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Effectiveness of An Influenza/COVID-19 Vaccine (mCombriax [mRNA-1083]) in Adults ≥ 65 Years
Sponsor: Tor Biering-Sørensen
Summary
The purpose of this pragmatic randomized trials is to evaluate the comparative vaccine effectiveness (cVE) of mCombriax® (mRNA-1083) versus same day co-administration of the active comparators (i.e., high-dose influenza vaccine/Efluelda® and mRNA-1273/Spikevax®) among adults aged 65 years and older.
Official title: A Phase 4, Pragmatic, Randomized Trial to Evaluate the Effectiveness of An Influenza/COVID-19 Vaccine (mCombriax [mRNA-1083]) in Adults ≥ 65 Years
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
410000
Start Date
2026-09-01
Completion Date
2028-09-30
Last Updated
2026-08-27
Healthy Volunteers
Yes
Interventions
mCombriax® (mRNA-1083)
An authorized mRNA-based multicomponent vaccine encoding antigens targeting both seasonal influenza and SARS-CoV-2 viruses.
Efluelda® (TIV-HD) and Spikevax® (mRNA-1273)
Same-day co-administration of an authorized high-dose trivalent influenza vaccine (TIV-HD; Efluelda®) and an authorized COVID-19 mRNA vaccine (Spikevax®, mRNA-1273)
Locations (3)
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
Hellerup, Denmark
Danske Lægers Vaccinations Service
Søborg, Denmark
General Public Health Directorate of Galician Health Service
Santiago de Compostela, A Coruña, Spain