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En studie av mRNA-1010 sammenlignet med en lisensiert influensavaksine hos voksne ≥50 år

20. august 2026 oppdatert av: ModernaTX, Inc.

En fase 3, randomisert, observatørblind, aktiv-kontrollert, case-drevet studie for å undersøke sikkerheten, effekten og immunogenisiteten til mRNA-1010 kandidat for sesonginfluensavaksine sammenlignet med en lisensiert inaktivert sesonginfluensavaksine hos voksne ≥50 år.

Hovedmålene med denne studien er å evaluere sikkerheten og reaktogenisiteten til mRNA-1010, og å evaluere relativ vaksineeffektivitet (rVE) av mRNA-1010 versus en aktiv komparator mot protokolldefinert influensalignende sykdom (ILI) forårsaket av enhver influensa A- eller B-stammer.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

40805

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

Inkluderingskriterier:

  • I stand til å gi signert informert samtykke, som inkluderer overholdelse av kravene og begrensningene som er oppført i skjemaet for informert samtykke (ICF) og i protokollen.

  • Deltakere som tildeles kvinner ved fødselen eller kan bli gravide er kvalifisert til å delta hvis:

    • Deltakeren er en person med ikke-fertil potensial (PONCBP) eller
    • Deltakeren er en person i fertil alder (POCBP) som:
  • Er ikke amming/brystmating.
  • Bruker en akseptabel prevensjonsmetode minst 28 dager før dag 1 (grunnlinje) til minst 90 dager etter dag 1 (grunnlinje).
  • Har en negativ svært sensitiv graviditetstest (urin eller serum som kreves av lokale forskrifter eller institusjonell vurderingskomité [IRB]/uavhengig etisk komité [IEC]) ved screeningbesøket og før studieintervensjon (hvis dag 1 [Baseline]-besøket ikke er det samme dag som visningsbesøket).

Ekskluderingskriterier:

  • Akutt syk eller febril (temperatur ≥38,0 grader Celsius (℃) [100,4° Fahrenheit [F]]) innen 72 timer før dag 1 (grunnlinje).
  • Nær kontakt med noen med laboratoriebekreftet influensainfeksjon eller med noen som har blitt behandlet med antivirale terapier for influensa (for eksempel Tamiflu®/oseltamivir) innen 5 dager før dag 1 (grunnlinje).
  • Historie om en diagnose eller tilstand som etter etterforskerens vurdering er klinisk ustabil eller kan påvirke deltakersikkerheten, vurdering av studiens endepunkter, vurdering av immunrespons eller overholdelse av studieprosedyrer.
  • Rapportert historie med medfødt eller ervervet immunsvikt, immunsuppressiv tilstand, aspleni eller tilbakevendende alvorlig infeksjonssykdom.
  • Testet positivt for influensa av lokale helsemyndigheter-godkjente testmetoder innen 180 dager før dag 1 (grunnlinje).
  • Anamnese med anafylaksi eller alvorlig overfølsomhetsreaksjon som krever medisinsk intervensjon etter mottak av noen av følgende: mRNA-vaksine eller terapeutisk; komponenter av en mRNA-vaksine eller terapeutisk middel; influensavaksine; eller komponenter av en influensavaksine, inkludert eggprotein.
  • Malignitet innen 2 år før dag 1 (grunnlinje) (tilstrekkelig behandlet basalcellekarsinom og plateepitelkarsinom er tillatt).
  • Mottok kortikosteroider med ≥10 milligram (mg)/dag prednison eller tilsvarende i >14 dager totalt innen 90 dager før dag 1 (grunnlinje) eller forventer behov for kortikosteroider når som helst i løpet av studien.
  • Fikk systemisk immunsuppressiv behandling, inkludert langtidsvirkende biologiske terapier som påvirker immunresponser (for eksempel infliksimab), innen 180 dager før dag 1 (grunnlinje) eller planlegger å gjøre det under studien.
  • Behandlet med antivirale terapier for influensa (for eksempel Tamiflu) innen 180 dager før dag 1 (grunnlinje).
  • Mottatt enhver vaksine autorisert eller godkjent av lokale helsemyndigheter innen 28 dager før dag 1 (grunnlinje) eller planlegger å gjøre det innen 14 dager etter dag 1 (grunnlinje).
  • Mottok en lisensiert sesonginfluensavaksine innen 180 dager før dag 1 (grunnlinje) eller planlegger å gjøre det (utenfor denne studien) når som helst i løpet av studien.
  • Mottok en undersøkelsesvaksine mot sesonginfluensa innen 1 år før dag 1 (grunnlinje).
  • Deltok i en klinisk studie med undersøkelsesbehandling innen 90 dager før dag 1 (grunnlinje) basert på sykehistorieintervjuet eller planlegger å gjøre det mens han deltok i denne studien.
  • Arbeider eller har jobbet som studiepersonell eller er et nært familiemedlem eller husmedlem av studiepersonell, studiepersonell eller fadderpersonell.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: mRNA-1010
Deltakerne vil motta en enkelt injeksjon av mRNA-1010 på dag 1.
Biologisk: mRNA-1010
Intramuskulær (IM) injeksjon
Aktiv komparator: Fluarix®, Fluarix Tetra, Influsplit® Tetra, Alpharix® Tetra
Deltakerne vil motta en enkelt injeksjon av aktiv komparator -trivalent influensavaksine (TIV) eller kvadrivalent influensavaksine (QIV) (Fluarix®, Fluarix Tetra, Influsplit® Tetra, Alpharix® Tetra) på dag 1.
Biologisk: Fluarix®
IM-injeksjon
Biologisk: InflusPlit® Tetra
Im injeksjon
Biologisk: Fluarix Tetra
Im injeksjon
Biologisk: Alpharix® Tetra
Im injeksjon

