A Study of mRNA-based Influenza and SARS-CoV-2 (COVID-19) Multi-component Vaccines in Healthy Adults
1/2期
已完成
NCT05827926
| 适应症 | SARS-CoV-2, Influenza |
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| 分期 | 1/2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 | 1,758 人 |
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| 干预（药物） | Influenza Vaccine 1, mRNA-1083.1, mRNA-1083.2, mRNA-1083.3, Investigational Influenza Vaccine 1 |
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| 开始日期 | 2023年4月14日 |
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| 完成日期 | 2024年12月3日 |
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| 结果公布日 | 2025年12月23日 |
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摘要
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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在 BENITIONS 中查看
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。