A Study of mRNA-1010 Compared With a Licensed Influenza Vaccine in Adults ≥50 Years of Age

September 8, 2025 updated by: ModernaTX, Inc.

A Phase 3, Randomized, Observer-blind, Active-controlled, Case-driven Study to Investigate the Safety, Efficacy, and Immunogenicity of mRNA-1010 Candidate Seasonal Influenza Vaccine Compared With a Licensed Inactivated Seasonal Influenza Vaccine in Adults ≥50 Years of Age

The primary objectives of this study are to evaluate the safety and reactogenicity of mRNA-1010, and to evaluate relative vaccine efficacy (rVE) of mRNA-1010 versus an active comparator against reverse transcription polymerase chain reaction (RT-PCR)-confirmed protocol-defined influenza-like illness (ILI) caused by any influenza A or B strains.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40817

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Alken, Belgium, 3570
        • Anima Research Center
      • Ghent, Belgium, 10 - 9000
        • Universitair Ziekenhuis Gent
      • Mechelen, Belgium, 435 2800
        • Az Sint Maarten
      • Wilrijk, Belgium, 663 2650
        • University of Antwerpen - Vaccinopolis
  • Bulgaria
      • Burgas, Bulgaria
        • Medical center "Dr. Staykov" Ltd.
      • Kozloduy, Bulgaria
        • MHAT "Sveti Ivan Rilski"
      • Lovech, Bulgaria
        • Medical Center Medconsult Pleven, Lovech branch
      • Montana, Bulgaria
        • Medical Center Hera - Montana branch
      • Montana, Bulgaria
        • MHAT "Dr. Stamen Iliev"
      • Pleven, Bulgaria
        • Medical Center Medconsult Pleven
      • Plovdiv, Bulgaria
        • AIPPMP Dr. Levena Kireva
      • Plovdiv, Bulgaria
        • MHAT "Sv. Panteleymon" Ltd.
      • Sliven, Bulgaria
        • DCC-1 Sliven Lts.
      • Sliven, Bulgaria
        • MHAT Sliven to MMA Sofia
      • Sofia, Bulgaria
        • Diagnostic & Consultancy Center Ascendent, Sofia
      • Sofia, Bulgaria
        • Medical Center "Hera" EOOD
      • Sofia, Bulgaria
        • Medical Center Excelsior - Base 2
      • Sofia, Bulgaria
        • Medical Center Excelsior OOD, Base1
      • Sofia, Bulgaria
        • Medical Centre "Sirtuin" Ltd
      • Stamboliyski, Bulgaria
        • AIPPMP D-r Zhaneta Demireva Ltd.
  • Canada
      • Burlington, Canada
        • Aviva Medical Diagnostics and Specialists Clinic and Heart & Vascular Centre
      • Calgary, Canada
        • CARe Clinic, Calgary, AB
      • London, Canada
        • Milestone Research Inc.
      • Lévis, Canada
        • Centricity Research Quebec City
      • Ottawa, Canada
        • Red Maple Trials
      • Pointe-Claire, Canada
        • Centricity Research Pointe-Claire
      • Québec, Canada
        • Clinique de Lebourgneuf
      • Red Deer, Canada
        • CARe , Red Deer, AB.
      • Sarnia, Canada
        • Bluewater Clinical Research Group Inc.
      • Stouffville, Canada
        • Stouffville Medical Research Institute
      • Toronto, Canada
        • Canadian Phase Onward Inc.
      • Toronto, Canada
        • Centricity Research Toronto LMC
      • Trois-Rivières, Canada
        • Diex Recherche
      • Truro, Canada
        • Colchester Research Group
      • Victoriaville, Canada
        • Diex Recherche Victoriaville
  • Estonia
      • Paide, Estonia, 6
        • Vee Family Doctors' Center
      • Tallinn, Estonia, 4
        • Center of Clinical and Basic Research
      • Tallinn, Estonia, 68A
        • Merelahe Family Doctors Centre
      • Tallinn, Estonia, 7
        • Innomedica OÜ
      • Tartu, Estonia, 54
        • Clinical Research Center
  • Finland
      • Espoo, Finland
        • FVR - Finnish Vaccine Research Ltd - Espoo
      • Kokkola, Finland
        • FVR - Finnish Vaccine Research Ltd - Kokkola
