A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Vaccine Boosters
2期
已完成
NCT05137236
| 适应症 | SARS-CoV-2 |
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| 分期 | 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 | 540 人 |
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| 干预（药物） | mRNA-1283, mRNA-1283.211, mRNA-1273, mRNA-1283.529 |
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| 开始日期 | 2021年12月6日 |
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| 完成日期 | 2023年3月23日 |
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| 结果公布日 | 2025年7月17日 |
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摘要
The main goal of Part A of this study is to assess the safety, reactogenicity, and immunogenicity of the study vaccine candidates. The main goal of Part B of this study is to assess the safety, reactogenicity, and immunogenicity of the mRNA-1283.529 booster vaccine candidate.
Parts A and B: Number of Participants With Solicited Local and Solicited Systemic Reactogenicity Adverse Reactions (ARs)
Up to Day 7 · Participants
| Part A: mRNA-1283 Low Dose | 30 Participants |
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| Part A: mRNA-1283 Medium Dose | 40 Participants |
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| Part A: mRNA-1283 High Dose | 37 Participants |
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| Part A: mRNA-1283.211 Low Dose | 28 Participants |
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| Part A: mRNA-1283.211 High Dose | 29 Participants |
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| Part A: mRNA-1273 | 46 Participants |
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Parts A and B: Number of Participants With Unsolicited AEs
Up to Day 28 · Participants
| Part A: mRNA-1283 Low Dose | 13 Participants |
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| Part A: mRNA-1283 Medium Dose | 9 Participants |
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| Part A: mRNA-1283 High Dose | 11 Participants |
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| Part A: mRNA-1283.211 Low Dose | 12 Participants |
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| Part A: mRNA-1283.211 High Dose | 7 Participants |
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| Part A: mRNA-1273 | 8 Participants |
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Parts A and B: Number of Participants With Serious Adverse Events (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal From Study Participation and AEs of Special Interest (AESIs)
Day 1 to Day 366 · Participants
| Part A: mRNA-1283 Low Dose | 2 Participants |
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| Part A: mRNA-1283 Medium Dose | 1 Participants |
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| Part A: mRNA-1283 High Dose | 2 Participants |
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| Part A: mRNA-1283.211 Low Dose | 3 Participants |
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| Part A: mRNA-1283.211 High Dose | 3 Participants |
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| Part A: mRNA-1273 | 2 Participants |
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在 BENITIONS 中查看
查看 ClinicalTrials.gov 原文
全部试验
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。