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A Study on the Efficacy of a Vaccine Against Influenza in Adults ≥65 Years of Age

17. september 2026 oppdatert av: GlaxoSmithKline

A Phase 3 Randomized, Observer-Blind, Controlled Study to Evaluate the Clinical Efficacy of an mRNA Based Seasonal Influenza Vaccine in Older Adults ≥65 Years of Age

This study will compare an investigational mRNA flu vaccine with a licensed flu vaccine in adults 65 years of age and older. Participants will receive one injection and will be followed during the flu season. The study will measure prevention of laboratory-confirmed flu illness, side effects, and immune responses.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

54000

Fase

  • Fase 3

Kontakter og plasseringer

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

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      • Mesa, Arizona, Forente stater, 85206
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      • Scottsdale, Arizona, Forente stater, 85250
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      • Sun City, Arizona, Forente stater, 85351-2146
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      • Tempe, Arizona, Forente stater, 85284
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      • Little Rock, Arkansas, Forente stater, 72204
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    • California
      • Dublin, California, Forente stater, 94568-2453
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      • Escondido, California, Forente stater, 92025
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      • Fair Oaks, California, Forente stater, 95628
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      • La Palma, California, Forente stater, 90623
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      • Redding, California, Forente stater, 96001
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      • Riverside, California, Forente stater, 92503
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      • Rolling Hills Estates, California, Forente stater, 90274-3664
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      • San Bernardino, California, Forente stater, 92408
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      • San Diego, California, Forente stater, 92103
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      • Walnut Creek, California, Forente stater, 94598
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    • Colorado
      • Aurora, Colorado, Forente stater, 80012
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      • Colorado Springs, Colorado, Forente stater, 80909
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    • Connecticut
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      • Waterbury, Connecticut, Forente stater, 06708
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    • Florida
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      • Fort Lauderdale, Florida, Forente stater, 33308
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      • Hialeah, Florida, Forente stater, 33012
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      • Hialeah, Florida, Forente stater, 33016
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      • Homestead, Florida, Forente stater, 33030
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      • Lake Mary, Florida, Forente stater, 32720
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      • Lake Worth, Florida, Forente stater, 33462
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      • Maitland, Florida, Forente stater, 32751
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      • Melbourne, Florida, Forente stater, 32934-8172
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      • Miami, Florida, Forente stater, 33125
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      • Miami, Florida, Forente stater, 33186
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      • Miami, Florida, Forente stater, 33174
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      • Miami, Florida, Forente stater, 33134
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      • Miami, Florida, Forente stater, 33130
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      • Miami Lakes, Florida, Forente stater, 33016
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      • Miami Lakes, Florida, Forente stater, 33016-1597
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      • Orlando, Florida, Forente stater, 32803
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      • Orlando, Florida, Forente stater, 32806
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      • Palmetto Bay, Florida, Forente stater, 33157
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      • Port Orange, Florida, Forente stater, 32127-5169
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      • Tamarac, Florida, Forente stater, 33321
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      • Tampa, Florida, Forente stater, 33614
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      • Tampa, Florida, Forente stater, 33615
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      • The Villages, Florida, Forente stater, 32162
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      • West Palm Beach, Florida, Forente stater, 33409
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      • Morton, Illinois, Forente stater, 61550
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      • Peoria, Illinois, Forente stater, 61614
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      • Valparaiso, Indiana, Forente stater, 46383
