A Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273 Vaccine in Adolescents 12 to <18 Years Old to Prevent COVID-19
Фаза 2/3
Завершено
NCT04649151
| Заболевание | SARS-CoV-2 |
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| Фаза | Фаза 2/3 |
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| Спонсор | ModernaTX, Inc. |
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| Статус | Завершено |
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| Участники | 4,328 участн. |
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| Вмешательство | mRNA-1273, mRNA-1273.222 |
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| Дата начала | 9.12.2020 |
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| Дата завершения | 14.06.2024 |
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| Публикация результатов | 15.09.2025 |
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Кратко
The mRNA-1273 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to primarily evaluate the safety, reactogenicity, and effectiveness of mRNA-1273 vaccine administered as primary series and a booster dose (BD) to an adolescent population. The study will also evaluate the safety and immunogenicity of an mRNA-1273.222 vaccine against the SARS-CoV- 2 omicron variant as a primary series.
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
7 days post-vaccination · Participants
| Part 1A: mRNA-1273 100 μg | 586 Participants |
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| Part 1A: Placebo | 585 Participants |
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| Part 1C-1: mRNA-1273 50 µg BD | 627 Participants |
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| Part 1C-2: mRNA-1273 50 μg BD | 42 Participants |
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| Part 2: mRNA-1273 50 μg First Injection | 25 Participants |
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| Part 2: mRNA-1273 50 μg Second Injection | 18 Participants |
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Number of Participants With Unsolicited AEs
Up to 28 days post-vaccination · Participants
| Part 1A: mRNA-1273 100 μg | 582 Participants |
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| Part 1A: Placebo | 237 Participants |
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| Part 1C-1: mRNA-1273 50 µg BD | 209 Participants |
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| Part 1C-2: mRNA-1273 50 μg BD | 19 Participants |
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| Part 2: mRNA-1273 50 μg | 10 Participants |
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| Part 2: mRNA-1273 50 μg BD | 2 Participants |
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Part 1A Geometric Mean Value of Serum Pseudovirus Neutralizing Antibody (nAb) ID50 Titers From Study P203 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301
Day 57 Study P203/Day 57 Study P301 · titer
| Part 1A: mRNA-1273 100 μg | 1401.670 titer |
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| Study mRNA-1273-P301 (NCT04470427 ) mRNA-1273 100 μg | 1299.855 titer |
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| GMR | 1.078 (95% CI 0.940–1.237) |
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