DAN-COMBO
A Phase 4, Pragmatic, Randomized Trial to Evaluate the Effectiveness of An Influenza/COVID-19 Vaccine (mCombriax [mRNA-1083]) in Adults ≥ 65 Years
Sponsor study identifier
Secondary identifiers
CTIS
interventional
410,000
2 countries
3
Study Start
September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 21, 2026
Actual (reported)August 27, 2026
Actual (reported)September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Medically attended influenza and/or COVID-19
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.
From Day 14 after vaccination through the end of follow-up, up to 8 months after vaccination
Influenza and/or COVID-19 hospitalization
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.
From Day 14 after vaccination through the end of follow-up, up to 8 months after vaccination
An authorized mRNA-based multicomponent vaccine encoding antigens targeting both seasonal influenza and SARS-CoV-2 viruses.
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)
An authorized mRNA-based multicomponent vaccine encoding antigens targeting both seasonal influenza and SARS-CoV-2 viruses.
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)
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
Hellerup, 2900, Denmark
Danske Lægers Vaccinations Service
Søborg, 2860, Denmark
Tor Biering-Sørensen
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
First Submitted
August 21, 2026
First Posted
August 27, 2026
Study Start
September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 31, 2028
Medically attended influenza
From Day 14 after vaccination through the end of follow-up, up to 8 months after vaccination
Influenza hospitalization
From Day 14 after vaccination through the end of follow-up, up to 8 months after vaccination
Medically attended COVID-19
From Day 14 after vaccination through the end of follow-up, up to 8 months after vaccination
COVID-19 hospitalization
From Day 14 after vaccination through the end of follow-up, up to 8 months after vaccination
All-cause cardio-respiratory hospitalization
From Day 14 after vaccination through the end of follow-up, up to 8 months after vaccination
Influenza-related cardio-respiratory hospitalization
From Day 14 after vaccination through the end of follow-up, up to 8 months after vaccination
COVID-19-related cardio-respiratory hospitalization
From Day 14 after vaccination through the end of follow-up, up to 8 months after vaccination
Influenza-related respiratory tract disease hospitalization
From Day 14 after vaccination through the end of follow-up, up to 8 months after vaccination
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
General Public Health Directorate of Galician Health Service
Santiago de Compostela, A Coruña, Spain
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 27, 2026
Record last verified: 2026-08
In this trial, baseline and endpoint data will be collected from Danish administrative health registries, which are subject to Danish legislation and can only be made available to a third party under certain conditions. Please contact the sponsor-investigator in case of any inquiries.
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Source: ClinicalTrials.gov.
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