A Study of mRNA-1018 Pandemic Influenza Candidate Vaccines in Healthy Adults

Last updated: July 14, 2025
Sponsor: ModernaTX, Inc.
Overall Status: Completed

Phase

1/2

Condition

Influenza

Treatment

mRNA-1018 for H7N9

mRNA-1018 for H5 Only-CG

mRNA-1018 for H5 Only

Clinical Study ID

NCT05972174
mRNA-1018-P101
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this Phase 1/2 study is to generate sufficient safety and immunogenicity data of mRNA-1018 pandemic influenza candidate vaccines in healthy adults ≥18 years of age to enable the initiation of a large Phase 3 trial with one selected vaccine candidate. The study will be conducted in 2 Parts (Part A and Part B) that will enroll and run concurrently. Part A of the study will evaluate 4 vaccine candidates (H5N8, H7N9, H5 only, and H7 only). Part B of the study will evaluate a single vaccine candidate (H5 only-CG).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Healthy as determined by medical evaluation including medical history, physicalexamination, laboratory tests, and results of electrocardiogram testing.

  • Body mass index of 18 kilograms (kg)/square meter (m^2) to 39 kg/m^2 (inclusive) atthe Screening visit.

  • For female participants of childbearing potential: negative pregnancy test, adequatecontraception, and not currently breastfeeding.

Exclusion

Key Exclusion Criteria:

  • Participant is acutely ill or febrile (body temperature ≥ 38.0 degrees Celsius [°C]/100.4 degrees Fahrenheit [°F]) 72 hours prior to or at the Screening Visit orDay 1.

  • History of a diagnosis or condition that, in the judgment of the Investigator, isclinically unstable or may affect participant safety, assessment of safetyendpoints, assessment of immune response, or adherence to study procedures.

  • Any medical, psychiatric, or occupational condition, including reported history ofsubstance abuse, that, in the opinion of the Investigator, might pose additionalrisk due to participation in the study or could interfere with the interpretation ofstudy results.

  • Participant has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 180 days prior to Screening Visit (for corticosteroids ≥10milligrams [mg]/day of prednisone equivalent) or is anticipating the need forimmunosuppressive treatment at any time during participation in the study.

  • Participant has received any vaccine authorized or approved by local health agencyincluding mRNA vaccine ≤28 days prior to study intervention (Day 1) or plans toreceive a vaccine authorized or approved by local health agency within 28 daysbefore or after the study intervention.

  • Participant has participated in an interventional clinical study within 28 daysprior to the Screening visit based on the medical history interview or plans to doso while participating in this study.

Other inclusion/exclusion criteria may apply.

Study Design

Total Participants: 1504
Treatment Group(s): 5
Primary Treatment: mRNA-1018 for H7N9
Phase: 1/2
Study Start date:
July 10, 2023
Estimated Completion Date:
July 16, 2024

Connect with a study center

  • Royal Victoria Infirmary

    Newcastle upon Tyne, England NE1 4LP
    United Kingdom

    Site Not Available

  • Southampton General Hospital

    Southampton, England SO16 6YD
    United Kingdom

    Site Not Available

  • University Hospitals Birmingham

    Birmingham, London B15 2TH
    United Kingdom

    Site Not Available

  • Bradford Teaching Hospitals NHS Foundation Trust

    Bradford, London BD9 6RL
    United Kingdom

    Site Not Available

  • University Hospitals

    Bristol, London Bs2 8DX
    United Kingdom

    Site Not Available

  • Cardiff and Vale University

    Cardiff, London CF14 4XW
    United Kingdom

    Site Not Available

  • Northern Care Alliance

    Salford, London M6 8HD
    United Kingdom

    Site Not Available

  • Royal Cornwall Hospital

    Truro, London TR1 3LJ
    United Kingdom

    Site Not Available

  • North Wales Clinical Research Centre

    Wrexham, London LL13 7YP
    United Kingdom

    Site Not Available

  • Quadram Institute NNUH CRF

    Norwich, Norfolk NR4 7UQ
    United Kingdom

    Site Not Available

  • Lakeside Healthcare Research Unit

    Corby, Northamptonshire NN17 2UR
    United Kingdom

    Site Not Available

  • Western Hospital Edinburgh

    Edinburgh, EH4 CXU
    United Kingdom

    Site Not Available

  • Chelsea and Westminster Hospital

    London, SW10 9NH
    United Kingdom

    Site Not Available

  • Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital

    London, SE1 7EH
    United Kingdom

    Site Not Available

  • Royal Free Hospital

    London, NW3 2QG
    United Kingdom

    Site Not Available

  • St Georges Vaccine Institute Cranmer Terrace

    London, SW17 ORE
    United Kingdom

    Site Not Available

  • University College London Hospitals NHS Foundation Trust

    London, W1T 7HA
    United Kingdom

    Site Not Available

  • Velocity Clinical Research

    North Finchley, N12 8BU
    United Kingdom

    Site Not Available

  • CenExel RCA

    Hollywood, Florida 33024
    United States

    Site Not Available

  • Velocity Clinical Research

    Savannah, Georgia 31406
    United States

    Site Not Available

  • Johnson County Clin-Trials

    Lenexa, Kansas 66219
    United States

    Site Not Available

  • DM Clinical Research

    Southfield, Michigan 48076
    United States

    Site Not Available

  • Velocity Clinical Research

    Lincoln, Nebraska 68510
    United States

    Site Not Available

  • Velocity Clinical Research Providence

    East Greenwich, Rhode Island 02818
    United States

    Site Not Available

  • DM Clinical Research

    Sugar Land, Texas 77478
    United States

    Site Not Available

  • DM Clinical Research

    Tomball, Texas 77375
    United States

    Site Not Available

  • J. Lewis Research, Inc/Jordan River Family Medicine

    South Jordan, Utah 84095
    United States

    Site Not Available

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