Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273.214 SARS-CoV-2 (COVID-19) Vaccine in Infants
第2相
早期終了
NCT05584202
| 対象疾患 | SARS-CoV-2 |
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| 相 | 第2相 |
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| スポンサー | ModernaTX, Inc. |
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| ステータス | 早期終了 |
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| 参加者数 | 68 名 |
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| 介入（薬剤） | mRNA-1273.214 |
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| 開始日 | 2022年9月30日 |
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| 完了日 | 2024年11月15日 |
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| 結果公開日 | 2025年11月26日 |
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概要
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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BENITIONS で見る
ClinicalTrials.gov の原文を見る
すべての治験
このページは ClinicalTrials.gov の公開データをまとめたものです。医学的助言ではなく、投資助言でもありません。必ず専門医にご相談ください。