Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273.214 SARS-CoV-2 (COVID-19) Vaccine in Infants
2期
提前终止
NCT05584202
| 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 | 提前终止 |
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| 受试者人数 | 68 人 |
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| 干预（药物） | mRNA-1273.214 |
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| 开始日期 | 2022年9月30日 |
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| 完成日期 | 2024年11月15日 |
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| 结果公布日 | 2025年11月26日 |
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摘要
The study evaluated the safety, tolerability, reactogenicity, and effectiveness of mRNA-1273.214 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine in infants aged 12 weeks to \< 6 months.
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) After First Injection
Day 1 up to 7 days after first vaccination (up to Day 8) · Participants
| mRNA-1273.214 5 μg First Injection (Solicited Safety Set) | 23 Participants |
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| mRNA-1273.214 10 μg First Injection (Solicited Safety Set) | 7 Participants |
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| mRNA-1273.214 5 μg First Injection (Solicited Safety Set) | 8 Participants |
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| mRNA-1273.214 10 μg First Injection (Solicited Safety Set) | 3 Participants |
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| mRNA-1273.214 5 μg First Injection (Solicited Safety Set) | 1 Participants |
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| mRNA-1273.214 10 μg First Injection (Solicited Safety Set) | 0 Participants |
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Number of Participants With Solicited Local and Systemic ARs After Second Injection
Day 57 up to 7 days after second vaccination (up to Day 64) · Participants
| mRNA-1273.214 5 μg Second Injection (Solicited Safety Set) | 18 Participants |
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| mRNA-1273.214 10 μg Second Injection (Solicited Safety Set) | 6 Participants |
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| mRNA-1273.214 5 μg Second Injection (Solicited Safety Set) | 7 Participants |
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| mRNA-1273.214 10 μg Second Injection (Solicited Safety Set) | 2 Participants |
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| mRNA-1273.214 5 μg Second Injection (Solicited Safety Set) | 1 Participants |
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| mRNA-1273.214 10 μg Second Injection (Solicited Safety Set) | 0 Participants |
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Number of Participants With Unsolicited Adverse Events (AEs) After Any Injection
Day 1 up to 28 days after any vaccination (up to Day 85) · Participants
| mRNA-1273.214 5 μg (Safety Set) | 24 Participants |
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| mRNA-1273.214 10 μg (Safety Set) | 8 Participants |
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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。