NCT04772534

Immunogenicity and Safety of the 9-valent Human Papillomavirus (9vHPV) Vaccine in Japanese Boys and Girls (V503-066)

A Phase 3, Open-label Clinical Study to Evaluate the Immunogenicity and Safety of 9vHPV Vaccine, in Japanese Boys and Girls, 9 to 15 Years of Age.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 314 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 9 Years – 15 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is the estimation of the human papillomavirus (HPV) 6, 11, 16, 18, 31, 33, 45, 52 and 58 seroconversion at 1 month post last dose (Month 7) following 3 doses and 2 doses of the 9-valent human papillomavirus (9vHPV) vaccine. No hypothesis will be tested since this study is an estimation-only study.

Conditions

• Papillomavirus Infections

Interventions

Type	Name	Description
BIOLOGICAL	9vHPV vaccine	9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection

Timeline

• Start date: 2021-05-17
• Primary completion: 2024-04-06
• Completion: 2024-04-06
• First posted: 2021-02-26
• Last updated: 2025-05-30
• Results posted: 2025-05-30

Locations

12 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study