16歳から40歳までの健康な被験者を対象とした、mRNA-1647サイトメガロウイルス（CMV）ワクチンの有効性、安全性、免疫原性を評価する研究

基本情報

NCT ID

NCT05085366

ステータス

中止

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

7,454

治験依頼者名

ModernaTX, Inc.

概要

The main purpose of this study is to evaluate the efficacy of mRNA 1647 vaccine in CMV-seronegative female participants and to evaluate the safety and reactogenicity of mRNA-1647 vaccine in all participants. The purpose of the Phase 3 extension substudy is to extend the observation period of the main study and to assess the longer-term immunogenicity, efficacy, and safety of the mRNA-1647 vaccine against primary CMV infection in healthy females who were CMV-seronegative at Baseline of the mRNA-1647-P301 main study (including participants who remain CMV-seronegative upon entry into the extension substudy and participants who seroconverted during the main study). The extension substudy will also evaluate the immune persistence and safety of mRNA-1647 in a subset of female participants who were CMV-seropositive at Baseline of the main study. No interventional vaccine will be administered in the extension substudy.

対象疾患

介入

依頼者（Sponsor）

実施施設 (1)