A Phase 4, Pragmatic, Randomized Trial to Evaluate the Effectiveness of An Influenza/COVID-19 Vaccine (mCombriax [mRNA-1083]) in Adults ≥ 65 Years (DAN-COMBO)

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2026-526720-49-00

Enrollment

280000

Registered

2026-08-07

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS-CoV-2 infection, Influenza infection

Brief summary

The primary endpoints of the study are the occurrence of: (1) medically attended influenza and/or COVID-19; (2) influenza and/or COVID-19 hospitalization

Detailed description

Medically attended influenza, Influenza hospitalization, Medically attended COVID-19, COVID-19 hospitalization, All-cause cardio-respiratory hospitalization, All-cause hospitalization, All-cause respiratory tract disease hospitalization

Interventions

DRUGEfluelda Tetra

DRUGinjektionsvæske

DRUGsuspension i fyldt injektionssprøjte

DRUGSpikevax JN.1 50 micrograms dispersion for injection in pre-filled syringe COVID-19 mRNA Vaccine

DRUGmCOMBRIAX dispersion for injection in pre-filled syringe Influenza and COVID-19

DRUGmRNA vaccine

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoints of the study are the occurrence of: (1) medically attended influenza and/or COVID-19; (2) influenza and/or COVID-19 hospitalization	—

Secondary

Measure	Time frame
Medically attended influenza, Influenza hospitalization, Medically attended COVID-19, COVID-19 hospitalization, All-cause cardio-respiratory hospitalization, All-cause hospitalization, All-cause respiratory tract disease hospitalization	—

Outcome results

None listed

Source: EU CTIS · Data processed: Aug 8, 2026