A Study to Investigate the Safety and Immunogenicity of the Quadrivalent Influenza mRNA Vaccines in Adults Aged 18 Years and Above
1/2期
已完成
NCT06361875
| 适应症 | Influenza Immunization, Healthy Volunteers |
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| 分期 | 1/2期 |
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| 申办方 | Sanofi Pasteur, a Sanofi Company |
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| 状态 | 已完成 |
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| 受试者人数 | 908 人 |
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| 干预（药物） | 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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| 开始日期 | 2024年4月1日 |
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| 完成日期 | 2025年6月9日 |
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| 结果公布日 | 2026年8月4日 |
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摘要
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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本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。