A Study of mRNA-based Influenza and SARS-CoV-2 (COVID-19) Multi-component Vaccines in Healthy Adults
1/2상
완료
NCT05827926
| 대상 질환 | SARS-CoV-2, Influenza |
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| 임상 단계 | 1/2상 |
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| 스폰서 | ModernaTX, Inc. |
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| 상태 | 완료 |
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| 참여자 수 | 1,758 명 |
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| 중재(약물) | Influenza Vaccine 1, mRNA-1083.1, mRNA-1083.2, mRNA-1083.3, Investigational Influenza Vaccine 1 |
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| 시작일 | 2023년 4월 14일 |
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| 완료일 | 2024년 12월 3일 |
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| 결과 공개일 | 2025년 12월 23일 |
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요약
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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BENITIONS에서 보기
ClinicalTrials.gov 원문 보기
전체 임상
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