      • Oulu, Finland
        • FVR - Finnish Vaccine Research Ltd - Oulu
      • Tampere, Finland
        • FVR - Finnish Vaccine Research Ltd - Tampere
      • Turku, Finland
        • FVR - Finnish Vaccine Research Ltd - Järvenpää
  • Georgia
      • Batumi, Georgia
        • Unimed Adjara Ltd - Batumi Referral Hospital
      • Kutaisi, Georgia
        • LTD "Hospital service"
      • Rustavi, Georgia
        • LTD Clinic Rustavi
      • Tbilisi, Georgia
        • Emergency Cardiology Center named by acad. G. Chapidze
      • Tbilisi, Georgia
        • Eristavi National Center of Experimental and Clinical Surgery
      • Tbilisi, Georgia
        • LTD Israel-Georgian Medical Research Clinic Helsicore
  • Germany
      • Berlin, Germany
        • emovis GmbH
      • Berlin, Germany
        • Klinische Forschung Berlin-Mitte GmbH
      • Berlin, Germany
        • Velocity Clinical Research Berlin, GmbH
      • Bochum, Germany
        • Praxis Rinke
      • Dresden, Germany
        • Klinische Forschung Dresden GmbH
      • Essen, Germany
        • Medizentrum Essen Borbeck
      • Frankfurt, Germany
        • IKF Pneumologie
      • Frankfurt, Germany
        • Infektio Research GmbH & Co.KG
      • Hamburg, Germany
        • Klinische Forschung Hamburg GmbH
      • Hamburg, Germany
        • Velocity Clincial Research Hamburg GmbH
      • Hanover, Germany
        • Klinische Forschung Hannover Mitte GmbH
      • Karlsruhe, Germany
        • Klinische Forschung Karlsruhe
      • Magdeburg, Germany
        • SMO.MD
      • Mainz, Germany
        • Dermatologie Quist BAG Dres. Med. Quist Part G
      • München, Germany
        • CDG Studienambulanz
      • Offenbach, Germany
        • Future meds Offenbach
      • Oldenburg, Germany
        • Red-Institut
      • Schwerin, Germany
        • Klinische forschung Schwerin GmbH
      • Stuhr, Germany
        • Studienzentrum Brinkum
      • Stuttgart, Germany
        • Hautarztpraxis Leitz & Kollegen
      • Wiesbaden, Germany
        • Velocity Clinical Research Wiesbaden
  • South Korea
      • Ansan-si, South Korea
        • Korea University Ansan Hospital
      • Bucheon-si, South Korea
        • Soon Chun Hyang University Hospital Bucheon
      • Daejeon, South Korea
        • Chungnam National University Hospital
      • Incheon, South Korea
        • Inha University Hospital
      • Seoul, South Korea
        • Seoul National University Hospital
      • Seoul, South Korea
        • Severance Hospital, Yonsei University Health System
      • Seoul, South Korea
        • Hallym University Kangnam Sacred Heart Hospital
      • Suwon, South Korea
        • Ajou University Hospital
      • Wŏnju, South Korea
        • Yonsei University, Wonju Severance Christian Hospital
  • Taiwan
      • Kaohsuing City, Taiwan
        • Kaohsiung Veterans General Hospital
      • Taichung, Taiwan
        • China Medical University Hospital
      • Taipei, Taiwan
        • National Taiwan University Hospital
      • Taoyuan, Taiwan
        • Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital
  • United Kingdom
      • Acomb, York, United Kingdom
        • Panthera Biopartners site - York
      • Birmingham, United Kingdom
        • University Hospitals Birmingham NHS Foundation Trust
      • Birmingham, United Kingdom
        • FutureMeds Birmingham
      • Blackpool, United Kingdom
        • Layton Medical Centre
      • Corby, United Kingdom
        • Lakeside Healthcare
      • Edinburgh, United Kingdom
        • NHS Lothian - Western General Hospital
      • Enfield, United Kingdom
        • Panthera Biopartners site - Enfield
      • Exeter, United Kingdom
        • Royal Devon University Healthcare NHS Foundation Trust
