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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

Status: Recruiting
Location: See all (159) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: t
View:

• 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.

• 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.

• 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.

• A male or female participant at least 65 YOA at the time of the study intervention administration.

Locations
United States
Alabama
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Anniston
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Guntersville
Arkansas
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Little Rock
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Little Rock
Arizona
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Glendale
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Mesa
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Mesa
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Phoenix
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Phoenix
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Scottsdale
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Scottsdale
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Sun City
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Tempe
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Tempe
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Tucson
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Tucson
California
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Dublin
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Escondido
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Fair Oaks
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La Palma
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Redding
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Riverside
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Rolling Hills Estates
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San Bernardino
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San Diego
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Walnut Creek
Colorado
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Aurora
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Colorado Springs
Connecticut
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Stamford
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Waterbury
Florida
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Altamonte Springs
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Fort Lauderdale
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Hialeah
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Hialeah
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Homestead
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Lake Mary
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Lake Worth
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Maitland
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Melbourne
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Miami
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Miami
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Miami
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Miami
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Miami
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Miami
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Miami
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Miami
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Miami
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Miami
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Miami Lakes
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Orlando
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Orlando
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Palmetto Bay
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Port Orange
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Tamarac
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Tampa
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Tampa
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The Villages
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West Palm Beach
Georgia
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Albany
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Atlanta
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Atlanta
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Decatur
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Marietta
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Riverdale
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Savannah
Idaho
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Meridian
Illinois
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Chicago
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Morton
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Peoria
Indiana
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Valparaiso
Kansas
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Kansas City
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Lenexa
Louisiana
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Lafayette
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Metairie
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New Orleans
Massachusetts
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Boston
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Brookline
Maryland
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Baltimore
Michigan
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Garden City
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Southfield
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Southfield
Missouri
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Chesterfield
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St Louis
Mississippi
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Gulfport
North Carolina
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Charlotte
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Denver
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Durham
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Fayetteville
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Greensboro
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Hickory
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Raleigh
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Salisbury
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Wilmington
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Winston-salem
Nebraska
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Elkhorn
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Grand Island
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Norfolk
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Omaha
New Jersey
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Warren Township
New Mexico
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Santa Fe
Nevada
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Las Vegas
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Las Vegas
New York
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Hartsdale
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Rochester
Ohio
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Blue Ash
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Cincinnati
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Columbus
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Lima
Oklahoma
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Chickasha
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Oklahoma City
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Tulsa
Oregon
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Portland
Pennsylvania
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Camp Hill
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Philadelphia
South Carolina
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Anderson
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Little River
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Myrtle Beach
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North Charleston
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Spartanburg
Tennessee
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Knoxville
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Knoxville
Texas
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Austin
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Austin
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Brownsville
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Carrollton
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Cypress
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Dallas
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Dallas
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Desoto
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Edinburg
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El Paso
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Fort Worth
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Friendswood
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Garland
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Houston
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Houston
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Houston
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Houston
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Houston
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Irving
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Keller
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Laredo
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Mckinney
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Mesquite
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Pearland
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Plano
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San Antonio
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Stephenville
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The Woodlands
Utah
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Salt Lake City
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South Ogden
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West Jordan
Virginia
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Charlottesville
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Newport News
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Norfolk
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Richmond
Washington
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Renton
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Seattle
Contact Information
Primary
US GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
877-379-3718
Backup
EU GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
+44 (0) 20 89904466
Time Frame
Start Date: 2026-09-02
Estimated Completion Date: 2028-06-09
Participants
Target number of participants: 54000
Treatments
Experimental: mRNA Seasonal Flu Vaccine
Participants will receive a single dose of investigational mRNA Seasonal Flu vaccine on Day 1.
Active_comparator: Active Comparator
Participants will receive a single dose of an age-appropriate and season-adapted licensed influenza vaccine Day 1.
Related Therapeutic Areas
Sponsors
Leads: GlaxoSmithKline

This content was sourced from clinicaltrials.gov