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

17 septembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

54000

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • États-Unis
    • Alabama
      • Anniston, Alabama, États-Unis, 36207
        • Recrutement
        • GSK Investigational Site
        • Chercheur principal:
          • Almena Free
        • Contact:
        • Contact:
      • Guntersville, Alabama, États-Unis, 35976-2206
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • William A Nixon
    • Arizona
      • Glendale, Arizona, États-Unis, 85308
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Abram Burgher
      • Mesa, Arizona, États-Unis, 85206
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Tami Bruce
      • Mesa, Arizona, États-Unis, 85213
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • David Shockey
      • Phoenix, Arizona, États-Unis, 85032
        • Recrutement
        • GSK Investigational Site
        • Chercheur principal:
          • Matthew Doust
        • Contact:
        • Contact:
      • Phoenix, Arizona, États-Unis, 85014
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Brock Merritt
      • Scottsdale, Arizona, États-Unis, 85250
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Ben Clark
      • Scottsdale, Arizona, États-Unis, 85255
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Steven Siwek
      • Sun City, Arizona, États-Unis, 85351-2146
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Rachel Greatwood
      • Tempe, Arizona, États-Unis, 85284
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Joseph Davis
      • Tempe, Arizona, États-Unis, 85283-1527
        • Recrutement
        • GSK Investigational Site
        • Chercheur principal:
          • Thomas Fiel
        • Contact:
        • Contact:
      • Tucson, Arizona, États-Unis, 85712
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Girish Karamchandani
      • Tucson, Arizona, États-Unis, 85711
        • Recrutement
        • GSK Investigational Site
        • Chercheur principal:
          • Anita Kohli
        • Contact:
        • Contact:
    • Arkansas
      • Little Rock, Arkansas, États-Unis, 72205
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Priyantha Wijewardane
      • Little Rock, Arkansas, États-Unis, 72204
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Derek Lewis
    • California
      • Dublin, California, États-Unis, 94568-2453
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Alfred Tan
      • Escondido, California, États-Unis, 92025
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Vicki Miller
      • Fair Oaks, California, États-Unis, 95628
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Masaru Oshita
      • La Palma, California, États-Unis, 90623
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Andrew Morado
      • Redding, California, États-Unis, 96001
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Rafael Lupercio
      • Riverside, California, États-Unis, 92503
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Jack Vu
      • Rolling Hills Estates, California, États-Unis, 90274-3664
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Lawrence Sher
      • San Bernardino, California, États-Unis, 92408
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Judith Kirstein
      • San Diego, California, États-Unis, 92103
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Stacey Layle
      • Walnut Creek, California, États-Unis, 94598
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Helen Stacey
    • Colorado
      • Aurora, Colorado, États-Unis, 80012
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Timothy Colander
      • Colorado Springs, Colorado, États-Unis, 80909
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Charles Bird
    • Connecticut
      • Stamford, Connecticut, États-Unis, 06905
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • David Radin
      • Waterbury, Connecticut, États-Unis, 06708
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Joseph Soufer
    • Florida
      • Altamonte Springs, Florida, États-Unis, 32701
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Andrew Feldman
      • Fort Lauderdale, Florida, États-Unis, 33308
        • Recrutement
        • GSK Investigational Site
        • Chercheur principal:
          • David Mishkin
        • Contact:
        • Contact:
      • Hialeah, Florida, États-Unis, 33012
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Wilson Cueva
      • Hialeah, Florida, États-Unis, 33016
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Gustavo Ledo Sanchez
      • Homestead, Florida, États-Unis, 33030
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Julio Valdes-Liste
      • Lake Mary, Florida, États-Unis, 32720
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Bruce Rankin
      • Lake Worth, Florida, États-Unis, 33462
        • Recrutement
        • GSK Investigational Site
        • Chercheur principal:
          • David Halpert
        • Contact:
        • Contact:
      • Maitland, Florida, États-Unis, 32751
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Theodore Lee
      • Melbourne, Florida, États-Unis, 32934-8172
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Murray Kimmel
      • Miami, Florida, États-Unis, 33125