      • Glasgow, United Kingdom
        • Futuremeds - Glasgow
      • Glasgow, United Kingdom
        • Glasgow Panthera Biopartners Site
      • London, United Kingdom
        • Chelsea and Westminster Hospital NHS Foundation Trust
      • London, United Kingdom
        • Guy's and St Thomas's NHS Foundation Trust
      • London, United Kingdom
        • Barts Health NHS Trust - Mile End Hospital
      • London, United Kingdom
        • HMC Research Group
      • London, United Kingdom
        • St George's University Hospitals (NHS Foundation Trust)
      • London, United Kingdom
        • Velocity Clinical Research - North London
      • Manchester, United Kingdom
        • Manchester University NHS Foundation Trust
      • Metropolitan Borough of Wirral, United Kingdom
        • FutureMeds Wirral
      • Newcastle upon Tyne, United Kingdom
        • Infectious Diseases Research - Clinical Research Facility
      • Norwich, United Kingdom
        • Norfolk nand Norwich University Hospital
      • Nottingham, United Kingdom
        • University of Nottingham Health Service
      • Peterborough, United Kingdom
        • Wansford Research Limited
      • Plymouth, United Kingdom
        • University Hospitals Plymouth NHS trust
      • Portsmouth, United Kingdom
        • Portsmouth Hospitals University NHS Trust - Portsmouth Research Hub
      • Rochdale, United Kingdom
        • Panthera Biopartners - Manchester
      • Sheffield, United Kingdom
        • Sheffield Panthera Biopartners Site
      • Southampton, United Kingdom
        • Southampton General Hospital
      • Stockton-on-Tees, United Kingdom
        • Future Meds - Teesside
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Pinnacle Research Group, LLC
      • Athens, Alabama, United States, 35611
        • North Alabama Research Center, LLC
      • Birmingham, Alabama, United States, 35209
        • Flourish Research
      • Birmingham, Alabama, United States, 35210
        • EmVenio Research Brimingham, AL
      • Cullman, Alabama, United States, 35055
        • Cullman Clinical Trials
      • Huntsville, Alabama, United States, 35802
        • Optimal Research
      • Mobile, Alabama, United States, 36608
        • Velocity Clinical Research
    • Arizona
      • Glendale, Arizona, United States, 85308
        • Lenzmeier Family Medicine
      • Phoenix, Arizona, United States, 85012
        • DM Clinical Research
      • Phoenix, Arizona, United States, 85028
        • Helios Clinical Research
      • Tempe, Arizona, United States, 85283
        • Fiel Family and Sports Medicine
      • Tucson, Arizona, United States, 85711
        • Arizona Liver Health
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Baptist Health Center for Clinical Research
      • Rogers, Arkansas, United States, 72758
        • Woodland Research
    • California
      • Colton, California, United States, 92324
        • Benchmark Research - Colton
      • Covina, California, United States, 91723
        • Flourish Research
      • Huntington Park, California, United States, 90255
        • Velocity Clinical Research - Huntington Park
      • La Mesa, California, United States, 91942
        • Velocity Clinical Research, San Diego
      • Long Beach, California, United States, 90805
        • Long Beach Research Institute LLC
      • Los Angeles, California, United States, 90057
        • Velocity Clinical Research - Westlake
      • Newport Beach, California, United States, 92660
        • M3 Wake Research/PRI, LLC
      • North Hollywood, California, United States, 91606
        • Carbon Health North Hollywood
      • Northridge, California, United States, 91325
        • Valley Clinical Trials, Inc.
