NCT02576054

Safety and Tolerability Study of V501 in Japanese Boys (V501-200)

A Phase III, Open-Label, Clinical Trial to Study the Safety and Immunogenicity of the Quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP Particle (VLP) Vaccine in 9- to 15-Year-Old Japanese Boys

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Male
• Age: 9 Years – 15 Years
• Healthy volunteers: Accepted

Summary

This is a study of V501 \[quadrivalent Human Papillomavirus (HPV) (Type 6, 11, 16 and 18) L1 virus-like particle (VLP) vaccine\] in healthy Japanese boys. This study will consist of two periods. Period I of the study is to evaluate the immunogenicity and tolerability of V501 up to Month 7. Period II of the study is to evaluate the long-term immunogenicity and safety from Month 7 to Month 30. Two analyses are planned. The first analysis will be conducted when all subjects have completed their Month 7 visit or have been discontinued before that time. The second analysis will be conducted at the end of study. The primary hypothesis tested in this study is that seroconversion rates for the vaccine HPV types will be \>90% at 4 weeks postdose 3.

Conditions

• Anogenital Human Papilloma Virus Infection
• Condyloma Acuminata

Interventions

Type	Name	Description
BIOLOGICAL	V501	Quadrivalent HPV \[Type 6, 11, 16 and 18\] L1 VLP vaccine), 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6

Timeline

• Start date: 2015-11-20
• Primary completion: 2018-08-08
• Completion: 2018-08-08
• First posted: 2015-10-15
• Last updated: 2019-11-25
• Results posted: 2019-09-06

Locations

1 site across 1 country: Japan