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

Condyloma Acuminata Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Anogenital Human Papilloma Virus Infection
• Condyloma Acuminata
• Papilloma
• Papillomavirus Infections
• Virus Diseases

• NCT number: NCT02576054
• Study type: Interventional
• Source: Merck Sharp & Dohme Corp.
• Status: Completed
• Phase: Phase 3
• Start date: November 20, 2015
• Completion date: August 8, 2018