Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

En studie for å evaluere effektiviteten og sikkerheten til mRNA-1283 og mRNA-1273 hos deltakere i alderen 50 til 64 år uten høye risikofaktorer for alvorlig koronavirus-sykdom 2019 (COVID-19)

23. september 2026 oppdatert av: ModernaTX, Inc.

En fase 4, randomisert, observatørblind, placebokontrollert studie for å evaluere effekt og sikkerhet av mRNA-1283 og mRNA-1273 variantinneholdende formulering hos voksne fra 50 til 64 år uten underliggende tilstander som gjør dem til høy risiko for alvorlig utfall fra COVID-19

The purpose of this study is to evaluate the efficacy and safety of mRNA-1283 and mRNA-1273 (variant formulations) in adults 50 to 64 years of age without high risk factors for severe COVID-19.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

30000

Fase

  • Fase 4

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35216
        • Accel Clinical Research
      • Cullman, Alabama, Forente stater, 35055
        • Cullman Clinical Trials
      • Mobile, Alabama, Forente stater, 36608
        • Velocity Clinical Research, Mobile
      • Mobile, Alabama, Forente stater, 36608
        • AMR Clinical Mobile
    • Arizona
      • Glendale, Arizona, Forente stater, 85308
        • Lenzmeier Family Medicine - Avacare
      • Mesa, Arizona, Forente stater, 85213
        • Desert Clinical Research
      • Phoenix, Arizona, Forente stater, 85006
        • Velocity Clinical Research - Phoenix
      • Phoenix, Arizona, Forente stater, 85044
        • Foothills Research Center/Avacare
      • Scottsdale, Arizona, Forente stater, 85260
        • Headlands Research Scottsdale
      • Tempe, Arizona, Forente stater, 85283
        • Fiel Family and Sports Medicine / Avacare
    • California
      • Colton, California, Forente stater, 92324
        • Avacare
      • Garden Grove, California, Forente stater, 92845
        • CenExel CNR
      • Huntington Park, California, Forente stater, 90255
        • Velocity Clinical Research, Huntington Park
      • La Mesa, California, Forente stater, 91942
        • Velocity Clinical Research - San Diego - ERN - PPDS-Site Number:8400010
      • Los Angeles, California, Forente stater, 90017
        • Velocity Clinical Research - Los Angeles
      • Riverside, California, Forente stater, 92503
        • Artemis Institute for Clinical Research
      • Rolling Hills Estates, California, Forente stater, 90274
        • Peninsula Research Associates
      • San Bernardino, California, Forente stater, 92408
        • Velocity Clinical Research -- Banning
      • San Diego, California, Forente stater, 92103
        • Artemis Institute for Clinical Research
    • Colorado
      • Denver, Colorado, Forente stater, 80238
        • Tekton Research, LLC
      • Fort Collins, Colorado, Forente stater, 80525
        • Tekton Research, LLC
      • Lakewood, Colorado, Forente stater, 80228
        • Critical Care, Pulmonary and Sleep Associates, P.LLP/Avacare
      • Longmont, Colorado, Forente stater, 80501
        • Tekton Research, LLC
    • Connecticut
      • Bridgeport, Connecticut, Forente stater, 06606
        • New England Research Associates
      • Stamford, Connecticut, Forente stater, 06905
        • Stamford Therapeutics Consortium
    • District of Columbia
      • Washington D.C., District of Columbia, Forente stater, 20016
        • Velocity Clinical Research-Washington, DC
    • Florida
      • DeLand, Florida, Forente stater, 32720
        • Hillcrest Medical Research, LLC
      • DeLand, Florida, Forente stater, 32720
        • University Clinical Research-Deland, LLC d/b/a Accel Research Sites - Deland Clinical Research Unit
      • Doral, Florida, Forente stater, 33172
        • Suncoast Research Associates, LLC
      • Hallandale, Florida, Forente stater, 33009
