A Study of mRNA-based Influenza and SARS-CoV-2 (COVID-19) Multi-component Vaccines in Healthy Adults
Фаза 1/2
Завершено
NCT05827926
| Заболевание | SARS-CoV-2, Influenza |
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| Фаза | Фаза 1/2 |
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| Спонсор | ModernaTX, Inc. |
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| Статус | Завершено |
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| Участники | 1,758 участн. |
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| Вмешательство | Influenza Vaccine 1, mRNA-1083.1, mRNA-1083.2, mRNA-1083.3, Investigational Influenza Vaccine 1 |
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| Дата начала | 14.04.2023 |
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| Дата завершения | 3.12.2024 |
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| Публикация результатов | 23.12.2025 |
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Кратко
The study is divided into 2 parts: Part 1 and Part 2. The purpose of Part 1 of this study is to generate sufficient safety, reactogenicity, and immunogenicity data to enable selection of an mRNA-1083 vaccine composition and dose level to evaluate in a subsequent Phase 3 clinical trial in adults. The purpose of Part 2 of this study is to generate safety and immunogenicity data for additional mRNA-1083 compositions and dose levels in young adults ≥18 years and \<50 years of age.
Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Up to 7 days after study injection · Participants
| Part 1 Cohort A12: Influenza Vaccine 1 | 32 Participants |
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| Part 1 Cohort A13: Influenza Vaccine 2 | 36 Participants |
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| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | 37 Participants |
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| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | 43 Participants |
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| Part 1 Cohort A10: COVID-19 Vaccine 1 | 42 Participants |
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| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | 31 Participants |
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Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs
Up to 28 days after study injection · Participants
| Part 1 Cohort A12: Influenza Vaccine 1 | 5 Participants |
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| Part 1 Cohort A13: Influenza Vaccine 2 | 9 Participants |
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| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | 7 Participants |
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| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | 5 Participants |
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| Part 1 Cohort A10: COVID-19 Vaccine 1 | 7 Participants |
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| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | 9 Participants |
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Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation
Day 1 through Day 181 · Participants
| Part 1 Cohort A12: Influenza Vaccine 1 | 2 Participants |
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| Part 1 Cohort A13: Influenza Vaccine 2 | 2 Participants |
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| Part 1 Cohort A11: Investigational Influenza Vaccine 2 | 1 Participants |
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| Part 1 Cohort A8: Investigational Influenza Vaccine 1 | 1 Participants |
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| Part 1 Cohort A10: COVID-19 Vaccine 1 | 2 Participants |
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| Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 | 1 Participants |
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