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Pedro San Martin Parra
      • Miami, Florida, États-Unis, 33186
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Rafael Ubeda
      • Miami, Florida, États-Unis, 33174
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Enrique Pelayo
      • Miami, Florida, États-Unis, 33134
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Gerard Acloque, Jr.
      • Miami, Florida, États-Unis, 33176
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Orlando Puente
      • Miami, Florida, États-Unis, 33135
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Omar Benitez
      • Miami, Florida, États-Unis, 33126-2073
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Ciro Ramirez
      • Miami, Florida, États-Unis, 33130
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Zaid Rana
      • Miami, Florida, États-Unis, 33182-1420
        • Recrutement
        • GSK Investigational Site
        • Chercheur principal:
          • Guillermo Somodevilla
        • Contact:
        • Contact:
      • Miami, Florida, États-Unis, 33276
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Gilberto Jimenez
      • Miami Lakes, Florida, États-Unis, 33016
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Jose Cardona
      • Miami Lakes, Florida, États-Unis, 33016-1597
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Sheila Sanchez
      • Orlando, Florida, États-Unis, 32803
        • Recrutement
        • GSK Investigational Site
        • Chercheur principal:
          • Edgardo Rivera
        • Contact:
        • Contact:
      • Orlando, Florida, États-Unis, 32806
        • Recrutement
        • GSK Investigational Site
        • Chercheur principal:
          • Uzma Khan
        • Contact:
        • Contact:
      • Palmetto Bay, Florida, États-Unis, 33157
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Karen Figueredo Reyes
      • Port Orange, Florida, États-Unis, 32127-5169
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Bhanu Visvalingam
      • Tamarac, Florida, États-Unis, 33321
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Mazyar Rouhani
      • Tampa, Florida, États-Unis, 33614
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Al Robaina
      • Tampa, Florida, États-Unis, 33615
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Daphnee Moise
      • The Villages, Florida, États-Unis, 32162
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Jeffrey Norton
      • West Palm Beach, Florida, États-Unis, 33409
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Mira Baron
    • Georgia
      • Albany, Georgia, États-Unis, 31707
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Charles Kemp
      • Atlanta, Georgia, États-Unis, 30328
        • Recrutement
        • GSK Investigational Site
        • Chercheur principal:
          • Vasundhara Cheekati
        • Contact:
        • Contact:
      • Atlanta, Georgia, États-Unis, 30281
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Jason Agran
      • Decatur, Georgia, États-Unis, 30030
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Ramana Puppala
      • Marietta, Georgia, États-Unis, 30060
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Marvin Tark
      • Riverdale, Georgia, États-Unis, 30274
        • Recrutement
        • GSK Investigational Site
        • Chercheur principal:
          • Deon Miller
        • Contact:
        • Contact:
      • Savannah, Georgia, États-Unis, 31406
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Thomas Moriarity
    • Idaho
      • Meridian, Idaho, États-Unis, 83642-3154
        • Recrutement
        • GSK Investigational Site
        • Chercheur principal:
          • Mark Turner
        • Contact:
        • Contact:
    • Illinois
      • Chicago, Illinois, États-Unis, 60607-4911
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Dennis Levinson
      • Morton, Illinois, États-Unis, 61550
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Stanley Koch
      • Peoria, Illinois, États-Unis, 61614
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Daniel Brune
    • Indiana
      • Valparaiso, Indiana, États-Unis, 46383
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Robert Buynak
    • Kansas
      • Kansas City, Kansas, États-Unis, 66112
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Srinivas Nalamachu
      • Lenexa, Kansas, États-Unis, 66219
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Carlos Fierro
    • Louisiana
      • Lafayette, Louisiana, États-Unis, 70508
        • Recrutement
        • GSK Investigational Site
        • Chercheur principal:
          • Jibran Atwi
        • Contact:
        • Contact:
      • Metairie, Louisiana, États-Unis, 70006
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • David Dulitz
      • New Orleans, Louisiana, États-Unis, 70115
        • Recrutement
        • GSK Investigational Site
        • Chercheur principal:
          • Patrick Dennis
        • Contact:
        • Contact:
    • Maryland
      • Baltimore, Maryland, États-Unis, 21208
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Dima Hnoosh
    • Massachusetts
      • Boston, Massachusetts, États-Unis, 02131
        • Recrutement
        • GSK Investigational Site
        • Chercheur principal:
          • Antonio Mendes
        • Contact:
