NCT05314023

Immunogenicity and Safety of V503 in Chinese Males 9 Through 19 Years Old (V503-053)

A Phase 3 Open-Label Immunogenicity and Safety Study of 2-Dose Regimens of V503, a 9-Valent Human Papillomavirus (HPV) Vaccine in Chinese Males 9 Through 14 Years Old and 3-Dose Regimen of V503 in Chinese Males 9 Through 19 Years Old

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,590 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Male
• Age: 9 Years – 19 Years
• Healthy volunteers: Accepted

Summary

This study is designed to demonstrate non-inferior immunogenicity of 3 doses of the 9-Valent Human Papillomavirus (9vHPV) vaccine (GARDASIL™9, V503) in Chinese males 9 through 19 years of age, and 2 doses of the 9vHPV vaccine in Chinese males 9 through 14 years of age, compared to the 3 dose regimen in Chinese males 20 through 26 years of age (from Merck Protocol V503-052). The primary hypothesis is that each of the 3-dose regimen in Chinese males aged 9 through 19 years and 2-dose regimens in Chinese males aged 9 through 14 years induces non-inferior competitive Luminex immunoassay (cLIA) geometric mean titers (GMTs) at one month post last dose compared to the 3-dose regimen in Chinese adult males aged 20 through 26 years. A noninferiority margin of 0.67 in the GMT ratio (9 through 19 years of age or 9 through 14 years of age vs 20 through 26 years of age) is used for each HPV type.

Conditions

• Genital Warts

Interventions

Type	Name	Description
BIOLOGICAL	9vHPV vaccine	A 9-valent HPV vaccine (Types 6, 11, 16, 18, 31, 33, 45, 52, and 58) will be administered as a 0.5 mL IM injection.

Timeline

• Start date: 2022-05-07
• Primary completion: 2029-02-19
• Completion: 2029-02-19
• First posted: 2022-04-06
• Last updated: 2023-01-19

Locations

5 sites across 1 country: China

Regulatory

• FDA-regulated drug study