Study of mRNA-1010 Seasonal Influenza Vaccine in Adults
Фаза 3
Завершено
NCT05827978
| Заболевание | Seasonal Influenza |
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| Фаза | Фаза 3 |
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| Спонсор | ModernaTX, Inc. |
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| Статус | Завершено |
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| Участники | 8,411 участн. |
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| Вмешательство | mRNA-1010, Licensed Quadrivalent Inactivated Seasonal Influenza Vaccine |
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| Дата начала | 17.04.2023 |
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| Дата завершения | 24.06.2024 |
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| Публикация результатов | 10.07.2025 |
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Кратко
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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