        • Contact:
      • Brookline, Massachusetts, États-Unis, 02446
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • James Katz
    • Michigan
      • Garden City, Michigan, États-Unis, 48135
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Renee Dwaihy
      • Southfield, Michigan, États-Unis, 48075
        • Recrutement
        • GSK Investigational Site
        • Chercheur principal:
          • Abdulhassan Saad
        • Contact:
        • Contact:
      • Southfield, Michigan, États-Unis, 48034
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Diana Carlson
    • Mississippi
      • Gulfport, Mississippi, États-Unis, 39503
        • Recrutement
        • GSK Investigational Site
        • Chercheur principal:
          • Sean Kerby
        • Contact:
        • Contact:
    • Missouri
      • Chesterfield, Missouri, États-Unis, 63005
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Timothy Jennings
      • St Louis, Missouri, États-Unis, 63141
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Larkin Wadsworth
      • St Louis, Missouri, États-Unis, 63141-6282
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Jeffrey Tillinghast
    • Nebraska
      • Elkhorn, Nebraska, États-Unis, 68022
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • William Fitzgibbons
      • Grand Island, Nebraska, États-Unis, 68803
        • Recrutement
        • GSK Investigational Site
        • Chercheur principal:
          • Adam Brosz
        • Contact:
        • Contact:
      • Norfolk, Nebraska, États-Unis, 68701-7701
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Charles Harper
      • Omaha, Nebraska, États-Unis, 68114
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Brian Hollis
    • Nevada
      • Las Vegas, Nevada, États-Unis, 89106
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Stephen Tam
      • Las Vegas, Nevada, États-Unis, 89109
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Robby Quintos
    • New Jersey
      • Warren Township, New Jersey, États-Unis, 07059-2730
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Samar Hameed
    • New Mexico
      • Santa Fe, New Mexico, États-Unis, 87505
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Wendy Johnson
    • New York
      • Hartsdale, New York, États-Unis, 10530
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Michael Gerdis
      • Rochester, New York, États-Unis, 14609
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Patrick Connors
    • North Carolina
      • Charlotte, North Carolina, États-Unis, 28210
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Christina Kennelly
      • Denver, North Carolina, États-Unis, 80110
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Robert Williams
      • Durham, North Carolina, États-Unis, 27704
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Sherif Naguib
      • Fayetteville, North Carolina, États-Unis, 30214
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Charlotte Mathis
      • Greensboro, North Carolina, États-Unis, 27408
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Alexander Murray
      • Hickory, North Carolina, États-Unis, 28601
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Scott Polster
      • Raleigh, North Carolina, États-Unis, 27527
        • Recrutement
        • GSK Investigational Site
        • Chercheur principal:
          • Matthew Hong
        • Contact:
        • Contact:
      • Salisbury, North Carolina, États-Unis, 28144
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Kishan Maramraj
      • Wilmington, North Carolina, États-Unis, 28403
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Barton Williams
      • Winston-Salem, North Carolina, États-Unis, 27103
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Jonathan Wilson
    • Ohio
      • Blue Ash, Ohio, États-Unis, 45242-3763
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Audrius Ruksenas
      • Cincinnati, Ohio, États-Unis, 45246
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Charles Eger
      • Columbus, Ohio, États-Unis, 43213
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Sridhar Guduri
      • Lima, Ohio, États-Unis, 45801
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Nonso Ezema
    • Oklahoma
      • Chickasha, Oklahoma, États-Unis, 73018-2738
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Ahmad Musa
      • Oklahoma City, Oklahoma, États-Unis, 73111
        • Recrutement
        • GSK Investigational Site
        • Chercheur principal:
          • Carl Griffin
        • Contact:
        • Contact:
      • Tulsa, Oklahoma, États-Unis, 74133
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Melita Tate
    • Oregon
      • Portland, Oregon, États-Unis, 97210-5311
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Andre Barkhuizen
    • Pennsylvania
      • Camp Hill, Pennsylvania, États-Unis, 17011
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Venkatesh Nadar
      • Philadelphia, Pennsylvania, États-Unis, 19107
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • David Wheeler
    • South Carolina
      • Anderson, South Carolina, États-Unis, 29621-4822
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Daniel Williams
      • Little River, South Carolina, États-Unis, 29569
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Stephen Grubb
