健康な成人におけるV114の安全性および免疫原性(V114-019/PNEU-AGE)
基本情報
- NCT ID
- NCT03950622
- 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
- 1,205
- 治験依頼者名
- Merck Sharp & Dohme LLC
概要
The purpose of this study is to 1) evaluate the safety and tolerability of V114 and 2) to compare the immune responses of the 15 serotypes contained in V114 with V114 versus Prevnar 13™. The primary hypotheses are that 1) V114 is noninferior to Prevnar 13™ as measured by the serotype specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) for 13 shared serotypes at 30 days postvaccination and that 2) V114 is superior to Prevnar 13™ as measured by serotype-specific OPA GMTs for 2 unique serotypes in V114 at 30 days postvaccination.
対象疾患
介入
依頼者(Sponsor)
実施施設 (5)
医療法人平心会 大阪治験病院
Osaka, Japan
P-One Clinic, Keikokai Medical Corp. ( Site 0400)
Hachiōji, Tokyo, Japan
医療法人社団鳳栄会末松整形外科医院
Tokyo, Japan
Souseikai Nishikumamoto Hospital ( Site 0404)
Kumamoto, Japan
Souseikai PS Clinic ( Site 0402)
Fukuoka, Japan