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New combo vaccine study: COVID-19 and flu shot together in one visit

NCT ID NCT06279871

Vaccine Sponsor: Arcturus Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new type of COVID-19 vaccine (ARCT-2303) in adults who had already received a COVID-19 vaccine. Some participants got the COVID-19 vaccine at the same time as the seasonal flu shot, while others got it alone. The goal was to see if the combination was safe and produced a strong immune response. About 1,500 healthy adults took part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,514 people

The number who actually took part.

Started

Mar 2024

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1, Individuals are male, female, or transgender adults ≥18 years of age. 2\. Healthy participants or participants with pre-existing stable medical conditions. 3\. Participant or legally authorized representatives must freely provide documented informed consent prior to study procedures being performed. 4\. Individuals must have been previously vaccinated with COVID-19 vaccines. 5\. Individuals of childbearing potential must be willing to adhere to contraceptive requirements. Exclusion Criteria: 1. Individuals with acute medical illness or febrile illness. 2. Individuals with a positive SARS-CoV-2 rapid antigen test at Screening. 3. Individuals with a history of COVID-19 or virologically confirmed SARS-CoV-2 infection within the past 5 months or history of COVID-19 with ongoing sequelae. 4. Individuals with a known history of severe hypersensitivity reactions, including anaphylaxis, or other significant adverse reactions to any components of mRNA vaccine, or influenza vaccine, including egg protein. 5. Individuals who have a positive pregnancy test at the Screening visit or who intend to become pregnant or breastfeed during the study. 6. Individuals with a history of myocarditis, pericarditis, myopericarditis or cardiomyopathy. 7. Individuals with a history of Guillain-Barré syndrome, encephalomyelitis, or transverse myelitis. 8. Individuals with a history of congenital or acquired immunodeficiency. 9. Individuals who have received immunomodulatory, immunostimulatory, or immunosuppressant drugs within 3 months of Screening; or individuals requiring systemic corticosteroids exceeding 10 mg/day of prednisone equivalent for ≥10 days within 30 days of Screening. 10. Individuals who have received immunoglobulins and/or any blood or blood products within the 3 months before the first vaccine administration or plan to receive such products at any time during the study. 11. Individuals with a documented history of HIV infection, or who are currently known to have active tuberculosis. 12. Individuals receiving treatment with another investigational drug, biological agent, or device. 13. Individuals who have received any investigational COVID-19 vaccines. 14. Individuals who received any influenza vaccine within 6 months prior to enrollment or plan to receive an influenza vaccine during the study period. 15. Individuals who have received any other licensed vaccines within 14 days prior to enrollment in this study or who are planning to receive any vaccine up to 14 days after the study vaccination. 16. Individuals who are investigator site staff members, employees of the Sponsor or the Clinical Research Organization directly involved in the conduct of the study, or site staff members otherwise supervised by the investigator or immediate family members of any of the previously mentioned individuals.

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Conditions

The condition(s) this trial relates to.

COVID-19 prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COVID -19

Contacts and locations

Locations

  • Australian Clinical Research Network (ACRN)

    Sydney, New South Wales, Australia

  • Austrials - St. Leonards

    Sydney, New South Wales, Australia

  • Austrials -Sunshine

    Melbourne, Victoria, Australia

  • CMAX

    Adelaide, South Australia, Australia

  • Clinitrials - Mount Site

    Perth, Western Australia, Australia

  • Clínica San Agustín

    San José, Costa Rica

  • Deposito de Medicamentos de Investigación Cousin Agustín (DEMEDICA)

    San Pedro Sula, Honduras

  • Emeritus Research Melbourne

    Melbourne, Victoria, Australia

  • Emeritus Research Sydney

    Sydney, New South Wales, Australia

  • Far Eastern University - Nicanor R. M Foundation

    Quezon City, Philippines

  • Griffith University Clinical Trials Unit

    Sydney, New South Wales, Australia

  • IICIMED

    San José, Costa Rica

  • Inversiones en Investigación Médica S.A (INVERIME)

    Tegucigalpa, Honduras

  • Northern Beaches Clinical Research - Walski

    Sydney, New South Wales, Australia

  • Nucleus Network

    Melbourne, Victoria, Australia

  • Nucleus Network Brisbane (Q-Pharm)

    Brisbane, Queensland, Australia

  • Organización y centro de investigación clínica Ochoa (OCINCO)

    Comayagua, Honduras

  • Paratus Clinical Blacktown

    Sydney, New South Wales, Australia

  • Paratus Clinical Brisbane

    Brisbane, Queensland, Australia

  • Paratus Clinical Canberra

    Canberra, Australian Capital Territory, Australia

  • Paratus Clinical Central Coast

    Central Coast, New South Wales, Australia

  • Sutherland Shire Clinical Research - Walski

    Miranda, New South Wales, Australia

  • The Peter Doherty Institute for Infection and Immunity

    Melbourne, Victoria, Australia

  • Tropical Disease Foundation - Putatan Health Center

    City of Muntinlupa, Philippines

  • USC Morayfield

    Morayfield, Queensland, Australia

  • USC Sippy Down

    Sunshine Coast, Queensland, Australia

  • USC Southbank

    Brisbane, Queensland, Australia

  • Veritus Research

    Melbourne, Victoria, Australia

  • Wollongong Clinical Research

    Wollongong, New South Wales, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.