      • Redding, California, United States, 96001
        • Paradigm Research
      • Riverside, California, United States, 92503
        • Artemis Institute for Clinical Research
      • Rolling Hills Estates, California, United States, 90274
        • Peninsula Research Associates (PRA)
      • San Bernardino, California, United States, 92408
        • Velocity Clinical Research - Banning
      • San Diego, California, United States, 92120
        • Wr-McCr, Llc
      • San Diego, California, United States, 92103
        • Artemis Institute for Clinical Research - Research Site
      • San Diego, California, United States, 92111
        • WHCR- M3 Wake Research
      • Santa Ana, California, United States, 92704
        • Velocity Clinical Research
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research
    • Colorado
      • Fort Collins, Colorado, United States, 80525
        • Tekton Research - Fort Collins
      • Longmont, Colorado, United States, 80501
        • Tekton Research, Inc - Longmont Center
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • Stamford Therapeutics Consortium
      • Waterbury, Connecticut, United States, 06708
        • Chase Medical Research, LLC
    • Florida
      • Atlantis, Florida, United States, 33462
        • JEM Research Institue
      • Crystal River, Florida, United States, 34429
        • Nature Coast Clinical Research, LLC - Crystal River
      • Hialeah, Florida, United States, 33016
        • Homestead Associates in Research,Inc
      • Hollywood, Florida, United States, 33024
        • Cenexel RCA
      • Inverness, Florida, United States, 34452
        • Nature Coast Clinical Research, LLC - Inverness
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
      • Jacksonville, Florida, United States, 32205-4785
        • Westside Center For Clinical Research
      • Jupiter, Florida, United States, 33458
        • Health Awareness Inc
      • Lake City, Florida, United States, 32055
        • M3 Wake Research/MSRA,LLC
      • Lake Mary, Florida, United States, 32746
        • Accel Clinical Research
      • Leesburg, Florida, United States, 34748
        • Clinical Site Partners - Leesburg
      • Maitland, Florida, United States, 32751
        • K2 Medical Research
      • Maitland, Florida, United States, 32751
        • ARS - Meridien Research
      • Miami, Florida, United States, 33155
        • Miami Clinical Research
      • Miami, Florida, United States, 33173
        • Suncoast Research Associates, LLC
      • Miami, Florida, United States, 33135
        • South Florida Research Center, Inc.
      • Miami Lakes, Florida, United States, 33016
        • Floridian Clinical Research
      • Orlando, Florida, United States, 32819
        • Headlands Research
      • Pembroke Pines, Florida, United States, 33024
        • Suncoast Research Associates
      • Port Saint Lucie, Florida, United States, 34952
        • Health Awareness Inc
      • St. Petersburg, Florida, United States, 33704
        • IMA Clinical Research Warren
      • Tampa, Florida, United States, 33613
        • Forward Clinical Trials - Dermatology
      • Winter Park, Florida, United States, 32789
        • Clinical Site Partners, LLC
    • Georgia
      • Albany, Georgia, United States, 31707
        • Javara
      • Columbus, Georgia, United States, 31904
        • IACT Health
      • Decatur, Georgia, United States, 30030
        • CenExel iResearch , LLC
      • Savannah, Georgia, United States, 31405
        • CenExel iResearch Savannah
      • Savannah, Georgia, United States, 31406-2675
        • Velocity Clinical Research-Savannah
      • Savannah, Georgia, United States, 31406
        • Javara - Privia Medical Group Georgia, LLC
