日本人男性における9vHPVワクチンの有効性、免疫原性および安全性試験（V503-064）

基本情報

NCT ID

NCT04635423

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

1,059

治験依頼者名

Merck Sharp & Dohme LLC

概要

The purposes of this phase 3, double-blind, placebo-controlled clinical study are to evaluate the efficacy of V503 (9-valent human papillomavirus \[9vHPV\] vaccine) in preventing human papillomavirus (HPV)-related anogenital persistent infection, and to evaluate the safety/tolerability of V503, in Japanese males who are 16 to 26 years of age. It is hypothesized that administration of a 3-dose regimen of V503 reduces the combined incidence of HPV 6/11/16/18-related anogenital persistent infection, as well as the combined incidence of HPV 31/33/45/52/58-related anogenital persistent infection, compared with placebo. The study includes a Base Study to assess efficacy and safety of V503, and an Extension Study. Participants who received placebo in the Base Study will be eligible to receive V503 vaccine on Day 1, Month 2, and Month 6 of the Extension Study. Participants who received less than 3 doses of V503 in the Base Study will be offered the opportunity to complete the 3-dose regimen in the Extension Study.

対象疾患

介入

依頼者（Sponsor）

実施施設 (22)