A Study of mRNA-1010 Compared With a Licensed Influenza Vaccine in Adults ≥50 Years of Age
Summary
The primary objectives of this study are to evaluate the safety and reactogenicity of mRNA-1010, and to evaluate relative vaccine efficacy (rVE) of mRNA-1010 versus an active comparator against reverse transcription polymerase chain reaction (RT-PCR)-confirmed protocol-defined influenza-like illness (ILI) caused by any influenza A or B strains.
Timeline
- Start
- 2024-09-16
- Primary completion
- 2025-08-21
- Completion
- 2025-08-21
Outcome
Met primary endpoint
paper which corresponds to a relative vaccine efficacy of 26.6% (95% CI, 16.7 to 35.4), thereby meeting the criteria for noninferiority, superiority, and higher-level superiority. PMID 42090792 ↗
paper In this trial, mRNA-1010 was superior to standard-dose licensed vaccines for prevention of RT-PCR-confirmed, protocol-defined influenza-like illness in adults 50 years of age or older. PMID 42090792 ↗
release “mRNA-1010 achieved the most stringent superiority criterion prespecified in the protocol” q4web.com ↗
release “In a Phase 3 efficacy study (P304), mRNA-1010 achieved the most stringent superiority criterion prespecified in the protocol, with a relative vaccine efficacy (rVE) of 26.6%” q4web.com ↗
release “mRNA-1010 achieved the most stringent superiority criterion prespecified in the protocol, with an rVE of 26.6% (95% CI; 16.7%, 35.4%) in the overall study population.” q4web.com ↗
release “In a Phase 3 efficacy study (P304), mRNA-1010 achieved the most stringent superiority criterion prespecified in the protocol” q4web.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Alpharix-Tetra® | Vaccine | — | Intramuscular |
| Comparator | Fluarix | Vaccine | — | Intramuscular |
| Comparator | Fluarix Tetra | Vaccine | — | Intramuscular |
| Comparator | Influsplit Tetra™ | Vaccine | — | Intramuscular |
| Subject | mRNA-1010 | Messenger RNA (mRNA) | 37.5 ug | Intramuscular |