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)
Study 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.
Eligibility
Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
1. Age ≥65 years at the time of vaccination
2. Self-reported ability to understand written and spoken English or Danish (Denmark only) or Spanish or Galician (Spain only)
3. Informed consent form has been signed and dated
Exclusion Criteria:
* There are no specific exclusion criteria for this study
Primary outcome measure(s)
Medically attended influenza and/or COVID-19 — From Day 14 after vaccination through the end of follow-up, up to 8 months after vaccination Defined as a laboratory-confirmed positive influenza A/B test or positive SARS-CoV-2 test, regardless of healthcare setting, or influenza-related or COVID-19-related hospitalization, defined by ICD-10 codes.
Influenza and/or COVID-19 hospitalization — From Day 14 after vaccination through the end of follow-up, up to 8 months after vaccination Defined as hospitalization with a relevant ICD-10 code for influenza or COVID-19 infection or any hospitalization with a laboratory-confirmed positive influenza A/B test or SARS-CoV-2 test performed within 7 days prior to hospitalization or within 48 hours of hospital admission.
Trial sites (3)
Facility
City
Region
Status
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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