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A Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an Adjuvanted Influenza Vaccine Compared to a Non-adjuvanted Influenza Vaccine in Adults ≥65 Years of Age
Sponsor: Seqirus
Summary
This Phase 3 study is a randomized, observer-blind study of MF59-adjuvanted influenza vaccine (aQIV or aTIV) compared with a non-adjuvanted influenza vaccine (QIV or TIV) in adults ≥65 years of age. The aim of the study is to evaluate MF59-adjuvanted influenza vaccine compared with non-adjuvanted influenza vaccine in the prevention of reverse transcription-polymerase chain reaction (RT-PCR)-confirmed influenza A and/or B in subjects ≥65 years of age.
Official title: A Phase 3/3b, Randomized, Observer-blind, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of Fluad and Fluad Quadrivalent Compared to a Non-adjuvanted Influenza Vaccine in Adults ≥65 Years of Age
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
38769
Start Date
2023-10-23
Completion Date
2026-06-15
Last Updated
2026-09-02
Healthy Volunteers
Yes
Conditions
Interventions
aQIV or aTIV
Participants receive a 0.5-mL intramuscular dose of aQIV or aTIV on Day 1. A 0.5 mL dose of aQIV contains nominally 15 µg of hemagglutinin (HA) of each of the 2 influenza type A strains and each of the 2 influenza B strains (total of 60 µg HA). A 0.5 mL dose of aTIV contains nominally 15 µg of HA of each of the 2 influenza type A strains and of the influenza B strain (total of 45 µg HA). The strain composition of aQIV and aTIV is that recommended by the World Health Organization (WHO) for quadrivalent and trivalent influenza vaccines, respectively, contemporaneous to the timing of the study.
QIV or TIV
Participants receive a 0.5-mL intramuscular dose of the non-adjuvanted QIV or TIV on Day 1. A 0.5 mL dose of QIV contains nominally 15 μg of HA of each of the 2 influenza type A strains and each of the 2 influenza B strains (total of 60 μg HA). A 0.5 mL dose of TIV contains nominally 15 μg of HA of each of the 2 influenza type A strains and of the influenza B strain (total of 45 μg HA). The strain composition of QIV and TIV is that recommended by the WHO for quadrivalent and trivalent influenza vaccines, respectively, contemporaneous to the timing of the study.
Locations (255)
84046-Accel Research Sites - Birmingham
Birmingham, Alabama, United States
84075-Cullman Clinical Trials
Cullman, Alabama, United States
84112-DM Clinical Research - Phoenix
Phoenix, Arizona, United States
84114-Scottsdale Clinical Trials
Scottsdale, Arizona, United States
84045-Lynn Institute of the Ozarks
Little Rock, Arkansas, United States
84070-Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States
84101-West Coast Research LLC
Dublin, California, United States
84124-Leading Edge Research
Encino, California, United States
84104-Zillan Clinical Research
Inglewood, California, United States
84105-Eximia Research - CA
La Mesa, California, United States
84107-Long Beach Research Institute
Long Beach, California, United States
84109-Long Beach Clinical Trials
Long Beach, California, United States
84115-Central Valley Research
Modesto, California, United States
84120-Paradigm Research
Redding, California, United States
84119-Apex Clinical Research
San Diego, California, United States
84125-Lynn Institute of Denver
Aurora, Colorado, United States
84110-Tekton Research
Longmont, Colorado, United States
84123-Paradigm Research
Wheat Ridge, Colorado, United States
84085-Clinical Research Consulting, LLC
Milford, Connecticut, United States
84017-Chase Medical Research, LLC
Waterbury, Connecticut, United States
84029-Imagine Research of Palm Beach County
Boynton Beach, Florida, United States
84067-Innovative Research of West Florida, Inc.
Clearwater, Florida, United States
84006-Nature Coast Clinical Research - Crystal River
Crystal River, Florida, United States
84016-USA and International Research Inc.
Doral, Florida, United States
84061-Velocity Clinical Research - New Smyrna Beach
Edgewater, Florida, United States
84065-Fleming Island Center for Clinical Research
Fleming Island, Florida, United States
84027-SIMEDHealth, LLC
Gainesville, Florida, United States
84019-Green Leaf Clinical Trials
Jacksonville, Florida, United States
84026-Health Awareness, Inc.
Jupiter, Florida, United States
84071-3SYNC Research
Lake Worth, Florida, United States
84083-Accel Research Sites Network - St. Petersburg-Largo
Largo, Florida, United States
84012-Evolution Clinical Trials
Miami, Florida, United States
84082-Global Health Research Center, Inc.