        • Velocity Clinical Research, Hallandale Beach
      • Hialeah, Florida, Forente stater, 33012
        • Indago Research & Health Center, Inc
      • Hollywood, Florida, Forente stater, 33024
        • CenExel Research Centers of America
      • Hollywood, Florida, Forente stater, 33024
        • NextPhase Research Florida
      • Jupiter, Florida, Forente stater, 33458
        • Health Awareness Inc.
      • Lakeland, Florida, Forente stater, 33803
        • Sandhill Research, LLC d/b/a Accel Research Sites - Lakeland Clinical Research Unit
      • Largo, Florida, Forente stater, 33777
        • Sandhill Research, LLC d/b/a Accel Research Sites- St. Pete-Largo Clinical Research Unit
      • Maitland, Florida, Forente stater, 32751
        • Accel Research Sites
      • Miami Lakes, Florida, Forente stater, 33016
        • Global Health Research Center, Inc.
      • New Port Richey, Florida, Forente stater, 34652
        • Suncoast Clinical Research
      • Orlando, Florida, Forente stater, 32819
        • Headlands Research Orlando
      • Palmetto Bay, Florida, Forente stater, 33157
        • Innovation Medical Research Center
      • Tampa, Florida, Forente stater, 33613
        • ForCare Clinical Research
      • Tampa, Florida, Forente stater, 33615
        • Global Health Research Center, Inc.
    • Georgia
      • Albany, Georgia, Forente stater, 31707
        • Javara Inc. and PRIVIA Medical Group of Georgia, LLC
      • Atlanta, Georgia, Forente stater, 30331
        • Atlanta Center for Medical Research
      • Atlanta, Georgia, Forente stater, 30329
        • DelRicht Research
      • Decatur, Georgia, Forente stater, 30030
        • CenExel iResearch, LLC
      • Decatur, Georgia, Forente stater, 30030
        • Accel Research Sites - Neurostudies
      • Fayetteville, Georgia, Forente stater, 30214
        • Javara Inc. and Privia Medical Group of Georgia, LLC
      • Savannah, Georgia, Forente stater, 31406
        • Velocity Clinical Research Savannah
      • Stockbridge, Georgia, Forente stater, 30281
        • Clinical Research Atlanta
    • Idaho
      • Meridian, Idaho, Forente stater, 83642
        • Velocity Clinical Research - Boise - ERN - PPDS
    • Illinois
      • Melrose Park, Illinois, Forente stater, 60160
        • DM Clinical Research - Melrose Park
    • Indiana
      • Valparaiso, Indiana, Forente stater, 46383
        • Velocity Clinical Research Valparaiso
    • Iowa
      • Sioux City, Iowa, Forente stater, 51106
        • Velocity Clinical Research - Sioux City
    • Kansas
      • Lenexa, Kansas, Forente stater, 66212
        • Johnson County Clin-Trials
      • Wichita, Kansas, Forente stater, 67218
        • Tekton Research, LLC
    • Kentucky
      • Louisville, Kentucky, Forente stater, 40205
        • DelRicht Research
      • Versailles, Kentucky, Forente stater, 40383
        • Versailles Family Medicine - CCT Research
    • Louisiana
      • Baton Rouge, Louisiana, Forente stater, 70809
        • Velocity Clinical Research-Baton Rouge
      • Covington, Louisiana, Forente stater, 70433
        • Velocity Clinical Research - Covington
      • Kenner, Louisiana, Forente stater, 70065
        • Avacare
      • Lafayette, Louisiana, Forente stater, 70508
        • Velocity Clinical Research, Lafayette
      • Mandeville, Louisiana, Forente stater, 70471
        • DelRicht Research
      • New Orleans, Louisiana, Forente stater, 70115
        • DelRicht Research
      • New Orleans, Louisiana, Forente stater, 70119
        • Velocity Clinical Research, New Orleans
      • Prairieville, Louisiana, Forente stater, 70769
        • DelRicht Research
    • Maryland
      • Annapolis, Maryland, Forente stater, 21401
        • Annapolis Internal Medicine
      • Columbia, Maryland, Forente stater, 21045
        • Centennial Medical Group
      • Rockville, Maryland, Forente stater, 20854
