Study of mRNA-1010 Seasonal Influenza Vaccine in Adults
3期
已完成
NCT05827978
| 适应症 | Seasonal Influenza |
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| 分期 | 3期 |
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| 申办方 | ModernaTX, Inc. |
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| 状态 | 已完成 |
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| 受试者人数 | 8,411 人 |
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| 干预（药物） | mRNA-1010, Licensed Quadrivalent Inactivated Seasonal Influenza Vaccine |
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| 开始日期 | 2023年4月17日 |
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| 完成日期 | 2024年6月24日 |
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| 结果公布日 | 2025年7月10日 |
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摘要
This study includes 3 parts: Parts A, B, and C. The purpose of this study is to evaluate the immunogenicity and safety of mRNA-1010 seasonal influenza vaccine in adults.
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibody Levels as Measured by Hemagglutination Inhibition (HAI)
Day 29 · titer
| Part A: Fluarix QIV | 147.49 titer |
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| Part A: mRNA-1010 | 220.17 titer |
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| Part B: Fluarix QIV | 137.90 titer |
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| Part B: mRNA-1010 | 208.10 titer |
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| Part C: Fluzone HD QIV | 130.09 titer |
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| Part C: mRNA-1010 | 174.81 titer |
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Percentage of Participants Reaching Seroconversion, as Measured by HAI
Day 29 · percentage of participants
| Part A: Fluarix QIV | 34.9 percentage of participants |
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| Part A: mRNA-1010 | 50.2 percentage of participants |
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| Part B: Fluarix QIV | 45.0 percentage of participants |
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| Part B: mRNA-1010 | 64.4 percentage of participants |
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| Part C: Fluzone HD QIV | 36.3 percentage of participants |
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| Part C: mRNA-1010 | 49.7 percentage of participants |
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Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Up to 7 days after study injection · Participants
| Part A: Fluarix QIV | 682 Participants |
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| Part A: mRNA-1010 | 1060 Participants |
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| Part B: Fluarix QIV | 796 Participants |
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| Part B: mRNA-1010 | 1158 Participants |
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| Part C: Fluzone HD QIV | 734 Participants |
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| Part C: mRNA-1010 | 1131 Participants |
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查看 ClinicalTrials.gov 原文
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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。