NCT05450705

V503 in Chinese Girls 9-14 Years Old Versus Chinese Women 20-26 Years Old (V503-071)

A Phase 3 Open-Label Immunogenicity and Safety Study of 2-Dose Regimens of a 9vHPV Vaccine (V503) in Chinese Girls 9 Through 14 Years of Age With a Comparison to 3-Dose Regimen of V503 in Chinese Women 20 Through 26 Years of Age

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,500 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Female
• Age: 9 Years – 26 Years
• Healthy volunteers: Accepted

Summary

This study aims to demonstrate that a 2-dose regimen of the 9-Valent Human Papillomavirus (9vHPV) vaccine (GARDASIL™9, V503) induces non-inferior competitive Luminex immunoassay (cLIA) geometric mean titers (GMTs) to each of the 9vHPV vaccine types in Chinese girls 9 through 14 years of age compared to a 3-dose regimen in Chinese women 20 through 26 years of age. The primary hypothesis is that a 2-dose regimen has a non-inferiority margin of 0.67 in the GMT ratio (girls vs. women) for each HPV type.

Conditions

• Papillomavirus Infections

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: 2022-07-22
• Primary completion: 2029-08-03
• Completion: 2029-08-03
• First posted: 2022-07-11
• Last updated: 2022-09-02

Locations

2 sites across 1 country: China

Regulatory

• FDA-regulated drug study