A Study of Zika Vaccine mRNA-1893 in Adult Participants Living in Endemic and Non-Endemic Flavivirus Areas
第2相
完了
NCT04917861
| 対象疾患 | Zika Virus |
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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 | 完了 |
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| 参加者数 | 808 名 |
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| 介入（薬剤） | mRNA-1893 |
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| 開始日 | 2021年6月7日 |
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| 完了日 | 2024年7月26日 |
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| 結果公開日 | 2025年9月25日 |
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概要
This clinical study will evaluate the safety, tolerability, and reactogenicity of 2 dose levels of messenger RNA (mRNA)-1893 Zika vaccine in comparison to a placebo control in healthy participants who are flavivirus-seronegative and in participants who are flavivirus-seropositive.
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Up to 7 days post-vaccination · Participants
| Placebo | 86 Participants |
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| mRNA-1893 Low Dose (2-Dose Regimen) | 164 Participants |
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| mRNA-1893 High Dose (2-Dose Regimen) | 183 Participants |
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| mRNA-1893 High Dose (1-Dose Regimen) | 163 Participants |
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Number of Participants With Unsolicited Adverse Events (AEs)
Up to 28 days post-vaccination · Participants
| Placebo | 39 Participants |
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| mRNA-1893 Low Dose (2-Dose Regimen) | 47 Participants |
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| mRNA-1893 High Dose (2-Dose Regimen) | 52 Participants |
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| mRNA-1893 High Dose (1-Dose Regimen) | 45 Participants |
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Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs)
Day 1 through Day 196 for Main Study and Day 197 through Day 700 for Extension Period · Participants
| Main Study: Placebo | 5 Participants |
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| Main Study: mRNA-1893 Low Dose (2-Dose Regimen) | 2 Participants |
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| Main Study: mRNA-1893 High Dose (2-Dose Regimen) | 4 Participants |
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| Main Study: mRNA-1893 High Dose (1-Dose Regimen) | 7 Participants |
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| Extension Period: Placebo | 5 Participants |
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| Extension Period: mRNA-1893 Low Dose (2-Dose Regimen) | 4 Participants |
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