NCT03158220

Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004)

An Open-Label Phase III Clinical Trial to Study the Immunogenicity and Tolerability of GARDASIL®9 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Adult Women (27- to 45-Year-Olds) Compared to Young Adult Women (16 to 26 Year Olds)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,212 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Female
• Age: 16 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study will assess the safety and immunogenicity of GARDASIL®9 (V503) in 16- to 45-year-old women. The primary hypothesis of the study states that anti-HPV 16, 18, 31, 33, 45, 52, and 58 geometric mean titers (GMTs) at 4 weeks postdose 3 are non-inferior in adult women as compared with GMTs in young adult women.

Conditions

• Cervical Cancer
• Vulvar Cancer
• Vaginal Cancer
• Genital Warts
• Human Papillomavirus Infection

Interventions

Type	Name	Description
BIOLOGICAL	V503	V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6

Timeline

• Start date: 2017-09-20
• Primary completion: 2018-11-19
• Completion: 2018-11-19
• First posted: 2017-05-18
• Last updated: 2019-11-21
• Results posted: 2019-11-21

Locations

24 sites across 6 countries: Austria, Belgium, Finland, Germany, Italy, Spain

Regulatory

• FDA-regulated drug study