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

17. september 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

54000

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Ældre voksen

Tager imod sunde 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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: mRNA Seasonal Flu Vaccine
Participants will receive a single dose of investigational mRNA Seasonal Flu vaccine on Day 1.
Kombinationsprodukt: 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.
Kombinationsprodukt: Licensed Influenza Vaccine
Single-dose intramuscular administration of an age-appropriate and season-adapted licensed influenza vaccine used as the active comparator.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Antal deltagere med anmodet systemiske AE'er
Tidsramme: Fra dag 1 til dag 7
De anmodede systemiske AE'er, der er overvejet, er feber, hovedpine, træthed, myalgi, arthralgi og kulderystelser. Feber defineres som temperatur større end eller lig med (> =) 38 ° C/100.4 ° f uanset målingens placering.
Fra dag 1 til dag 7
Antal deltagere med uopfordrede AE'er
Tidsramme: Fra dag 1 til dag 28
En uopfordret AE er en AE, der enten ikke var inkluderet på listen over anmodede begivenheder eller kunne inkluderes på listen over anmodede begivenheder, men med en begyndelse uden for den specificerede opfølgningsperiode for anmodede begivenheder.
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
Foranstaltningsbeskrivelse
Tidsramme
Procentdel af deltagere med antigen 1 seroprotection hastighed (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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

GlaxoSmithKline

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. september 2026

Primær færdiggørelse (Anslået)

9. juni 2028

Studieafslutning (Anslået)

9. juni 2028

Datoer for studieregistrering

Først indsendt

1. september 2026

Først indsendt, der opfyldte QC-kriterier

1. september 2026

Først opslået (Faktiske)

4. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (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.

IPD-delingsadgangskriterier

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 Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner