Trials / Completed
CompletedNCT06602024
A Study of mRNA-1010 Compared With a Licensed Influenza Vaccine in Adults ≥50 Years of Age
A Phase 3, Randomized, Observer-blind, Active-controlled, Case-driven Study to Investigate the Safety, Efficacy, and Immunogenicity of mRNA-1010 Candidate Seasonal Influenza Vaccine Compared With a Licensed Inactivated Seasonal Influenza Vaccine in Adults ≥50 Years of Age
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 40,817 (actual)
- Sponsor
- ModernaTX, Inc. · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | mRNA-1010 | Intramuscular (IM) injection |
| BIOLOGICAL | Fluarix® | IM injection |
| BIOLOGICAL | Influsplit® Tetra | IM injection |
| BIOLOGICAL | Fluarix Tetra | IM injection |
| BIOLOGICAL | Alpharix® Tetra | IM injection |
Timeline
- Start date
- 2024-09-16
- Primary completion
- 2025-08-21
- Completion
- 2025-08-21
- First posted
- 2024-09-19
- Last updated
- 2025-09-10
Locations
301 sites across 11 countries: United States, Belgium, Bulgaria, Canada, Estonia, Finland, Georgia, Germany, South Korea, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06602024. Inclusion in this directory is not an endorsement.