      • Stockbridge, Georgia, United States, 30281
        • Clinical Research Atlanta/Headlands
    • Hawaii
      • Honolulu, Hawaii, United States, 96814-4526
        • East-West Medical Research Institute
    • Idaho
      • Blackfoot, Idaho, United States, 83221
        • Bingham Memorial Hospital
      • Meridian, Idaho, United States, 83642
        • Velocity Clinical Research - Boise
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Great Lakes Clinical Trials
      • Chicago, Illinois, United States, 60608
        • Emvenio Research
      • Melrose Park, Illinois, United States, 60160
        • DM Clinical Research- River Forest
    • Indiana
      • Valparaiso, Indiana, United States, 46383
        • Velocity Clinical Research - Valparaiso
    • Iowa
      • Sioux City, Iowa, United States, 51106
        • Velocity Clinical Research-Sioux City
    • Kansas
      • Augusta, Kansas, United States, 67010
        • Alliance for Multispecialty Research
      • Lenexa, Kansas, United States, 66219-1376
        • Johnson County Clin-Trials (JCCT)
      • Overland Park, Kansas, United States, 66209
        • DelRicht Research - Overland Park
      • Wichita, Kansas, United States, 67207
        • AMR
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Velocity Clinical Research - Baton Rouge
      • Lafayette, Louisiana, United States, 70508
        • Velocity Clinical Research - Lafayette
      • Monroe, Louisiana, United States, 71201
        • IMA Clinical Research Monroe
      • New Orleans, Louisiana, United States, 70115
        • DelRicht Research
      • New Orleans, Louisiana, United States, 70119
        • Velocity Clinical Research
      • Prairieville, Louisiana, United States, 70769-4212
        • DelRicht Research @ Neighborhood Health
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Privia Medical Group
      • Gaithersburg, Maryland, United States, 20877
        • Cenexel CBH (CBH Health)
      • Rockville, Maryland, United States, 20852
        • Matthew Mintz Clinic
      • Rockville, Maryland, United States, 20854
        • Velocity Clinical Research - Covington
    • Massachusetts
      • Brookline, Massachusetts, United States, 02446
        • DM Clinical Research - Brookline
    • Michigan
      • Southfield, Michigan, United States, 48076
        • DM Clinical Research
      • Southfield, Michigan, United States, 48075-5400
        • Great Lakes Research Institute
      • Southfield, Michigan, United States, 48034
        • Headlands Research - Detroit
    • Mississippi
      • Gulfport, Mississippi, United States, 39503
        • DelRicht Research at Gulfport Memorial
    • Missouri
      • Chesterfield, Missouri, United States, 63005
        • Clinical Research Professionals
      • Springfield, Missouri, United States, 65807
        • Clinvest
      • Springfield, Missouri, United States, 65807
        • DelRicht Research
      • St Louis, Missouri, United States, 63141
        • Sundance Clinical Research, LLC
      • Town and Country, Missouri, United States, 63017
        • Delricht
    • Montana
      • Missoula, Montana, United States, 59804
        • Boeson Research MSO
      • Missoula, Montana, United States, 59808
        • Elias Research Associates
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • Velocity Clinical Research-Grand Island
      • Lincoln, Nebraska, United States, 68510
        • Platinum Research Network, LLC
      • Norfolk, Nebraska, United States, 68701
        • Velocity Clinical Research-Norfolk
      • Omaha, Nebraska, United States, 68134
        • Velocity Clinical Research-Omaha
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Henderson Clinical Trials
