A Study of Zika Vaccine mRNA-1893 in Adult Participants Living in Endemic and Non-Endemic Flavivirus Areas
Фаза 2
Завершено
NCT04917861
| Заболевание | Zika Virus |
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| Фаза | Фаза 2 |
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| Спонсор | ModernaTX, Inc. |
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| Статус | Завершено |
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| Участники | 808 участн. |
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| Вмешательство | mRNA-1893 |
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| Дата начала | 7.06.2021 |
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| Дата завершения | 26.07.2024 |
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| Публикация результатов | 25.09.2025 |
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Кратко
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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