramentoUnited StatesUnknown status
Kaiser Permanente South Sacramento ( Site 0045)
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SacramentoUnited StatesUnknown status
Kaiser Permanente San Jose ( Site 0046)
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San JoseUnited StatesUnknown status
Kaiser Permanente Santa Clara ( Site 0042)
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Santa ClaraUnited StatesUnknown status
Encompass Clinical Research ( Site 0022)
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Spring ValleyUnited StatesUnknown status
Desmond Tutu HIV Foundation ( Site 0355)
Coordinator of this site? Confirm its status
Cape TownSouth AfricaUnknown status
TREAD Research ( Site 0354)
Coordinator of this site? Confirm its status
Cape TownSouth AfricaUnknown status
Perinatal HIV Research Unit_Do not use - Duplicate facility ( Site 0351)
Coordinator of this site? Confirm its status
JohannesburgSouth AfricaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.