A Study of mRNA-1283 Injection Compared With mRNA-1273 Injection in Participants ≥12 Years of Age to Prevent COVID-19
Phase 3
Completed
NCT05815498
| Condition | COVID-19 |
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| Phase | Phase 3 |
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| Sponsor | ModernaTX, Inc. |
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| Status | Completed |
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| Enrollment | 13,553 participants |
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| Interventions | mRNA-1283.222, mRNA-1273.222, mRNA-1283.815, mRNA-1273.815 |
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| Start date | Mar 28, 2023 |
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| Completion date | Apr 12, 2025 |
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| Results posted | May 1, 2026 |
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Summary
The purpose of this study (Part 1 and Part 2) is to evaluate the relative vaccine efficacy (rVE), safety, reactogenicity, and immunogenicity of mRNA-1283.222 versus mRNA-1273.222 (Part 1) and mRNA-1283.815 versus mRNA-1273.815 (Part 2).
Part 1: Geometric Mean (GM) of Omicron BA.4/5 at Day 29
Day 29 · AU/mL
| Part 1: mRNA-1283.222 | 2340.9 ± 2167.0 AU/mL |
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| Part 1: mRNA-1273.222 | 1753.8 ± 1618.2 AU/mL |
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| GMR | 1.335 (95% CI 1.194–1.492) |
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Part 1: Seroresponse Rate (SRR) Omicron BA.4/5 at Day 29
Day 29 · percentage of participants
| Part 1: mRNA-1283.222 | 79.9 ± 76.5 percentage of participants |
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| Part 1: mRNA-1273.222 | 65.5 ± 61.4 percentage of participants |
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| SRR Difference | 14.4 (95% CI 9.3–19.4) |
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Part 1: GM of the Ancestral Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) D614G at Day 29
Day 29 · AU/mL
| Part 1: mRNA-1283.222 | 10631.9 ± 9960.2 AU/mL |
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| Part 1: mRNA-1273.222 | 8576.5 ± 8012.5 AU/mL |
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| GMR | 1.240 (95% CI 1.128–1.362) |
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Open in BENITIONS
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