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60歳以上の日本人成人を対象とした、高用量4価インフルエンザワクチン（QIV-HD）と標準用量4価インフルエンザワクチン（QIV-SD）の免疫応答および安全性プロファイルを比較する研究
基本情報
- NCT ID
- NCT04498832
- 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
- 2,100
- 治験依頼者名
- Sanofi
概要
Primary Objective: To demonstrate that QIV-HD induced an immune response (as assessed by hemagglutination inhibition \[HAI\] geometric mean titers \[GMTs\] and seroconversion rates) that was superior to responses induced by QIV-SD for the 4 virus strains at 28 days post-vaccination in all participants. Secondary Objective: * To describe the immune response induced by QIV-HD and QIV-SD by HAI measurement method in all participants. * To describe the safety profile of all participants in each study group.
対象疾患
Influenza ImmunizationHealthy Volunteers
介入
High-Dose Quadrivalent Influenza Vaccine, (Zonal Purified, Split Virus) 2020-2021 Strains (QIV-HD)(BIOLOGICAL)
Local Standard-Dose Inactivated Quadrivalent Influenza Vaccine, 2020-2021 Strains (QIV-SD)(BIOLOGICAL)
依頼者（Sponsor）
Sanofi Pasteur, A Sanofi Company(INDUSTRY)