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      • Kansas City, Kansas, Forente stater, 66112
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      • Lenexa, Kansas, Forente stater, 66219
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    • Louisiana
      • Lafayette, Louisiana, Forente stater, 70508
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      • New Orleans, Louisiana, Forente stater, 70115
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      • Baltimore, Maryland, Forente stater, 21208
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      • Boston, Massachusetts, Forente stater, 02131
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      • Brookline, Massachusetts, Forente stater, 02446
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      • Garden City, Michigan, Forente stater, 48135
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      • Southfield, Michigan, Forente stater, 48075
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      • Southfield, Michigan, Forente stater, 48034
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      • Gulfport, Mississippi, Forente stater, 39503
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      • Chesterfield, Missouri, Forente stater, 63005
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      • St Louis, Missouri, Forente stater, 63141
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      • St Louis, Missouri, Forente stater, 63141-6282
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    • Nebraska
      • Elkhorn, Nebraska, Forente stater, 68022
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          • William Fitzgibbons
      • Grand Island, Nebraska, Forente stater, 68803
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          • Adam Brosz
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      • Norfolk, Nebraska, Forente stater, 68701-7701
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          • Charles Harper
      • Omaha, Nebraska, Forente stater, 68114
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    • Nevada
      • Las Vegas, Nevada, Forente stater, 89106
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          • Stephen Tam
      • Las Vegas, Nevada, Forente stater, 89109
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          • Robby Quintos
    • New Jersey
      • Warren Township, New Jersey, Forente stater, 07059-2730
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    • New Mexico
      • Santa Fe, New Mexico, Forente stater, 87505
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          • Wendy Johnson
    • New York
      • Hartsdale, New York, Forente stater, 10530
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          • Michael Gerdis
      • Rochester, New York, Forente stater, 14609
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          • Patrick Connors
    • North Carolina
      • Charlotte, North Carolina, Forente stater, 28210
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          • Christina Kennelly
      • Denver, North Carolina, Forente stater, 80110
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      • Durham, North Carolina, Forente stater, 27704
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          • Sherif Naguib
      • Fayetteville, North Carolina, Forente stater, 30214
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          • Charlotte Mathis
      • Greensboro, North Carolina, Forente stater, 27408
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          • Alexander Murray
      • Hickory, North Carolina, Forente stater, 28601
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          • Scott Polster
      • Raleigh, North Carolina, Forente stater, 27527
        • Rekruttering
        • GSK Investigational Site
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          • Matthew Hong
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      • Salisbury, North Carolina, Forente stater, 28144
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          • Kishan Maramraj
      • Wilmington, North Carolina, Forente stater, 28403
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          • Barton Williams
      • Winston-Salem, North Carolina, Forente stater, 27103
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          • Jonathan Wilson
    • Ohio
      • Blue Ash, Ohio, Forente stater, 45242-3763
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          • Audrius Ruksenas
      • Cincinnati, Ohio, Forente stater, 45246
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      • Columbus, Ohio, Forente stater, 43213
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      • Lima, Ohio, Forente stater, 45801
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          • Nonso Ezema
    • Oklahoma
      • Chickasha, Oklahoma, Forente stater, 73018-2738
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Ahmad Musa
      • Oklahoma City, Oklahoma, Forente stater, 73111
        • Rekruttering
        • GSK Investigational Site
        • Hovedetterforsker:
          • Carl Griffin
        • Ta kontakt med:
        • Ta kontakt med:
      • Tulsa, Oklahoma, Forente stater, 74133
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Melita Tate
    • Oregon
      • Portland, Oregon, Forente stater, 97210-5311
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Andre Barkhuizen
    • Pennsylvania
      • Camp Hill, Pennsylvania, Forente stater, 17011
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Venkatesh Nadar
      • Philadelphia, Pennsylvania, Forente stater, 19107
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • David Wheeler
    • South Carolina
