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One shot for two viruses: new combo vaccine tested in seniors

NCT ID NCT06694389

Vaccine Sponsor: ModernaTX, 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 combination vaccine called mRNA-1083 that aims to protect against both COVID-19 and the flu with a single shot. It involved 2,457 healthy adults aged 50 and older in Japan, Taiwan, and South Korea. The main goals were to check how well the vaccine triggers an immune response and to monitor any side effects.

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

2,457 people

The number who actually took part.

Started

Nov 2024

Finished

Nov 2025

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

50 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.

Key Inclusion Criteria: * Medically stable adults ≥50 years of age at the time of consent (Screening/Day 1 Visit). * A participant who could become pregnant is eligible to participate if the following is met: * Not pregnant or breast/chestfeeding, and is using a contraceptive method that is highly effective for at least 90 days after the study intervention administration and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. * Have a negative highly sensitive pregnancy test (urine) as required by local regulations at Screening/Day 1 Visit, before the study intervention. * Participants who can produce sperm are eligible to participate if they agree to the following for at least 90 days after the study intervention administration: * Refrain from donating sperm. * Either be abstinent from reproductive sexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent or must agree to use an external condom with a person who could become pregnant partner use of an additional highly effective contraceptive method with a failure rate of \<1% per year when having sexual intercourse. * Agree to use an external condom when engaging in any activity that allows for passage of ejaculate to another person. * Received ≥2 COVID-19 vaccines and the last COVID-19 vaccine was ≥150 days prior to Day 1 Key Exclusion Criteria: * History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures. * Any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results. * Known history of SARS-CoV-2 infection within 150 days prior to Day 1. * Tested positive for influenza by local health authority-approved testing methods ≤150 days prior to Day 1. * Received corticosteroids at ≥10 mg/day of prednisone or equivalent for \>14 days in total within 90 days prior to Day 1 or is anticipating the need for corticosteroids at any time during the study. Inhaled nasal and topical steroids are allowed. * Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses (for example, infliximab), within 180 days prior to Day 1 or plans to do so during the study. * Received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study injections or plans to receive a vaccine authorized or approved by a local health agency within 28 days after the study injections. * Received a seasonal influenza vaccine ≤150 days prior to Day 1. * Treated with antiviral therapies for influenza (for example, Tamiflu®) ≤150 days prior to Day 1. * Has had close contact with someone with laboratory-confirmed influenza infection or with someone who has been treated with antiviral therapies for influenza (for example, Tamiflu) within 5 days prior to Day 1 * Has had close contact to someone with COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) in the past 10 days prior to Day 1. * Has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit/Day 1 or plans to donate blood products during the study. * Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of any mRNA or influenza vaccines or any components of the mRNA or influenza vaccines, including egg protein. Note: Other protocol-defined inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

COVID-19 prevention target influenza prevention target

As listed by the trial registrant

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

COVID -19 Influenza

Contacts and locations

Locations

  • Ajou University Hospital

    Suwon, 16499, South Korea

  • Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital

    Taoyuan, 333, Taiwan

  • Chonnam National University Hospital - Allergology

    Gwangju, 61469, South Korea

  • Clinical Research Tokyo Hospital - Clinical Research Center

    Shinjuku, Tokyo, 160-0004, Japan

  • Daido Clinic

    Nagoya, Aichi-ken, 457-8511, Japan

  • Denenchofu Family Clinic

    Ōta-ku, Tokyo, 145-0071, Japan

  • Dojinkinenkai Meiwa Hospital

    Chiyoda-ku, Tokyo, 101-0041, Japan

  • Fukuoka Heartnet Hospital

    Fukuoka, Fukuoka, 819-0002, Japan

  • Hallym University Kangnam Sacred Heart Hospital

    Seoul, 07441, South Korea

  • Higashi-Shinjuku Clinic - Internal Medicine

    Shinjuku, Tokyo, 169-0072, Japan

  • Hillside Clinic Jingumae

    Shibuya-ku, Tokyo, 150-0001, Japan

  • Inha University Hospital

    Incheon, 22332, South Korea

  • Kaohsiung Medical University - Chung-Ho Memorial Hospital

    Kaohsiung City, 807, Taiwan

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 813 404, Taiwan

  • Korea University Ansan Hospital

    Ansan-si, 15355, South Korea

  • Korea University Guro Hospital

    Seoul, 08308, South Korea

  • Kuang Tien General Hospital - Dajia

    Taichung, 437, Taiwan

  • Kyungpook National University Hospital - Infectious Diseases

    Daegu, South Korea

  • Medical Coporation of Yamazaki Neurotology, Rhinolaryngology Clinical

    Sapporo, Hokkaido, 060-0011, Japan

  • Medical Corporation Asbo Tokyo Asbo Clinic

    Chuo-ku, Tokyo, 104-0031, Japan

  • Metropolitan Clinic - Internal Medicine

    Toshima-ku, Tokyo, 171-0021, Japan

  • Motomachi Takatsuka Naika Clinic - Internal Medicine

    Yokohama, Kanagawa, 231-0023, Japan

  • National Cheng Kung University Hospital

    Tainan, 704, Taiwan

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • New Medical Research System Clinic

    Hachioji-shi, Tokyo, 192-0046, Japan

  • Nihonbashi Sakura Clinic

    Chuo-ku, Tokyo, 103-0025, Japan

  • Nishi-Kumamoto Hospital

    Kumamoto, Kumamoto, 861-4157, Japan

  • PS Clinic - Internal medicine

    Fukuoka, Fukuoka, 812-0025, Japan

  • Public Health Association.Inc.

    Nagoya, Aichi-ken, 453-0804, Japan

  • Sakurajyuji Medical Corporation Medimesse Sakurajyuji Clinic

    Kumamoto, Kumamoto, 860-0833, Japan

  • Sato Hospital

    Osaki-shi, Miyagi, 989-6143, Japan

  • Seishukai Clinic

    Taito-ku, Tokyo, 111-0036, Japan

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Shimamura Memorial Hospital

    Nerima City, Tokyo, 177-0051, Japan

  • Shinei Medical Healthcare Clinic

    Suginami, Tokyo, 166-0003, Japan

  • Shinwakai Adachi Kyosai Hospital - Internal Medicine

    Adachi-ku, Tokyo, 120-0022, Japan

  • Souseikai Sumida Hospital

    Sumida-Ku, Tokyo, 130-0004, Japan

  • Taipei Medical University - Taipei Medical University Hospital

    Taipei, 110, Taiwan

  • Tenjin Sogo Clinic

    Fukuoka, Fukuoka, 810-0021, Japan

  • Tokyo center clinic - Internal medicine

    Chuo-ku, Tokyo, 103-0027, Japan

  • Tri-Service General Hospital - Neihu Branch - Infectious Diseases

    Taipei, 114, Taiwan

  • Yokoi Medicine Clinic

    Mino, Osaka, 562-0003, Japan

  • Yonsei University, Wonju Severance Christian Hospital

    Wŏnju, South Korea

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