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)

2026-526720-49-00 · tracked via the Priya Life Science EU tracker

Sponsor

Gentofte Hospital, Moderna Inc.

Sponsor type

Hospital/Clinic/Other health care facility, Pharmaceutical company

Therapeutic area

Virus Diseases

Decision date

07/08/2026

Enrollment target

410000

Sites

Denmark, Spain

Condition studied

SARS-CoV-2 infection, Influenza infection

Investigational medicinal product(s)

Efluelda Tetrainjektionsvæskesuspension i fyldt injektionssprøjteSpikevax JN.1 50 micrograms dispersion for injection in pre-filled syringe COVID-19 mRNA VaccinemCOMBRIAX dispersion for injection in pre-filled syringe Influenza and COVID-19mRNA vaccine

Eligibility

Age group

65+ years

Sex

Female, Male

Primary endpoint

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

Endpoint detail

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

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2026-526720-49-00 on CTIS ↗ ← All trials in the EU