      • Anderson, South Carolina, Forente stater, 29621-4822
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Daniel Williams
      • Little River, South Carolina, Forente stater, 29569
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Stephen Grubb
      • Myrtle Beach, South Carolina, Forente stater, 29572
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Donald Eagerton
      • North Charleston, South Carolina, Forente stater, 29405
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Rica Santiago
      • Spartanburg, South Carolina, Forente stater, 29301
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Christopher Davis
    • Tennessee
      • Knoxville, Tennessee, Forente stater, 37909
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Amanda Miller
      • Knoxville, Tennessee, Forente stater, 37912
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Paul Wakefield
    • Texas
      • Austin, Texas, Forente stater, 78704
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Timothy Vachris
      • Austin, Texas, Forente stater, 78705-3214
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Cary Douglass
      • Brownsville, Texas, Forente stater, 78526
        • Rekruttering
        • GSK Investigational Site
        • Hovedetterforsker:
          • Christopher Romero
        • Ta kontakt med:
        • Ta kontakt med:
      • Carrollton, Texas, Forente stater, 75006-2139
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Andrea Brown
      • Cypress, Texas, Forente stater, 77429
        • Rekruttering
        • GSK Investigational Site
        • Hovedetterforsker:
          • Dileep Puppala
        • Ta kontakt med:
        • Ta kontakt med:
      • Dallas, Texas, Forente stater, 75230
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Bachar Elsaadi
      • Dallas, Texas, Forente stater, 75243-1921
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Valentine Ebuh
      • DeSoto, Texas, Forente stater, 75115
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Haresh Boghara
      • Edinburg, Texas, Forente stater, 78539-3432
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • German Esquivel
      • El Paso, Texas, Forente stater, 79902
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jose Burgos
      • Fort Worth, Texas, Forente stater, 76135
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • William Seger
      • Friendswood, Texas, Forente stater, 77546
        • Rekruttering
        • GSK Investigational Site
        • Hovedetterforsker:
          • Efrain Soto
        • Ta kontakt med:
        • Ta kontakt med:
      • Garland, Texas, Forente stater, 75043
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Laquita Shepherd
      • Houston, Texas, Forente stater, 77065
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Tiffany Huynh
      • Houston, Texas, Forente stater, 77087
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Yuliet Mora
      • Houston, Texas, Forente stater, 77008
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Van Tran
      • Houston, Texas, Forente stater, 77081
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Brandon Essink
      • Houston, Texas, Forente stater, 77040
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Damaris Vega
      • Irving, Texas, Forente stater, 75061
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Danielle Coulter
      • Keller, Texas, Forente stater, 76248
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Gregory Fuller
      • Laredo, Texas, Forente stater, 78041
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jose Garcia
      • McKinney, Texas, Forente stater, 75071
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Asad Karim
      • Mesquite, Texas, Forente stater, 75149
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Salma Saiger
      • Pearland, Texas, Forente stater, 77584
        • Rekruttering
        • GSK Investigational Site
        • Hovedetterforsker:
          • Murtaza Mussaji
        • Ta kontakt med:
        • Ta kontakt med:
      • Plano, Texas, Forente stater, 75093
        • Rekruttering
        • GSK Investigational Site
        • Hovedetterforsker:
          • Michele Reynolds
        • Ta kontakt med:
        • Ta kontakt med:
      • San Antonio, Texas, Forente stater, 78527
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Rashid Atique
      • Stephenville, Texas, Forente stater, 76401
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Benjamin Marcum
      • The Woodlands, Texas, Forente stater, 77384
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Clifford Yut
    • Utah
      • Salt Lake City, Utah, Forente stater, 84107
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Todd Bertoch
      • South Ogden, Utah, Forente stater, 84405-4869
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • John Hemmersmeier
      • West Jordan, Utah, Forente stater, 84088
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Barbara Rizzardi
    • Virginia
      • Charlottesville, Virginia, Forente stater, 22911
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • James Clark
      • Newport News, Virginia, Forente stater, 23606
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • George Freeman
      • Norfolk, Virginia, Forente stater, 23502-3931
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Marc Gaines
      • Richmond, Virginia, Forente stater, 23226
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Leroy Vaughan
    • Washington
      • Renton, Washington, Forente stater, 98057
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Sheryl Marks
      • Seattle, Washington, Forente stater, 98104-2725
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Rebecca Dunsmoor-Su

