A Study to Investigate the Safety and Immunogenicity of the Quadrivalent Influenza mRNA Vaccines in Adults Aged 18 Years and Above
第1/2相
完了
NCT06361875
| 対象疾患 | Influenza Immunization, Healthy Volunteers |
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| 相 | 第1/2相 |
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| スポンサー | Sanofi Pasteur, a Sanofi Company |
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| ステータス | 完了 |
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| 参加者数 | 908 名 |
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| 介入（薬剤） | Quadrivalent Influenza mRNA Vaccine MRT5421, Quadrivalent Influenza mRNA Vaccine MRT5424, Quadrivalent Influenza mRNA Vaccine MRT5429, Quadrivalent Influenza Standard Dose Vaccine, Quadrivalent Influenza High-Dose Vaccine |
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| 開始日 | 2024年4月1日 |
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| 完了日 | 2025年6月9日 |
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| 結果公開日 | 2026年8月4日 |
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概要
The purpose of this study was to evaluate the safety and immunogenicity of a single intramuscular (IM) injection of different formulations of Quadrivalent Influenza Vaccine (QIV) messenger ribonucleic acid (mRNA) (MRT5421, MRT5424, and MRT5429) compared to an active control (QIV- standard dose (SD), QIV- high dose (HD) \[adults ≥ 65 years of age only\], or quadrivalent recombinant influenza vaccine (RIV4)) in adults 18 years of age and older.
Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) After Vaccine Administration
Within 30 minutes after vaccine administration on Day 1 · Participants
| QIV mRNA LNP 1: 30 mcg | 1 Participants |
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| QIV mRNA LNP 1: 96 mcg | 1 Participants |
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| QIV mRNA LNP 1: 132 mcg | 1 Participants |
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| QIV mRNA LNP 1: 192 mcg | 0 Participants |
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| QIV mRNA LNP 2: 96 mcg | 1 Participants |
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| QIV mRNA LNP 2: 192 mcg | 0 Participants |
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Number of Participants With Solicited Injection Site Reactions After Vaccine Administration
Within 7 days after vaccine administration on Day 1 · Participants
| QIV mRNA LNP 1: 30 mcg | 11 Participants |
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| QIV mRNA LNP 1: 96 mcg | 71 Participants |
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| QIV mRNA LNP 1: 132 mcg | 76 Participants |
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| QIV mRNA LNP 1: 192 mcg | 79 Participants |
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| QIV mRNA LNP 2: 96 mcg | 74 Participants |
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| QIV mRNA LNP 2: 192 mcg | 17 Participants |
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Number of Participants With Solicited Systemic Reactions After Vaccine Administration
Within 7 days after vaccine administration on Day 1 · Participants
| QIV mRNA LNP 1: 30 mcg | 15 Participants |
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| QIV mRNA LNP 1: 96 mcg | 58 Participants |
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| QIV mRNA LNP 1: 132 mcg | 71 Participants |
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| QIV mRNA LNP 1: 192 mcg | 73 Participants |
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| QIV mRNA LNP 2: 96 mcg | 60 Participants |
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| QIV mRNA LNP 2: 192 mcg | 18 Participants |
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BENITIONS で見る
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