ワクチン未接種の日本人高齢者におけるV116の安全性および免疫原性（V116-009、STRIDE-9）

基本情報

NCT ID

NCT05633992

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

450

治験依頼者名

Merck Sharp & Dohme LLC

概要

This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 in pneumococcal vaccine-naïve Japanese adults 65 years of age and older. The polyvalent (23-valent) pneumococcal vaccine, PPSV23, is the active comparator. In addition to studying safety/tolerability, it is hypothesized that, at 30 days postvaccination, the immunogenicity of V116 is noninferior to PPSV23 for the 12 common serotypes in V116 and PPSV23 and the cross-reactive serotype 15B in V116, and that the immunogenicity of V116 is superior to PPSV23 for the unique serotype 15C in V116. It is also hypothesized that V116 is superior to PPSV23 in the percentage of participants with ≥4-fold rise from baseline in the 8 unique V116 serotypes (except for 15C), as measured by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs).

対象疾患

介入

依頼者（Sponsor）

実施施設 (12)