      • Myrtle Beach, South Carolina, États-Unis, 29572
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Donald Eagerton
      • North Charleston, South Carolina, États-Unis, 29405
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Rica Santiago
      • Spartanburg, South Carolina, États-Unis, 29301
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Christopher Davis
    • Tennessee
      • Knoxville, Tennessee, États-Unis, 37909
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Amanda Miller
      • Knoxville, Tennessee, États-Unis, 37912
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Paul Wakefield
    • Texas
      • Austin, Texas, États-Unis, 78704
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Timothy Vachris
      • Austin, Texas, États-Unis, 78705-3214
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Cary Douglass
      • Brownsville, Texas, États-Unis, 78526
        • Recrutement
        • GSK Investigational Site
        • Chercheur principal:
          • Christopher Romero
        • Contact:
        • Contact:
      • Carrollton, Texas, États-Unis, 75006-2139
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Andrea Brown
      • Cypress, Texas, États-Unis, 77429
        • Recrutement
        • GSK Investigational Site
        • Chercheur principal:
          • Dileep Puppala
        • Contact:
        • Contact:
      • Dallas, Texas, États-Unis, 75230
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Bachar Elsaadi
      • Dallas, Texas, États-Unis, 75243-1921
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Valentine Ebuh
      • DeSoto, Texas, États-Unis, 75115
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Haresh Boghara
      • Edinburg, Texas, États-Unis, 78539-3432
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • German Esquivel
      • El Paso, Texas, États-Unis, 79902
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Jose Burgos
      • Fort Worth, Texas, États-Unis, 76135
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • William Seger
      • Friendswood, Texas, États-Unis, 77546
        • Recrutement
        • GSK Investigational Site
        • Chercheur principal:
          • Efrain Soto
        • Contact:
        • Contact:
      • Garland, Texas, États-Unis, 75043
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Laquita Shepherd
      • Houston, Texas, États-Unis, 77065
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Tiffany Huynh
      • Houston, Texas, États-Unis, 77087
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Yuliet Mora
      • Houston, Texas, États-Unis, 77008
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Van Tran
      • Houston, Texas, États-Unis, 77081
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Brandon Essink
      • Houston, Texas, États-Unis, 77040
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Damaris Vega
      • Irving, Texas, États-Unis, 75061
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Danielle Coulter
      • Keller, Texas, États-Unis, 76248
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Gregory Fuller
      • Laredo, Texas, États-Unis, 78041
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Jose Garcia
      • McKinney, Texas, États-Unis, 75071
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Asad Karim
      • Mesquite, Texas, États-Unis, 75149
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Salma Saiger
      • Pearland, Texas, États-Unis, 77584
        • Recrutement
        • GSK Investigational Site
        • Chercheur principal:
          • Murtaza Mussaji
        • Contact:
        • Contact:
      • Plano, Texas, États-Unis, 75093
        • Recrutement
        • GSK Investigational Site
        • Chercheur principal:
          • Michele Reynolds
        • Contact:
        • Contact:
      • San Antonio, Texas, États-Unis, 78527
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Rashid Atique
      • Stephenville, Texas, États-Unis, 76401
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Benjamin Marcum
      • The Woodlands, Texas, États-Unis, 77384
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Clifford Yut
    • Utah
      • Salt Lake City, Utah, États-Unis, 84107
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Todd Bertoch
      • South Ogden, Utah, États-Unis, 84405-4869
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • John Hemmersmeier
      • West Jordan, Utah, États-Unis, 84088
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Barbara Rizzardi
    • Virginia
      • Charlottesville, Virginia, États-Unis, 22911
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • James Clark
      • Newport News, Virginia, États-Unis, 23606
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • George Freeman
      • Norfolk, Virginia, États-Unis, 23502-3931
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Marc Gaines
      • Richmond, Virginia, États-Unis, 23226
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Leroy Vaughan
    • Washington
      • Renton, Washington, États-Unis, 98057
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Sheryl Marks
      • Seattle, Washington, États-Unis, 98104-2725
        • Recrutement
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Chercheur principal:
          • Rebecca Dunsmoor-Su