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

  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

Inclusion Criteria:

  1. Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol independently or with the assistance of a caregiver.
  2. Written or witnessed (physically or digitally) informed consent obtained from the participant/Legally acceptable representative [LAR(s)] of the participant prior to performance of any study-specific procedure.
  3. Healthy participants or medically stable patients as established by medical history and clinical examination. Participants with chronic medical conditions with or without specific treatment are allowed to participate in this study if considered by the investigator as medically stable. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during 3 months before enrollment.
  4. A male or female participant at least 65 YOA at the time of the study intervention administration.

Exclusion Criteria:

  1. History of test-confirmed influenza infection within 180 days prior to study intervention administration.
  2. Any confirmed or suspected immunosuppressive or immunodeficient condition. HIV-infected individuals may be enrolled if they have been stable on antiretroviral therapy for the past 6 consecutive months, their CD4 cell count is ≥ 200/mm³ and their viral load has been undetectable.
  3. Hypersensitivity to latex.
  4. History of myocarditis or pericarditis considered causally associated with mRNA vaccine.
  5. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
  6. History of hypersensitivity or allergic reaction to any previous influenza vaccine.
  7. History of hypersensitivity or allergic reaction to any previous mRNA vaccine.
  8. History of Guillain-Barré syndrome (GBS) within 6 weeks of receiving any vaccine.
  9. Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study
  10. Acute or unstable chronic conditions [clinically significant pulmonary, cardiovascular, hepatic, metabolic/endocrine disorders, renal functional abnormality, or psychiatric conditions], as determined by medical history and clinical examination.
  11. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant, due to participation in the clinical study.
  12. Condition that in the judgment of the investigator would make intramuscular injection unsafe.
  13. Administration of an influenza vaccine in the period starting 180 days before the study intervention administration or planned administration at any time during the study.
  14. Planned administration/administration of any mRNA-based vaccine, live vaccine or adjuvanted protein-based vaccine in the period starting 30 days before the study intervention administration (Day -29 to Day 1) and ending 28 days after the study intervention administration (Day 1 to Day 28) or a non-replicating vaccine in the period starting 15 days before the study intervention administration (Day -14 to Day 1) and ending 14 days after the study intervention administration (Day 1 to Day 14).
  15. Use of any investigational or non-registered product (drug, vaccine or invasive medical device in the country of enrollment) other than the study intervention during the period beginning 30 days before the dose of study intervention (Day -29 to Day 1), or their planned use during the study period.
  16. Administration of immunoglobulins or other blood products or plasma derivatives during the period starting 90 days before the study intervention (Day -89 to Day 1) or planned administration during the study period.

  17. Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the end of the study.

    • Up to 90 days prior to the study intervention administration:
    • For systemic corticosteroids: prednisone equivalent ≥20 mg/day for >14 days. Inhaled, intra articular/intra-bursal, and topical steroids are allowed.
    • Long-acting immune-modifying drugs including among others immunotherapy (e.g., TNF-inhibitors), monoclonal antibodies, antitumoral medication.
  18. Administration of antitumoral medication during the period starting 90 days before the study intervention (Day -89 to Day 1) or planned administration during the study period.
  19. Administration of any vaccine in a clinical trial investigating an influenza mRNA vaccine in the period starting 1 year before the study intervention administration.
  20. Concurrently participating in another clinical study at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device).
  21. For enrollment in Season 2: Previous participation (i.e., during previous season) in this clinical study.
  22. Planned move during the study period that will prohibit participating in the study until study end.
  23. Planned leave or holiday of 4 consecutive weeks or more during the influenza season covered by the study, that would prohibit the reporting of ILI cases and attendance to ILI visit.
  24. Any study personnel or their immediate dependents, family, or household members.

