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

17 de septiembre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

54000

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: mRNA Seasonal Flu Vaccine
Participants will receive a single dose of investigational mRNA Seasonal Flu vaccine on Day 1.
Producto combinado: mRNA Seasonal Flu vaccine
Single-dose intramuscular administration of the season-adapted investigational mRNA Seasonal Flu vaccine.
Comparador activo: Active Comparator
Participants will receive a single dose of an age-appropriate and season-adapted licensed influenza vaccine Day 1.
Producto combinado: Licensed Influenza Vaccine
Single-dose intramuscular administration of an age-appropriate and season-adapted licensed influenza vaccine used as the active comparator.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Número de participantes con AES sistémicos solicitados
Periodo de tiempo: Del día 1 al día 7
Los EA sistémicos solicitados considerados es fiebre, dolor de cabeza, fatiga, mialgia, artralgia y escalofríos. La fiebre se define como una temperatura mayor o igual a (> =) 38 ° C/100.4 ° F independientemente de la ubicación de la medición.
Del día 1 al día 7
Número de participantes con AES no solicitados
Periodo de tiempo: Del día 1 al día 28
Un AE no solicitado es un AE que no estaba incluido en la lista de eventos solicitados o podría incluirse en la lista de eventos solicitados, pero con un inicio fuera del período especificado de seguimiento para eventos solicitados.
Del día 1 al día 28
Laboratory-confirmed protocol-defined influenza-like illness (ILI) assessed by incidence rate ratio
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: At Day 1 (pre-dose) and at Day 29 (post -dose)
At Day 1 (pre-dose) and at Day 29 (post -dose)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Porcentaje de participantes con tasa de seroprotección antígeno 1 (SPR)
Periodo de tiempo: En el día 1 y día 29
En el día 1 y día 29
Laboratory-confirmed protocol-defined ILI assessed for relative vaccine efficacy by incidence rate ratio
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: At Day 29
At Day 29
Geometric mean increase (GMI) of Antigen 1, Antigen 2 and Virus Neutralization Antibody Titers
Periodo de tiempo: 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)
Periodo de tiempo: From Day 1 to Day 29
From Day 1 to Day 29

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

GlaxoSmithKline

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

2 de septiembre de 2026

Finalización primaria (Estimado)

9 de junio de 2028

Finalización del estudio (Estimado)

9 de junio de 2028

Fechas de registro del estudio

Enviado por primera vez

1 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

1 de septiembre de 2026

Publicado por primera vez (Actual)

4 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

17 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 218130
  • 2026-526682-14 (Otro identificador: EU CT Number)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan 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

Marco de tiempo para compartir 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.

Criterios de acceso compartido de 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.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF
  • RSC

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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