      • Las Vegas, Nevada, United States, 89106
        • M3 Wake Research/CRCN, LLC
      • Las Vegas, Nevada, United States, 89119
        • Office of Michael B. Jacobs, MD
    • New Jersey
      • Jersey City, New Jersey, United States, 07306
        • DM Clinical Research - New Jersey
      • Warren Township, New Jersey, United States, 07059
        • IMA Clinical Research Warren
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • DM Clinical Research-Albuquerque
      • Albuquerque, New Mexico, United States, 87109
        • AXCES Research Group - Sante Fe
    • New York
      • Binghamton, New York, United States, 13905
        • Velocity Clinical Research - Binghamton
      • Brooklyn, New York, United States, 11220
        • DM Clinical
      • Buffalo, New York, United States, 14217
        • RCR Buffalo
      • East Syracuse, New York, United States, 13057
        • Velocity Clinical Research, Syracuse
      • Hartsdale, New York, United States, 10530
        • IMA Clinical Research
      • New York, New York, United States, 10036
        • IMA Research
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research, Inc
      • Vestal, New York, United States, 13850
        • Velocity Clinical Research-Vestal
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Asheville Clinical Research
      • Charlotte, North Carolina, United States, 28205
        • DelRicht Research, LLC
      • Morehead City, North Carolina, United States, 23730
        • Lucas Research
      • Raleigh, North Carolina, United States, 27612
        • M3 Wake Research, Inc.
      • Raleigh, North Carolina, United States, 27607
        • Eximia Clinical Research
      • Salisbury, North Carolina, United States, 28144
        • Accellacare US Inc.
      • Wilmington, North Carolina, United States, 28403
        • Trial Management Associates, LLC
      • Wilmington, North Carolina, United States, 28401
        • Accellacare Research Wilmington
      • Winston-Salem, North Carolina, United States, 27157
        • Javara - Wake Forest University Health Sciences
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Velocity Clinical Research - Cincinnati
      • Cincinnati, Ohio, United States, 45212
        • Community Research
      • Cincinnati, Ohio, United States, 45219
        • Velocity Clinical Research-Mt. Auburn
      • Columbus, Ohio, United States, 43213
        • Centricity Research Columbus
      • Dayton, Ohio, United States, 45417
        • Midwest Clinical Research Center
    • Oklahoma
      • Edmond, Oklahoma, United States, 73013
        • Tekton Research, Inc - Edmond
      • Tulsa, Oklahoma, United States, 74133
        • Delricht Tate
      • Yukon, Oklahoma, United States, 73099
        • Tekton Research, Inc - Yukon Location
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • The Corvallis Clinic
      • Portland, Oregon, United States, 97210
        • Summit Research
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • DM Clinical Research - Philadelphia
      • Uniontown, Pennsylvania, United States, 15401
        • Preferred Primary Care Physicians
    • Rhode Island
      • Providence, Rhode Island, United States, 02886
        • Velocity Clinical Research - Providence
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Velocity Clinical Research - Anderson
      • Charleston, South Carolina, United States, 29407
        • DelRicht Research
      • Charleston, South Carolina, United States, 29414
        • Charleston Clinical Trials, LLC
      • Columbia, South Carolina, United States, 29204
        • Velocity Clinical Research, Spartanburg
      • Gaffney, South Carolina, United States, 29340
        • Velocity Clinical Research, Gaffney
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Health Specialists
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Medical Research
      • Union, South Carolina, United States, 29379
        • Velocity Clinical Research- Union
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Black Hills Center for American Indian Health
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • M3 Wake Research/ClinSearch, LLC
      • Jackson, Tennessee, United States, 38305
        • Helios Clinical Research
      • Johnson City, Tennessee, United States, 37601
        • MultiSpeciality Clinical Research
    • Texas
      • Austin, Texas, United States, 78745
        • Tekton Research, Inc
      • Austin, Texas, United States, 78745
        • Avant Reseach Associates
      • Beaumont, Texas, United States, 78705
        • Tekton Research, LLC
      • Brownsville, Texas, United States, 78526
        • Headlands Research Brownsville
      • El Paso, Texas, United States, 79225
        • 3A Research, LLC
      • Fort Worth, Texas, United States, 76135
        • Benchmark Research
      • Fort Worth, Texas, United States, 76104
        • Helios
      • Houston, Texas, United States, 77065
        • DM Clinical Research - CyFair
      • Houston, Texas, United States, 77008-1374
        • Helios Clinical Research
      • Houston, Texas, United States, 77081
        • DM Clinical Research- Bellaire
      • Keller, Texas, United States, 76248
        • Helios CR, Inc. Keller Tx
      • Plano, Texas, United States, 75093
        • Research Your Health
      • Prosper, Texas, United States, 75078
        • Delricht Research At Zomnir Family Medicine
      • San Antonio, Texas, United States, 78207
        • DM Clinical Research
      • San Antonio, Texas, United States, 78229
        • IMA Clinical Research
      • San Antonio, Texas, United States, 78229
        • Tekton Research Inc - San Antonio
      • San Marcos, Texas, United States, 78666
        • San Marcos Family Medicine
      • Stephenville, Texas, United States, 76401
        • Stephenville Medical & Surgical Clinic, PA
      • Sugar Land, Texas, United States, 77478
        • DM Clinical Research - Sugarland
      • Sugar Land, Texas, United States, 77478
        • Breco Research - A Tarheel Clinical Research Site
      • Tomball, Texas, United States, 77375
        • DM Clinical Research
      • Tomball, Texas, United States, 77375
        • DM Clinical Research - Tomball
    • Utah
      • Salt Lake City, Utah, United States, 84109
        • J. Lewis Research, Inc. / Foothill Family Clinic
      • Salt Lake City, Utah, United States, 84121
        • J. Lewis Research, Inc.
      • Salt Lake City, Utah, United States, 84107
        • CenExel - JBR
      • Salt Lake City, Utah, United States, 84106
        • Synexus Clinical Research US, Inc.
      • South Jordan, Utah, United States, 84095
        • J. Lewis Research, Inc/Jordan River Family Medicine
    • Virginia
      • Alexandria, Virginia, United States, 22311
        • Javara
      • Hampton, Virginia, United States, 23666-5843
        • Velocity Clinical Research-Hampton
      • Newport News, Virginia, United States, 23606-4537
        • Health Research of Hampton Roads, Inc.
      • Portsmouth, Virginia, United States, 23702
        • Velocity Clinical Research-Portsmouth
      • Richmond, Virginia, United States, 23226
        • Clinical Research Partners, LLC
      • Winchester, Virginia, United States, 22601
        • Amherst Family Practice
    • Washington
      • Spokane, Washington, United States, 99218
        • Velocity Clinical Research- Spokane
      • Wenatchee, Washington, United States, 98801
        • Confluence Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.

