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Combined COVID-19/influenza vaccine shows positive results in phase 3 trial

June 12, 2024

Moderna announced that its phase 3 trial of mRNA-1083, an investigational combination vaccine against influenza and COVID-19, met its primary endpoints, eliciting higher immune responses against influenza virus and SARS-CoV-2 than licensed influenza and COVID-19 vaccines in adults 50 years and older, including an enhanced influenza vaccine in adults 65 years and older.

• The ongoing phase 3 clinical trial (ClinicalTrials.gov: NCT06097273) is a randomized, observer-blind, active control study evaluating the safety, reactogenicity and immunogenicity of mRNA-1083 in two independent age group cohorts of approximately 4,000 adults each. One cohort, consisting of adults 65 years and older, compared mRNA-1083 to co-administered Fluzone HD, an enhanced influenza vaccine, and Spikevax, Moderna's currently licensed COVID-19 vaccine. The other cohort of adults 50 to 64 years of age compared mRNA-1083 to co-administered, Fluarix, a standard dose influenza vaccine, and Spikevax.
• Immune responses from a single dose of mRNA-1083 were found to be non-inferior to the co-administered, routinely recommended, licensed comparators. In both age cohorts, mRNA-1083 also elicited statistically significantly higher immune responses against three influenza virus strains (H1N1, H3N2, and B/Victoria) and against SARS-CoV-2.
• mRNA-1083 showed an acceptable tolerability and safety profile. The majority of solicited adverse reactions were grade 1 or 2 in severity and consistent with the licensed vaccines used in the trial. The most common adverse reactions were injection site pain, fatigue, myalgia, and headache.

Source:

(2024, June 10). Moderna. Moderna Announces Positive Phase 3 Data for Combination Vaccine Against Influenza and COVID-19. [Press release]. https://investors.modernatx.com/news/news-details/2024/Moderna-Announces-Positive-Phase-3-Data-for-Combination-Vaccine-Against-Influenza-and-COVID-19-/default.aspx