        • Velocity Clinical Research, Rockville
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02115
        • Brigham and Women's Hospital
      • Brookline, Massachusetts, Forente stater, 02446
        • DM Clinical Research - Brookline
      • Methuen, Massachusetts, Forente stater, 01844
        • ActivMed Practices & Research, LLC
    • Michigan
      • Southfield, Michigan, Forente stater, 48076
        • DM Clinical Research - Southfield
      • Southfield, Michigan, Forente stater, 48034
        • Headlands Research Detroit
    • Minnesota
      • Mankato, Minnesota, Forente stater, 56001
        • Javara Inc. and Mankato Clinic, Ltd.
    • Mississippi
      • Gulfport, Mississippi, Forente stater, 39503
        • Velocity Clinical Research Gulfport
    • Missouri
      • Chesterfield, Missouri, Forente stater, 63005
        • Clinical Research Professionals
      • Kansas City, Missouri, Forente stater, 64151
        • Clay-Platte Family Medicine Clinic
      • Kansas City, Missouri, Forente stater, 64116
        • AMR Clinical
      • 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 Research
    • Nebraska
      • Fremont, Nebraska, Forente stater, 68025
        • Avacare Research/Methodist Physicians Clinic
      • Grand Island, Nebraska, Forente stater, 68803
        • Velocity Clinical Research, Grand Island
      • Lincoln, Nebraska, Forente stater, 68510
        • Velocity Clinical Research
      • Norfolk, Nebraska, Forente stater, 68701
        • Velocity Clinical Research Norfolk
      • Omaha, Nebraska, Forente stater, 68134
        • Velocity Clinical Research Omaha
      • Omaha, Nebraska, Forente stater, 68144
        • Avacare/Midwest Regional Health Services
      • Papillion, Nebraska, Forente stater, 68046
        • Papillion Research/Avacare
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89119
        • Santa Rosa Medical Centers of Nevada
    • New Jersey
      • Jersey City, New Jersey, Forente stater, 07306
        • DM Clinical Research - Jersey City
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87107
        • Velocity Clinical Research - Albuquerque
      • Albuquerque, New Mexico, Forente stater, 87106
        • DM Clinical Research - Albuquerque
    • New York
      • Rochester, New York, Forente stater, 14609
        • Rochester Clinical Research
    • North Carolina
      • Durham, North Carolina, Forente stater, 27701
        • Velocity Clinical Research, Durham
      • Raleigh, North Carolina, Forente stater, 27607
        • Eximia Research - NC, LLC
      • Wilmington, North Carolina, Forente stater, 28403
        • TMA Headlands LLC d/b/a Trial Management Associates
      • Winston-Salem, North Carolina, Forente stater, 27157
        • Wake Forest University Health Sciences
    • Ohio
      • Beachwood, Ohio, Forente stater, 44122
        • Velocity Clinical Research - Cleveland
      • Cincinnati, Ohio, Forente stater, 45212
        • CTI Clinical Research Center
      • Cincinnati, Ohio, Forente stater, 45246
        • Velocity Clinical Research Springdale
      • Cincinnati, Ohio, Forente stater, 45242
        • Velocity Clinical Research-Mt. Auburn
    • Oklahoma
      • Edmond, Oklahoma, Forente stater, 73013
        • Tekton Research, LLC
      • Moore, Oklahoma, Forente stater, 73160
        • Tekton Research, LLC
      • Tulsa, Oklahoma, Forente stater, 74133
        • DelRicht Research
      • Yukon, Oklahoma, Forente stater, 73099
        • Tekton Research, LLC
    • Oregon
      • Medford, Oregon, Forente stater, 97504
        • Velocity Clinical Research - Medford
      • Portland, Oregon, Forente stater, 97210
        • Summit Headlands LLC
    • Pennsylvania
      • Horsham, Pennsylvania, Forente stater, 19044
        • Hatboro Medical Associates/Avacare
      • Philadelphia, Pennsylvania, Forente stater, 19107