  • Participants who are assigned female at birth or can become pregnant are eligible to participate if:

    • The participant is a person of nonchildbearing potential (PONCBP) or
    • The participant is a person of childbearing potential (POCBP) who:
  • Is not breast/chest feeding.
  • Is using an acceptable contraceptive method at least 28 days prior to Day 1 (Baseline) to at least 90 days after Day 1 (Baseline).
  • Has a negative highly sensitive pregnancy test (urine or serum as required by local regulation or institutional review board [IRB]/independent ethics committee [IEC]) at the Screening Visit and before study intervention (if the Day 1 [Baseline] Visit is not on the same day as the Screening Visit).

Exclusion Criteria:

  • Acutely ill or febrile (temperature ≥38.0 degrees Celsius (℃) [100.4° Fahrenheit [F]]) within 72 hours prior to Day 1 (Baseline).
  • Close contact with someone with laboratory-confirmed influenza infection or with someone who has been treated with antiviral therapies for influenza (for example, Tamiflu®/oseltamivir) within 5 days prior to Day 1 (Baseline).
  • 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.
  • Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infections disease.
  • Tested positive for influenza by local health authority-approved testing methods within 180 days prior to Day 1 (Baseline).
  • History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any of the following: mRNA vaccine or therapeutic; components of an mRNA vaccine or therapeutic; influenza vaccine; or components of an influenza vaccine, including egg protein.
  • Malignancy within 2 years prior to Day 1 (Baseline) (adequately treated basal cell carcinoma and squamous cell carcinoma are allowed).
  • Received corticosteroids at ≥10 milligram (mg)/day of prednisone or equivalent for >14 days in total within 90 days prior to Day 1 (Baseline) or is anticipating the need for corticosteroids at any time during the study.
  • Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses (for example, infliximab), within 180 days prior to Day 1 (Baseline) or plans to do so during the study.
  • Treated with antiviral therapies for influenza (for example, Tamiflu) within 180 days prior to Day 1 (Baseline).
  • Received any vaccine authorized or approved by local health agency within 28 days prior to Day 1 (Baseline) or plans to do so within 14 days after Day 1 (Baseline).
  • Received a licensed seasonal influenza vaccine within 180 days prior to Day 1 (Baseline) or plans to do so (outside of this study) at any time during the study.
  • Received an investigational seasonal influenza vaccine within 1 year prior to Day 1 (Baseline). Note: participants from mRNA-1010-P304 Season 1 are NOT eligible to re enroll into Season 2.
  • Participated in a clinical study with investigational treatment within 90 days prior to Day 1 (Baseline) based on the medical history interview or plans to do so while participating in this study.
  • Is working or has worked as study personnel or is an immediate family member or house member of study personnel, study staff, or Sponsor personnel.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mRNA-1010
Participants will receive a single injection of mRNA-1010 on Day 1.
Biological: mRNA-1010
Intramuscular (IM) injection
Active Comparator: Fluarix®, Fluarix Tetra, Influsplit® Tetra, Alpharix® Tetra
Participants will receive a single injection of active comparator trivalent influenza vaccine (TIV) or quadrivalent influenza vaccine (QIV) (Fluarix®, Fluarix Tetra, Influsplit® Tetra, Alpharix® Tetra) on Day 1.
Biological: Fluarix®
IM injection
Biological: Influsplit® Tetra
IM injection
Biological: Fluarix Tetra
IM injection
Biological: Alpharix® Tetra
IM injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time Frame: Day 1 to Day 7
Day 1 to Day 7
Number of Participants with Unsolicited Adverse Events (AEs)
Time Frame: Day 1 to Day 28
Day 1 to Day 28
Number of Participants with Medically Attended AEs (MAAEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), or Adverse Events of Special Interest (AESI)
Time Frame: Day 1 to Day 181
Day 1 to Day 181
Time to First Episode of RT-PCR Confirmed Protocol Defined ILI
Time Frame: Day 14 up to End of Season (up to approximately Day 181)
ILI caused by any influenza A or B strains.
Day 14 up to End of Season (up to approximately Day 181)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI)
Time Frame: Day 29
Humoral immunogenicity.
Day 29
Number of Participants Reaching Seroconversion as Measured by HAI
Time Frame: Day 29
Day 29
Number of Participants with an HAI Titer ≥1:40
Time Frame: Day 29
Day 29
Geometric Mean Fold Rise (GMFR) of HAI Titers
Time Frame: Day 1, Day 29
Day 1, Day 29
Number of Participants with First Episode of RT-PCR-Confirmed Protocol-Defined ILI
Time Frame: Day 14 up to End of Season (up to approximately Day 181)
Correlates of Risk (CoR) and Correlates of Protection (CoP).
Day 14 up to End of Season (up to approximately Day 181)
Number of Participants with First Episode of RT-PCR Confirmed Modified US Centers for Disease Control and Prevention (CDC)-Defined ILI
Time Frame: Day 14 up to End of Season (up to approximately Day 181)
ILI caused by any influenza A or B strains.
Day 14 up to End of Season (up to approximately Day 181)
Number of Participants with First Episode of RT-PCR Confirmed Protocol-Defined ILI or Modified CDC-Defined ILI
Time Frame: Day 14 up to End of Season (up to approximately Day 181)
ILI caused by influenza A or B strains with antigenic match to the vaccine strains.
Day 14 up to End of Season (up to approximately Day 181)
HAI Titers
Time Frame: Day 29
As measured by the HAI Assay.
Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ModernaTX, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2024

Primary Completion (Actual)

August 21, 2025

Study Completion (Actual)

August 21, 2025

Study Registration Dates

First Submitted

September 15, 2024

First Submitted That Met QC Criteria

September 15, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 10, 2025

Last Update Submitted That Met QC Criteria

September 8, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mRNA-1010-P304
  • 2024-516240-26-00 (Other Identifier: EU CT)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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