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: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: mRNA Seasonal Flu Vaccine
Participants will receive a single dose of investigational mRNA Seasonal Flu vaccine on Day 1.
Kombinasjonsprodukt: mRNA Seasonal Flu vaccine
Single-dose intramuscular administration of the season-adapted investigational mRNA Seasonal Flu vaccine.
Aktiv komparator: Active Comparator
Participants will receive a single dose of an age-appropriate and season-adapted licensed influenza vaccine Day 1.
Kombinasjonsprodukt: Licensed Influenza Vaccine
Single-dose intramuscular administration of an age-appropriate and season-adapted licensed influenza vaccine used as the active comparator.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Antall deltakere med anmodet systemisk AES
Tidsramme: Fra dag 1 til dag 7
Den anmodede systemiske AE -ene som er vurdert er feber, hodepine, tretthet, myalgi, arthralygia og frysninger. Feber er definert som temperatur større enn eller lik (> =) 38 ° C/100.4 ° F Uansett målingssted.
Fra dag 1 til dag 7
Antall deltakere med uoppfordret AES
Tidsramme: Fra dag 1 til dag 28
En uoppfordret AE er en AE som enten ikke var inkludert i listen over anmodede hendelser eller kan inkluderes i listen over anmodede hendelser, men med et begynnelse utenfor den spesifiserte perioden med oppfølging for anmodede hendelser.
Fra dag 1 til dag 28
Laboratory-confirmed protocol-defined influenza-like illness (ILI) assessed by incidence rate ratio
Tidsramme: From Day 15 through the end of the influenza Season
First occurrence of laboratory-confirmed protocol-defined ILI caused by influenza A subtypes and B lineage. Protocol-defined ILI is defined as the simultaneous occurrence of at least 1 respiratory symptom and at least 1 systemic symptom. Respiratory symptoms include nasal congestion, sore throat, new or increased sputum, new or increased cough, new or increased dyspnea, or wheezing. Systemic symptoms include temperature >37.2°C/99°F or feverishness, fatigue, myalgia, or headache. The endpoint will be assessed using an incidence rate approach. Relative vaccine efficacy will be calculated as 100 × (1 - incidence rate ratio).
From Day 15 through the end of the influenza Season
Number of Participants with Solicited Administration Site Adverse Events (AEs)
Tidsramme: From Day 1 to Day 7
The solicited administration site AEs considered are pain, redness, swelling and lymphadenopathy. Lymphadenopathy is defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm.
From Day 1 to Day 7
Number of Participants with Serious Adverse Events (SAEs)
Tidsramme: From Day 1 up to the end of the influenza season (with at least 180 days of follow-up)
SAE is an AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or other situations that are considered serious per medical or scientific judgment.
From Day 1 up to the end of the influenza season (with at least 180 days of follow-up)
Number of Participants with Adverse Events of Special Interest (AESIs)
Tidsramme: From Day 1 up to the end of the influenza season (with at least 180 days of follow-up)
An adverse event of special interest is an adverse event of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor may be appropriate. AESIs include protocol-defined events such as potential immune-mediated disorders, myocarditis, pericarditis, severe hypersensitivity reactions, and other AESIs defined in the protocol.
From Day 1 up to the end of the influenza season (with at least 180 days of follow-up)
Number of Participants with any Laboratory abnormalities
Tidsramme: At Day 1 (pre-dose) and at Day 29 (post -dose)
At Day 1 (pre-dose) and at Day 29 (post -dose)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Prosentandel av deltakere med antigen 1 seroproteksjonshastighet (SPR)
Tidsramme: På dag 1 og dag 29
På dag 1 og dag 29
Laboratory-confirmed protocol-defined ILI assessed for relative vaccine efficacy by incidence rate ratio
Tidsramme: From Day 15 through the end of the influenza Season
First occurrence of laboratory-confirmed protocol-defined ILI caused by influenza A subtypes and B lineage. This endpoint will assess the incidence rate of the investigational mRNA Seasonal Flu vaccine compared with the licensed influenza vaccine comparator.
From Day 15 through the end of the influenza Season
Severe Influenza Disease (SID) assessed by incidence rate ratio
Tidsramme: From Day 15 through the end of the influenza Season
First occurrence of severe influenza disease caused by influenza A or B. Severe influenza disease includes serious influenza-related outcomes such as pneumonia, hospitalization, or death associated with laboratory-confirmed influenza.
From Day 15 through the end of the influenza Season
