A Study of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age

Summary

The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of mRNA-1083 as compared with active control, co-administered licensed influenza and severe acute respiratory syndrome coronavirus 2 (SARS CoV 2) vaccines, in 2 independent age-group sub-study cohorts, healthy adults 65 years and older (Cohort A) and healthy adults 50 to \<65 years of age (Cohort B).

Timeline

Start

2023-10-19

Primary completion

2024-05-28

Completion

2024-05-28

Publications

• Kostanyan L, Wu I, Sinkiewicz M, Cardona J, Johnson K, Das R. Safety and durability of influenza and SARS-CoV-2 antibody responses through 6 months after a single dose of mRNA-1083, a multicomponent influenza and COVID-19 vaccine, in adults >/=50 years. Hum Vaccin Immunother. 2026 Dec;22(1):2675021. doi: 10.1080/21645515.2026.2675021. Epub 2026 May 29.
• Rudman Spergel AK, Wu I, Deng W, Cardona J, Johnson K, Espinosa-Fernandez I, Sinkiewicz M, Urdaneta V, Carmona L, Schaefers K, Girard B, Paila YD, Mehta D, Callendret B, Kostanyan L, Ananworanich J, Miller J, Das R, Shaw CA. Immunogenicity and Safety of Influenza and COVID-19 Multicomponent Vaccine in Adults >/=50 Years: A Randomized Clinical Trial. JAMA. 2025 Jun 10;333(22):1977-1987. doi: 10.1001/jama.2025.5646.
• Sanchez-Martinez ZV, Alpuche-Lazcano SP, Stuible M, Akache B, Renner TM, Deschatelets L, Dudani R, Harrison BA, McCluskie MJ, Hrapovic S, Blouin J, Wang X, Schuller M, Cui K, Cho JY, Durocher Y. SARS-CoV-2 spike-based virus-like particles incorporate influenza H1/N1 antigens and induce dual immunity in mice. Vaccine. 2024 Dec 2;42(26):126463. doi: 10.1016/j.vaccine.2024.126463. Epub 2024 Oct 30.

Drugs

Indications