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

Publications

• Leroux-Roels I, Huang G, Ferguson M, Kohli A, Clark R, Bickel M, Soens M, Du E, Pucci A, Hicks B, Eschen C, Das R, Wilson E; Fluent Trial Investigators. Efficacy and Safety of an mRNA Seasonal Influenza Vaccine in Adults. N Engl J Med. 2026 May 7;394(18):1803-1813. doi: 10.1056/NEJMoa2516491.

Drugs

Indications