🏛️ Verified NIH Record • Updated 2025-04-16

Safety and Immunogenicity of Extended 2-dose Regimens of 9-valent Human Papillomavirus (9vHPV) Vaccine (V503-069) (NCT04708041)

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

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Merck Sharp & Dohme LLC

🩺 Plain-English Summary (8th-Grade Level)

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).

Who can join: Review the eligibility criteria below.

Location: Kaiser Permanente Daly City ( Site 0044) — Daly City, California

Age range: 9 Years to 26 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (30 Sites)

Showing the first 25 of 30 sites.

  • Kaiser Permanente Daly City ( Site 0044) — Daly City, California
  • Kaiser Permanente Oakland ( Site 0020) — Oakland, California
  • Kaiser Permanente Roseville ( Site 0047) — Roseville, California
  • Kaiser Permanente Sacramento ( Site 0043) — Sacramento, California
  • Kaiser Permanente South Sacramento ( Site 0045) — Sacramento, California
  • Kaiser Permanente San Jose ( Site 0046) — San Jose, California
  • Kaiser Permanente Santa Clara ( Site 0042) — Santa Clara, California
  • Encompass Clinical Research ( Site 0022) — Spring Valley, California
  • Advanced Research for Health Improvement, LLC-Pediatrics ( Site 0007) — Naples, Florida
  • Tribe Clinical Research, LLC ( Site 0010) — Greenville, South Carolina
  • Coastal Carolina Research Center ( Site 0032) — North Charleston, South Carolina
  • Coastal Bend Clinical Research ( Site 0025) — Corpus Christi, Texas
  • University of Texas Medical Branch-Sealy Institute for Vaccine Sciences Clinical Trials Program ( Si — Galveston, Texas
  • MultiCare Rockwood Cheney Clinic ( Site 0038) — Cheney, Washington
  • Fundación Centro de Investigación Clínica CIC ( Site 0157) — Medellín, Antioquia
  • Centro de Atención e Investigación Médica SAS - CAIMED CHIA ( Site 0151) — Chía, Cundinamarca
  • CAIMED México ( Site 0207) — Mexico City, Mexico City
  • AINPAD ( Site 0204) — Morelia, Michoacán
  • Unidad biomedica avanzada monterrey ( Site 0203) — Monterrey, Nuevo León
  • Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan ( — Mérida, Yucatán
  • ALERGO-MED Specjalistyczna Przychodnia Lekarska ( Site 0557) — Tarnów, Lesser Poland Voivodeship
  • Uniwersytecki Szpital Kliniczny-Klinika Pediatrii i Chorob Infekcyjnych ( Site 0556) — Wroclaw, Lower Silesian Voivodeship
  • Jerzy Brzostek Prywatny Gabinet Lekarski ( Site 0553) — Dębica, Podkarpackie Voivodeship
  • Gravita Diagnostyka i Leczenie Nieplodnosci ( Site 0555) — Lodz, Łódź Voivodeship
  • Perinatal HIV Research Unit_Do not use - Duplicate facility ( Site 0351) — Johannesburg, Gauteng

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