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte plus âgé

Accepte les volontaires sains

Oui

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: mRNA Seasonal Flu Vaccine
Participants will receive a single dose of investigational mRNA Seasonal Flu vaccine on Day 1.
Produit combiné: mRNA Seasonal Flu vaccine
Single-dose intramuscular administration of the season-adapted investigational mRNA Seasonal Flu vaccine.
Comparateur actif: Active Comparator
Participants will receive a single dose of an age-appropriate and season-adapted licensed influenza vaccine Day 1.
Produit combiné: Licensed Influenza Vaccine
Single-dose intramuscular administration of an age-appropriate and season-adapted licensed influenza vaccine used as the active comparator.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Nombre de participants avec des EI systémiques sollicités
Délai: Du jour 1 au jour 7
Les EI systémiques sollicités considérés sont la fièvre, les maux de tête, la fatigue, la myalgie, l'arthralgie et les frissons. La fièvre est définie comme une température supérieure ou égale à (> =) 38 ° C / 100,4 ° F Indépendamment de l'emplacement de la mesure.
Du jour 1 au jour 7
Nombre de participants avec AES non sollicités
Délai: Du jour 1 au jour 28
Un AE non sollicité est un AE qui n'était pas inclus dans la liste des événements sollicités ou pourrait être inclus dans la liste des événements sollicités mais avec un début en dehors de la période de suivi spécifiée pour les événements sollicités.
Du jour 1 au jour 28
Laboratory-confirmed protocol-defined influenza-like illness (ILI) assessed by incidence rate ratio
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: At Day 1 (pre-dose) and at Day 29 (post -dose)
At Day 1 (pre-dose) and at Day 29 (post -dose)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Pourcentage de participants atteints de taux de séroprotection de l'antigène 1 (SPR)
Délai: Au jour 1 et jour 29
Au jour 1 et jour 29
Laboratory-confirmed protocol-defined ILI assessed for relative vaccine efficacy by incidence rate ratio
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: At Day 29
At Day 29
Geometric mean increase (GMI) of Antigen 1, Antigen 2 and Virus Neutralization Antibody Titers
Délai: 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)
Délai: From Day 1 to Day 29
From Day 1 to Day 29

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

GlaxoSmithKline

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

2 septembre 2026

Achèvement primaire (Estimé)

9 juin 2028

Achèvement de l'étude (Estimé)

9 juin 2028

Dates d'inscription aux études

Première soumission

1 septembre 2026

Première soumission répondant aux critères de contrôle qualité

1 septembre 2026

Première publication (Réel)

4 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 218130
  • 2026-526682-14 (Autre identifiant: EU CT Number)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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

Délai de partage IPD

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.

Critères d'accès au partage IPD

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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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