Effectiveness of mCOMBRIAX vaccine compared with high‑dose influenza vaccine and mRNA‑1273 in adults ≥65 years for prevention of influenza and COVID‑19

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What is this study about?

The trial focuses on two common viral illnesses that affect older adults: Influenza infection and SARS‑CoV‑2 infection. It evaluates a new vaccine called mCombriax, which combines protection against both flu and COVID‑19 in a single injection. The vaccine uses messenger RNA (mRNA) to teach the body to recognize pieces of the flu viruses and the spike protein of the coronavirus. The study compares this combined vaccine with the usual practice of giving a high‑dose flu shot (Efluelda) and a COVID‑19 shot (Spikevax) at the same visit.

The purpose of the study is to determine whether the combined vaccine prevents doctor visits or hospital stays caused by flu or COVID‑19 as well as, or better than, the two separate shots. Participants aged 65 years or older will receive either the combined vaccine or the two separate vaccines on the same day and will be observed for several months. Any illness that leads to a medical appointment, emergency care, or hospitalization will be recorded to assess the vaccine’s effectiveness.

1 randomization and assignment

after joining the trial you will be placed into one of two groups by a random process. one group receives the test vaccine mcombrax, the other group receives two standard vaccines given on the same day.

2 vaccine administration

if you are assigned to the test group, a single intramuscular injection of mcombrax will be given. the injection contains a dose of 1 mg (milligram) of the vaccine formulation.

if you are assigned to the comparator group, you will receive two intramuscular injections on the same visit: one injection of efluelda (influenza vaccine) with a dose of 1 µg (microgram) and one injection of spikevax (covid‑19 vaccine) also with a dose of 1 µg. both injections are given into the muscle.

3 immediate post‑vaccination observation

after the injection(s) you will be asked to stay at the study site for about 15 to 30 minutes so that staff can watch for any immediate reactions.

4 ongoing follow‑up for health events

throughout the study period, which may last up to three years, you will continue your normal daily activities. if you experience symptoms of influenza or covid‑19, or if you need medical care or are hospitalized, you should seek care as usual and the study team will record those events.

the trial will track two main outcomes: (1) any medically attended influenza or covid‑19 infection, and (2) any influenza or covid‑19 related hospitalization.

5 final study visit

at the end of the study period, a final visit will be scheduled to complete any remaining study procedures and to close your participation.

Who Can Join the Study?

  • Age: You must be 65 years old or older at the time you receive the vaccine.
  • Language ability: You need to be able to read and understand the study information in English, or if you live in Denmark, in Danish, or if you live in Spain, in Spanish or Galician.
  • Informed consent: You must sign and date a consent form that shows you understand the study and agree to take part.

Who Cannot Join the Study?

    Where you can join this trial?

    Verified and Recommended Sites

    No sites found in this category

    Verified Sites

    No sites found in this category

    Other Sites

    Site Name City Country Status
    Ghoycmwf Hytgwbjg Hellerup Denmark
    Dclvpb Lcgbvv Vhrinfcqxhnl Sikixnv Søborg Denmark
    Uajaxfprdwnq De Szafgkdr Dj Clakylcojo Santiago De Compostela Spain

    Want to learn more about this study or check if you can participate? Contact us.

    Trial status

    Country Status Recruitment Start
    Denmark Denmark
    Not yet recruiting
    15.09.2026
    Spain Spain
    Not yet recruiting
    15.09.2026

    Trial locations

    Efluelda Tetra is a high‑dose, quadrivalent influenza vaccine given by injection into the muscle. It contains inactivated (killed) flu viruses that represent the most common strains expected each season. The vaccine works by teaching the immune system to recognize these flu viruses, helping to prevent influenza infection in older adults.

    Spikevax is a COVID‑19 mRNA vaccine (also known as Moderna’s Spikevax) administered as an intramuscular injection. It contains messenger RNA that provides the body’s cells with the instructions to make a harmless piece of the coronavirus spike protein. This triggers an immune response that protects against COVID‑19 infection.

    mCOMBRIAX is a combined vaccine that includes mRNA components for both influenza and COVID‑19. The influenza part targets the H1N1, H3N2, and B strains of flu, while the COVID‑19 part encodes key portions of the SARS‑CoV‑2 spike protein (specifically the XBB.1.5 variant). Given by injection, this single vaccine is designed to stimulate the immune system to protect against both flu and COVID‑19 in one shot.

    COVID-19 – COVID-19 is a viral infection caused by SARS‑CoV‑2 that mainly involves the respiratory system. It often starts with fever, cough, and fatigue and can spread to the lower airways. The illness may progress from mild upper‑respiratory symptoms to more extensive lung involvement, increasing breathing difficulty. Some individuals also experience muscle aches, headache, or loss of taste and smell. Symptoms usually peak within the first week and then begin to improve.

    Influenza – Influenza is an acute respiratory infection caused by influenza viruses, most frequently types A and B. It begins suddenly with fever, chills, headache, and muscle aches, followed by cough and sore throat. The virus moves through the airways and can spread from the upper to the lower respiratory tract. Symptoms typically worsen over two to three days and then gradually resolve over about a week. Occasionally, a lingering cough or fatigue may persist after the acute phase.

    Trial ID:
    2026-526720-49-00
    Protocol code:
    DAN-COMBO
    Trial Phase:
    Therapeutic confirmatory (Phase III)

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