Laboratory-confirmed Centers for Disease Control and Prevention-defined ILI assessed by incidence rate ratio
Tidsramme: From Day 15 through the end of the influenza Season
First occurrence of laboratory-confirmed Centers for Disease Control and Prevention-defined ILI caused by influenza A subtypes and B lineage.
From Day 15 through the end of the influenza Season
Laboratory-confirmed modified Centers for Disease Control and Prevention-defined ILI assessed by incidence rate ratio
Tidsramme: From Day 15 through the end of the influenza Season
First occurrence of laboratory-confirmed modified Centers for Disease Control and Prevention-defined ILI caused by influenza A subtypes and B lineage.
From Day 15 through the end of the influenza Season
Laboratory-confirmed protocol-defined ILI by antigenic matching status
Tidsramme: From Day 15 through the end of the influenza Season ,
First occurrence of laboratory-confirmed protocol-defined ILI caused by influenza viruses considered antigenically matched, non-matched, or of unknown matching status to the vaccine strains.
From Day 15 through the end of the influenza Season ,
All-cause protocol-defined ILI assessed by incidence rate ratio
Tidsramme: From Day 15 through the end of the influenza Season
First occurrence of protocol-defined ILI, regardless of cause.
From Day 15 through the end of the influenza Season
Influenza-related medically attended event assessed by incidence rate ratio
Tidsramme: From Day 15 through the end of the influenza Season
First occurrence of an influenza-related medically attended event associated with laboratory-confirmed protocol-defined ILI or severe influenza disease.
From Day 15 through the end of the influenza Season
Influenza-related oxygen support for more than 24 hours assessed by incidence rate ratio
Tidsramme: From Day 15 through the end of the influenza Season
First occurrence of influenza-related oxygen support for more than 24 hours associated with laboratory-confirmed protocol-defined ILI or severe influenza disease.
From Day 15 through the end of the influenza Season
Influenza-related intensive care unit admission assessed by incidence rate ratio
Tidsramme: From Day 15 through the end of the influenza Season
First occurrence of influenza-related intensive care unit admission associated with laboratory-confirmed protocol-defined ILI or severe influenza disease.
From Day 15 through the end of the influenza Season
Influenza-related major adverse cardiovascular event assessed by incidence rate ratio
Tidsramme: From Day 15 through the end of the influenza Season
First occurrence of influenza-related major adverse cardiovascular event associated with laboratory-confirmed protocol-defined ILI or severe influenza disease.
From Day 15 through the end of the influenza Season
To evaluate the impact of the study interventions on healthcare resource utilization during laboratory-confirmed influenza episodes
Tidsramme: From Day 15 through the end of the influenza Season
Healthcare resource utilization during laboratory-confirmed protocol-defined ILI or severe influenza disease episodes. This includes hospitalization and length of stay, intensive care unit admission and length of stay, emergency room or urgent care visits, general practitioner or specialist visits, medical home visits, physical therapy sessions, use of antibiotics, antiviral medication, oxygen therapy, advanced oxygen support, mechanical ventilation, and number of days missed from work.
From Day 15 through the end of the influenza Season
Geometric mean titers (GMT) Ratio of Antigen 1, Antigen 2 and Virus Neutralization Antibody Titers
Tidsramme: At Day 29
At Day 29
Geometric mean increase (GMI) of Antigen 1, Antigen 2 and Virus Neutralization Antibody Titers
Tidsramme: From Day 1 to Day 29
From Day 1 to Day 29
Percentage of Participants with Antigen 1, Antigen 2 and Virus Neutralization Seroconversion Rate (SCR)
Tidsramme: From Day 1 to Day 29
From Day 1 to Day 29

Samarbeidspartnere og etterforskere

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

Sponsor

GlaxoSmithKline

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)

2. september 2026

Primær fullføring (Antatt)

9. juni 2028

Studiet fullført (Antatt)

9. juni 2028

Datoer for studieregistrering

Først innsendt

1. september 2026

Først innsendt som oppfylte QC-kriteriene

1. september 2026

Først lagt ut (Faktiske)

4. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 218130
  • 2026-526682-14 (Annen identifikator: EU CT Number)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf

IPD-delingstidsramme

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.

Tilgangskriterier for IPD-deling

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • CSR

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