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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

Pneumococcal Infections

介入

V114(BIOLOGICAL)
Prevnar 13®(BIOLOGICAL)

依頼者(Sponsor)

MSD株式会社(INDUSTRY)

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