日本人男児におけるV501の安全性および忍容性に関する研究（V501-200）

基本情報

NCT ID

NCT02576054

ステータス

完了

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

101

治験依頼者名

Merck Sharp & Dohme LLC

概要

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.

対象疾患

介入

依頼者（Sponsor）

実施施設 (1)