A Study to Evaluate a Modified RNA Vaccine Against Influenza in Adults 18 Years of Age or Older

Summary

This is a Phase 3, randomized, observer-blinded study to evaluate the efficacy, safety, tolerability, and immunogenicity of a single dose of a quadrivalent influenza modRNA vaccine compared to licensed inactivated influenza vaccine in healthy adults 18 years of age and older.

Timeline

Start

2022-09-12

Primary completion

2024-03-12

Completion

2024-03-12

Publications

• Fitz-Patrick D, McVinnie DS, Jackson LA, Crowther G, Geevarughese A, Cannon KD, Garcia LM, Pineiro Puebla Y, Yi Z, Cunliffe L, Maniar A, Zareba AM, Ianos CA, Gomme E, Koury K, Suphaphiphat Allen P, Anderson AS, Gurtman A, Lindert K; Pfizer C4781004 Trial Investigators. Efficacy, Immunogenicity, and Safety of Modified mRNA Influenza Vaccine. N Engl J Med. 2025 Nov 20;393(20):2001-2011. doi: 10.1056/NEJMoa2416779.

Drugs

Indications