        • DM Clinical Research - Philadelphia
    • Rhode Island
      • East Greenwich, Rhode Island, Forente stater, 02818
        • Velocity Clinical Research - East Greenwich
    • South Carolina
      • Anderson, South Carolina, Forente stater, 29621
        • Velocity Clinical Research, Anderson
      • Charleston, South Carolina, Forente stater, 29407
        • DelRicht Research
      • Columbia, South Carolina, Forente stater, 29204
        • Velocity Clinical Research - Columbia
      • North Charleston, South Carolina, Forente stater, 29405
        • Coastal Carolina Research Center, LLC
      • Spartanburg, South Carolina, Forente stater, 29303
        • Velocity Clinical Research Spartanburg
      • Union, South Carolina, Forente stater, 29379
        • Velocity Clinical Research Union
    • Tennessee
      • Hendersonville, Tennessee, Forente stater, 37075
        • DelRicht Research
    • Texas
      • Abilene, Texas, Forente stater, 79606
        • Velocity Clinical Research, Abilene
      • Austin, Texas, Forente stater, 78745
        • Tekton Research, LLC
      • Austin, Texas, Forente stater, 78759
        • Velocity Clinical Research - Austin
      • Beaumont, Texas, Forente stater, 77706
        • Tekton Research, LLC
      • Conroe, Texas, Forente stater, 77384
        • Javara Inc. and Privia Medical Group Gulf Coast, PLLC
      • Dallas, Texas, Forente stater, 75230
        • Velocity Clinical Research - Dallas
      • Fort Worth, Texas, Forente stater, 76135
        • Avacare
      • Houston, Texas, Forente stater, 77065
        • DM Clinical Research - Houston
      • Houston, Texas, Forente stater, 77081
        • DM Clinical Research - Houston
      • Prosper, Texas, Forente stater, 75078
        • DelRicht Research
      • Round Rock, Texas, Forente stater, 78681
        • Be Well Clinical Studies
      • San Antonio, Texas, Forente stater, 78207
        • DM Clinical Research - San Antonio
      • San Antonio, Texas, Forente stater, 78229
        • Tekton Research, LLC
      • San Marcos, Texas, Forente stater, 78666
        • Javara Inc. and Privia Medical Group Gulf Coast, PLLC
      • Stephenville, Texas, Forente stater, 76401
        • Javara Inc. and Privia Medical Group - North Texas
      • Sugar Land, Texas, Forente stater, 77478
        • DM Clinical Research - Sugar Land
      • Sugar Land, Texas, Forente stater, 77478
        • Javara Inc. and Privia Medical Group Gulf Coast, PLLC
      • Sugar Land, Texas, Forente stater, 77479
        • Olympus Clinical Research
      • Tomball, Texas, Forente stater, 77375
        • DM Clinical Research - Tomball
    • Utah
      • Bountiful, Utah, Forente stater, 84010
        • Cope Family Medicine / Avacare
      • Pleasant View, Utah, Forente stater, 84404
        • Mountain View/Avacare
      • Salt Lake City, Utah, Forente stater, 84107
        • JBR Clinical Research
      • Salt Lake City, Utah, Forente stater, 84117
        • Olympus Family Medicine/Avacare
      • South Jordan, Utah, Forente stater, 84095
        • J. Lewis Research, Inc/Jordan River Family Medicine
      • South Ogden, Utah, Forente stater, 84405
        • South Ogden Family Medicine/ Avacare
      • West Jordan, Utah, Forente stater, 84088
        • Velocity Clinical Research - Salt Lake City (West Jordan)
    • Virginia
      • Charlottesville, Virginia, Forente stater, 22911
        • Charlottesville Medical Research, LLC
      • Hampton, Virginia, Forente stater, 23666
        • Velocity Clinical Research-Hampton
      • Richmond, Virginia, Forente stater, 23226
        • Clinical Research Partners, LLC
      • Suffolk, Virginia, Forente stater, 23435
        • Velocity Clinical Research - Suffolk
    • Washington
      • Spokane, Washington, Forente stater, 99218
        • Velocity Clinical Research, Spokane

