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
Sites (30)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro de Atención e Investigación Médica SAS - CAIMED CHIA ( Site 0151) Coordinator of this site? Confirm its status | Chía | Colombia | Unknown status |
| Fundación Centro de Investigación Clínica CIC ( Site 0157) Coordinator of this site? Confirm its status | Medellín | Colombia | Unknown status |
| Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan ( Coordinator of this site? Confirm its status | Mérida | Mexico | Unknown status |
| CAIMED México ( Site 0207) Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Unidad biomedica avanzada monterrey ( Site 0203) Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| AINPAD ( Site 0204) Coordinator of this site? Confirm its status | Morelia | Mexico | Unknown status |
| Jerzy Brzostek Prywatny Gabinet Lekarski ( Site 0553) Coordinator of this site? Confirm its status | Dębica | Poland | Unknown status |
| Gravita Diagnostyka i Leczenie Nieplodnosci ( Site 0555) Coordinator of this site? Confirm its status | Lodz | Poland | Unknown status |
| ALERGO-MED Specjalistyczna Przychodnia Lekarska ( Site 0557) Coordinator of this site? Confirm its status | Tarnów | Poland | Unknown status |
| Uniwersytecki Szpital Kliniczny-Klinika Pediatrii i Chorob Infekcyjnych ( Site 0556) Coordinator of this site? Confirm its status | Wroclaw | Poland | Unknown status |
| Taichung Veterans General Hospital ( Site 0653) Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| National Taiwan University Hospital ( Site 0651) Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Chang Gung Medical Foundation.Linkou Branch ( Site 0652) Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
| MultiCare Rockwood Cheney Clinic ( Site 0038) Coordinator of this site? Confirm its status | Cheney | United States | Unknown status |
| Coastal Bend Clinical Research ( Site 0025) Coordinator of this site? Confirm its status | Corpus Christi | United States | Unknown status |
| Kaiser Permanente Daly City ( Site 0044) Coordinator of this site? Confirm its status | Daly City | United States | Unknown status |
| University of Texas Medical Branch-Sealy Institute for Vaccine Sciences Clinical Trials Program ( Si Coordinator of this site? Confirm its status | Galveston | United States | Unknown status |
| Tribe Clinical Research, LLC ( Site 0010) Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| Advanced Research for Health Improvement, LLC-Pediatrics ( Site 0007) Coordinator of this site? Confirm its status | Naples | United States | Unknown status |
| Coastal Carolina Research Center ( Site 0032) Coordinator of this site? Confirm its status | North Charleston | United States | Unknown status |
| Kaiser Permanente Oakland ( Site 0020) Coordinator of this site? Confirm its status | Oakland | United States | Unknown status |
| Kaiser Permanente Roseville ( Site 0047) Coordinator of this site? Confirm its status | Roseville | United States | Unknown status |
| Kaiser Permanente Sacramento ( Site 0043) Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Kaiser Permanente South Sacramento ( Site 0045) Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Kaiser Permanente San Jose ( Site 0046) Coordinator of this site? Confirm its status | San Jose | United States | Unknown status |
| Kaiser Permanente Santa Clara ( Site 0042) Coordinator of this site? Confirm its status | Santa Clara | United States | Unknown status |
| Encompass Clinical Research ( Site 0022) Coordinator of this site? Confirm its status | Spring Valley | United States | Unknown status |
| Desmond Tutu HIV Foundation ( Site 0355) Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| TREAD Research ( Site 0354) Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| Perinatal HIV Research Unit_Do not use - Duplicate facility ( Site 0351) Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.