日本人健康成人におけるメナクトラ®2回投与シリーズの免疫原性および安全性

基本情報

NCT ID

NCT02591290

ステータス

完了

試験のフェーズ

第4相

試験タイプ

介入

目標被験者数

60

治験依頼者名

Sanofi

概要

The aim of this study was to collect further information regarding an increase immune response of SP284 after an additional dose in Japanese participants. Primary Objective: * To evaluate and describe the immune responses to meningococcal antigens (serogroups A,C, Y and W-135) at 28 days following each vaccination with SP284 vaccine in participants 20 through 55 years of age. Other Pre-specified objective: * To describe the safety in terms of immediate systemic adverse events (AEs), solicited reactions, unsolicited non-serious adverse events, and serious adverse events (SAEs) following receipt of each dose of SP284 vaccine in persons 20 through 55 years of age.

対象疾患

介入

依頼者（Sponsor）