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

50 år til 64 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Key Inclusion Criteria:

  • Healthy and without underlying medical conditions that may put them at higher risk of experiencing severe outcomes of COVID-19, as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.

Key Exclusion Criteria:

  • History of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 3 months prior to enrollment.

  • Acutely ill or febrile within 72 hours prior to or at the Screening Visit or Day 1.

  • Receipt of any of the following:

    • COVID-19 vaccine within 3 months prior to enrollment,
    • Any licensed non COVID-19 vaccine within 28 days before or planned receipt within 28 days after the study intervention, except an influenza vaccine, which may be given 14 days before or after receipt of the study intervention,
    • Corticosteroids at ≥10 milligrams (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 or,
    • Systemic immunosuppressive treatment within 180 days prior to the Screening or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study.

  • Has donated ≥450 mL of blood products within 28 days prior to the Screening Visit or plans to donate blood products within 28 days post study injection.

  • Has participated in an investigational clinical study within 28 days prior to the Screening Visit based on the medical history interview or plans to do so while participating in this study.

Note: Additional inclusion/exclusion criteria may apply, per protocol.

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-1273 (Variant Formulation)

Participants will receive a single intramuscular (IM) injection of mRNA-1273 on Day 1.
Biologisk: mRNA-1273

Sterile liquid for injection
Eksperimentell: mRNA-1283 (Variant Formulation)

Participants will receive a single IM injection of mRNA-1283 on Day 1.
Biologisk: mRNA-1283

Sterile liquid for injection
Placebo komparator: Placebo

Participants will receive a single IM injection of placebo on Day 1.
Biologisk: Placebo

0.9% sodium chloride (normal saline) injection

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Antall deltakere med uoppfordrede bivirkninger (AEs)
Tidsramme: Dag 1 til og med Dag 28
Dag 1 til og med Dag 28
Antall deltakere med alvorlige bivirkninger (SAEs), medisinsk behandlede bivirkninger (MAAEs), bivirkninger av spesiell interesse (AESIs) og bivirkninger som førte til avbrudd
Tidsramme: Dag 1 til Dag 181
Dag 1 til Dag 181
VE of mRNA-1273 (Variant Formulation) to Prevent the First Event of COVID-19 after Study Injection
Tidsramme: Day 1 through Day 181

The VE is defined as the percent reduction in the hazard of the first event of COVID-19 after study injection (each vaccine arm versus placebo) and will be estimated using 1-hazard ratio (HR).
Day 1 through Day 181
Vaccine Efficacy (VE) of mRNA-1283 (Variant Formulation) to Prevent the First Event of COVID-19 after Study Injection
Tidsramme: Day 1 through Day 181

The VE is defined as the percent reduction in the hazard of the first event of COVID-19 after study injection (each vaccine arm versus placebo) and will be estimated using 1-hazard ratio (HR).
Day 1 through Day 181

Sekundære resultatmål

Resultatmål
Tidsramme
Antall deltakere med en første hendelse av alvorlig COVID-19 etter studieinnsprøyting
Tidsramme: Dag 1 til Dag 181
Dag 1 til Dag 181

Samarbeidspartnere og etterforskere

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

Sponsor

ModernaTX, Inc.

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)

26. november 2025

Primær fullføring (Antatt)

16. juni 2027

Studiet fullført (Antatt)

16. juni 2027

Datoer for studieregistrering

Først innsendt

25. november 2025

Først innsendt som oppfylte QC-kriteriene

25. november 2025

Først lagt ut (Faktiske)

5. desember 2025

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • mRNA-1273_1283-P401

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. .

Abonnere