Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children
第3相
完了
NCT04816643
| 対象疾患 | SARS-CoV-2 Infection, COVID-19 |
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| 相 | 第3相 |
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| スポンサー | BioNTech SE |
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| ステータス | 完了 |
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| 参加者数 | 11,837 名 |
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| 介入（薬剤） | Biological/Vaccine: BNT162b2 10mcg, BNT162b2 20mcg, BNT162b2 30mcg, Biological/Vaccine: BNT162b2 3mcg |
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| 開始日 | 2021年3月24日 |
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| 完了日 | 2023年10月4日 |
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| 結果公開日 | 2026年5月28日 |
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概要
This is a Phase 1/2/3 study in healthy children. Dependent upon safety and/or immunogenicity data generated during the course of this study, and the resulting assessment of benefit-risk, the safety, tolerability, and immunogenicity of BNT162b2 in participants \<6 months of age may subsequently be evaluated.
Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=5 to <12 Years of Age
Phase 1: From Day 1 to Day 7 after Dose 1 · Percentage of participants
| Phase 1: BNT162b2 (10 mcg): 5 to <12 Years of Age | 12.5 Percentage of participants |
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| Phase 1: BNT162b2 (20 mcg): 5 to <12 Years of Age | 0 Percentage of participants |
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| Phase 1: BNT162b2 (30/30 mcg): 5 to <12 Years of Age | 100.0 Percentage of participants |
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| Phase 1: BNT162b2 (30/10 mcg): 5 to <12 Years of Age | 16.7 Percentage of participants |
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| Phase 1: BNT162b2 (10 mcg): 5 to <12 Years of Age | 6.3 Percentage of participants |
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| Phase 1: BNT162b2 (20 mcg): 5 to <12 Years of Age | 0 Percentage of participants |
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Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: >=5 to <12 Years of Age
Phase 1: Day 1 to Day 7 after Dose 2 · Percentage of participants
| Phase 1: BNT162b2 (10 mcg): 5 to <12 Years of Age | 37.5 Percentage of participants |
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| Phase 1: BNT162b2 (20 mcg): 5 to <12 Years of Age | 18.8 Percentage of participants |
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| Phase 1: BNT162b2 (30/30 mcg): 5 to <12 Years of Age | 75.0 Percentage of participants |
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| Phase 1: BNT162b2 (30/10 mcg): 5 to <12 Years of Age | 16.7 Percentage of participants |
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| Phase 1: BNT162b2 (10 mcg): 5 to <12 Years of Age | 25.0 Percentage of participants |
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| Phase 1: BNT162b2 (20 mcg): 5 to <12 Years of Age | 6.3 Percentage of participants |
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Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: >=5 to <12 Years of Age
Phase 1: Day 1 to Day 7 after Dose 3 · Percentage of participants
| Phase 1: 5 to <12 Years BNT162b2 10 mcg | 28.9 Percentage of participants |
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| Phase 1: 5 to <12 Years BNT162b2 10 mcg | 21.1 Percentage of participants |
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| Phase 1: 5 to <12 Years BNT162b2 10 mcg | 7.9 Percentage of participants |
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| Phase 1: 5 to <12 Years BNT162b2 10 mcg | 0 Percentage of participants |
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| Phase 1: 5 to <12 Years BNT162b2 10 mcg | 0 Percentage of participants |
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| Phase 1: 5 to <12 Years BNT162b2 10 mcg | 13.2 Percentage of participants |
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