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Tidsramme: Day 1 up to Day 7
Solicited ARs were recorded daily using electronic diaries (eDiaries). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered adverse events (AEs). Investigator reviewed whether the solicited AR was also to be recorded as an AE. A summary of all Serious Adverse Events (SAEs) and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Day 1 up to Day 7
Number of Participants With Unsolicited Adverse Events (AEs)
Tidsramme: Day 1 up to Day 28
An unsolicited AE was defined as any AE reported by the participant that was not specified as a solicited AR in the protocol. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A summary of all SAEs and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Day 1 up to Day 28
Number of Participants With Medically Attended AEs (MAAEs), AEs Leading to Study Discontinuation, SAEs, or Adverse Events of Special Interests (AESIs)
Tidsramme: Day 1 up to Day 181
MAAEs were AEs that led to an unscheduled visit to a healthcare provider. SAEs were AEs that resulted in death, were life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly or birth defect, or was a medically important event. AESIs were AEs (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program for which ongoing monitoring and immediate notification by the investigator to the Sponsor was required. A summary of all SAEs and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Day 1 up to Day 181
Number of Participants With First Episode of Reverse Tanscription Polymerase Chain Reaction (RT-PCR) Confirmed Protocol Defined Influenza-like Illness (ILI) Caused by Any Influenza A or B Strains
Tidsramme: Day 14 up to end of influenza season (up to 7.5 months)
Protocol-defined ILI: At least 1 systemic symptom (temperature >37.2 degrees celsius [°C] [>99.0 degrees Fahrenheit {°F}], chills, feverish, tiredness, headaches, or myalgia) and at least 1 respiratory symptom (sore throat, cough, sputum production, wheezing, or difficulty breathing).
Day 14 up to end of influenza season (up to 7.5 months)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants With First Episode of RT-PCR Confirmed Modified United States (US) Centers for Disease Control and Prevention (CDC)-Defined ILI Caused by Any Influenza A or B Strains
Tidsramme: Day 14 up to end of influenza season (up to 7.5 months)
Modified CDC-defined ILI: Body temperature ≥37.2°C (≥99.0°F) accompanied by cough and/or sore throat.
Day 14 up to end of influenza season (up to 7.5 months)
Number of Participants With First Episode of RT-PCR-confirmed Protocol-defined ILI or Modified CDC-defined ILI Caused by Any Influenza A or B Strains With Antigenic Match to the Vaccine Strains
Tidsramme: Day 14 up to end of influenza season (up to 7.5 months)
Protocol-defined ILI: At least 1 systemic symptom (temperature >37.2°C [>99.0°F], chills, feverish, tiredness, headaches, or myalgia) and at least 1 respiratory symptom (sore throat, cough, sputum production, wheezing, or difficulty breathing). Modified CDC-defined ILI: Body temperature >37.2°C (>99.0°F) accompanied by cough and/or sore throat. The confirmed RT-PCR test of influenza A or B strains with antigentic match to the vaccine strains.
Day 14 up to end of influenza season (up to 7.5 months)
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI)
Tidsramme: Day 29
Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strain included Victoria. Antibody values reported as below lower limit of quantification (LLOQ) were replaced by 0.5 * LLOQ. Values greater than upper limit of quantification (ULOQ) were converted to ULOQ. LLOQ = 10, ULOQ = 3620 for H1N1. LLOQ = 10, ULOQ = 2560 for H3N2. LLOQ = 10, ULOQ = 1356. 95% confidence interval (CI) was calculated based on the t-distribution of log-transformed values for geometric mean (GM) titer, then back transformed to original scale for presentation.
Day 29
Number of Participants Reaching Seroconversion as Measured by HAI
Tidsramme: Day 29
Seroconversion was defined as either a Baseline HAI titer <1:10 and a post-baseline titer ≥1:40 or a Baseline HAI titer ≥1:10 and a minimum 4-fold rise in post-baseline HAI antibody titer. Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strain included Victoria.
Day 29
Number of Participants With an HAI Titer ≥1:40
Tidsramme: Day 29
Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strain included Victoria.
Day 29
Geometric Mean Fold Rise (GMFR) of HAI Titers
Tidsramme: Baseline, Day 29
Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strain included Victoria. 95% CI was calculated based on the t-distribution of the difference in the log-transformed values for GM fold rise, then back transformed to the original scale for presentation.
Baseline, Day 29

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

ModernaTX, Inc.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

16. september 2024

Primær fullføring (Faktiske)

21. august 2025

Studiet fullført (Faktiske)

21. august 2025

Datoer for studieregistrering

Først innsendt

15. september 2024

Først innsendt som oppfylte QC-kriteriene

15. september 2024

Først lagt ut (Faktiske)

19. september 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • mRNA-1010-P304
  • 2024-516240-26-00 (Annen identifikator: EU CT)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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