A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Vaccine Boosters
2상
완료
NCT05137236
| 대상 질환 | SARS-CoV-2 |
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| 임상 단계 | 2상 |
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| 스폰서 | ModernaTX, Inc. |
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| 상태 | 완료 |
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| 참여자 수 | 540 명 |
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| 중재(약물) | mRNA-1283, mRNA-1283.211, mRNA-1273, mRNA-1283.529 |
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| 시작일 | 2021년 12월 6일 |
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| 완료일 | 2023년 3월 23일 |
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| 결과 공개일 | 2025년 7월 17일 |
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요약
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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BENITIONS에서 보기
ClinicalTrials.gov 원문 보기
전체 임상
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