GSKの治験用RSウイルス（RSV）ワクチンの60歳以上の成人を対象とした有効性試験

基本情報

NCT ID: NCT04886596
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: 26,675
治験依頼者名: GlaxoSmithKline

概要

This study will evaluate the efficacy of the RSVPreF3 OA investigational vaccine in preventing Lower Respiratory Tract Disease (LRTD) caused by RSV in adults ≥60 years of age following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses in Northern Hemisphere (NH) and in Southern Hemisphere (SH). This study will also assess if the vaccine is safe and induces an immune response.

対象疾患

Respiratory Syncytial Virus Infections

介入

Placebo(BIOLOGICAL)

RSVPreF3 OA vaccine(BIOLOGICAL)

依頼者（Sponsor）

グラクソ・スミスクライン株式会社(INDUSTRY)

実施施設 (14)

GSK Investigational Site

Tokyo, Japan

GSK Investigational Site

Hiroshima, Japan

GSK Investigational Site

Osaka, Japan

医療法人　徳洲会　静岡徳洲会病院

Shizuoka, Japan

GSK Investigational Site

Tokyo, Japan

GSK Investigational Site

Okinawa, Japan

GSK Investigational Site

Tokyo, Japan

GSK Investigational Site

Yamaguchi, Japan

GSK Investigational Site

Chiba, Japan

GSK Investigational Site

Yamagata, Japan

GSK Investigational Site

Tokyo, Japan

GSK Investigational Site

Kumamoto, Japan

GSK Investigational Site

Ibaraki, Japan

GSK Investigational Site

Saitama, Japan