20～45歳の男性における9価ヒトパピローマウイルスワクチン（9vHPV）の経口持続感染に対する有効性、免疫原性および安全性（V503-049）

基本情報

NCT ID

NCT04199689

ステータス

実施中（募集終了）

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

6,033

治験依頼者名

Merck Sharp & Dohme LLC

概要

The purpose of this study is to evaluate the efficacy, immunogenicity and safety of the 9vHPV vaccine in men 20 to 45 years of age. The primary hypothesis tested after the primary database lock is that administration of a 3-dose regimen of 9vHPV vaccine will reduce the incidence of human papillomavirus (HPV) 16/18/31/33/45/52/58-related oral persistent infection (6 months or longer) compared with placebo. There will also be an Extension Study to offer an opportunity to complete the 3 dose regimen of 9vHPV vaccine for participants who received placebo in the Base Study, or received less than 3 doses of 9vHPV vaccine in the Base Study.

対象疾患

介入

依頼者（Sponsor）

実施施設 (14)