Miami Lakes, Florida, United States
84081-Suncoast Research Associates, LLC
Pembroke Pines, Florida, United States
84024-St. Johns Center for Clinical Research
Saint Augustine, Florida, United States
84051-Precision Clinical Research
Sunrise, Florida, United States
84008-Global Health Research Center, Inc. - Tampa
Tampa, Florida, United States
84037-Eximia Research - GA
Atlanta, Georgia, United States
84086-Agile Clinical Research Trials, LLC
Atlanta, Georgia, United States
84054-Centricity Research Columbus
Columbus, Georgia, United States
84013-M3 Wake Research/Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, United States
84069-Velocity Clinical Research - Savannah
Savannah, Georgia, United States
84039-North Georgia Clinical Research
Woodstock, Georgia, United States
84118-Velocity Clinical Research - Boise
Meridian, Idaho, United States
84060-Great Lakes Clinical Trials LLC, dba Flourish Research
Chicago, Illinois, United States
84022-DM Clinical Research - River Forest
Melrose Park, Illinois, United States
84025-Velocity Clinical Research - Valparaiso
Valparaiso, Indiana, United States
84042-Velocity Clinical Research - Sioux City
Sioux City, Iowa, United States
84055-Velocity Clinical Research - Baton Rouge
Baton Rouge, Louisiana, United States
84088-Velocity Clinical Research - Covington
Covington, Louisiana, United States
84052-Velocity Clinical Research - Lafayette
Lafayette, Louisiana, United States
84064-Benchmark Research
Metairie, Louisiana, United States
84005-DM Clinical Research - Brookline
Brookline, Massachusetts, United States
84002-ActivMed Practices and Research, LLC
Methuen, Massachusetts, United States
84044-Clarkston Medical Group
Clarkston, Michigan, United States
84018-Quest Research Institute
Farmington Hills, Michigan, United States
84032-Bioscope Clinical Research, LLC
Farmington Hills, Michigan, United States
84001-Revival Research Institute, LLC
Southfield, Michigan, United States
84074-DM Clinical Research - Southfield
Southfield, Michigan, United States
84023-Velocity Clinical Research - Gulfport
Gulfport, Mississippi, United States
84038-Kansas City Research Institute
Kansas City, Missouri, United States
84057-Sundance Clinical Research
St Louis, Missouri, United States
84108-Boeson Research MSO
Missoula, Montana, United States
84030-Velocity Clinical Research - Grand Island
Grand Island, Nebraska, United States
84040-Velocity Clinical Research - Norfolk
Norfolk, Nebraska, United States
84007-Velocity Clinical Research - Omaha
Omaha, Nebraska, United States
84117-M3 Wake Research/CRCN
Las Vegas, Nevada, United States
84103-Alliance for Multispecialty Research, LLC
Las Vegas, Nevada, United States
84111-Vector Clinical Trials
Las Vegas, Nevada, United States
84106-Las Vegas Clinical Trials
North Las Vegas, Nevada, United States
84003-DM Clinical Research - New Jersey
Jersey City, New Jersey, United States
84122-Albuquerque Clinical Trials
Albuquerque, New Mexico, United States
84048-Velocity Clinical Research - Binghamton
Binghamton, New York, United States
84077-Velocity Clinical Research - Syracuse
East Syracuse, New York, United States
84014-Asheville Clinical Research
Asheville, North Carolina, United States
84089-Velocity Clinical Research - Durham
Durham, North Carolina, United States
84035-Monroe Biomedical Research
Monroe, North Carolina, United States
84102-Eximia Research - NC
Raleigh, North Carolina, United States
84020-M3 Wake Research/Raleigh Clinical Research, LLC
Raleigh, North Carolina, United States
84004-TMA Headlands LLC, dba Trial Management Associates
Wilmington, North Carolina, United States
84079-Progressive Medicine of the Triad, LLC
Winston-Salem, North Carolina, United States
84021-Velocity Clinical Research - Cleveland
Beachwood, Ohio, United States
84034-CTI Clinical Research Center
Cincinnati, Ohio, United States
84063-Velocity Clinical Research - Cincinnati (Mt. Auburn)
Cincinnati, Ohio, United States
84078-Tekton Research
Yukon, Oklahoma, United States
84121-Velocity Clinical Research - Medford
Medford, Oregon, United States
84050-3SYNC Research
Pittsburgh, Pennsylvania, United States
84009-Velocity Clinical Research - Providence
East Greenwich, Rhode Island, United States
84010-M3 Wake Research/Charleston Clinical Trials, LLC
Charleston, South Carolina, United States
84043-Velocity Clinical Research - Gaffney
Gaffney, South Carolina, United States
84056-Coastal Carolina Research Center, LLC
North Charleston, South Carolina, United States
84047-Velocity Clinical Research - Spartanburg
Spartanburg, South Carolina, United States
84053-Velocity Clinical Research - Union
Union, South Carolina, United States
84068-WR-ClinSearch, LLC
Chattanooga, Tennessee, United States
84090-Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, United States
84084-Clinical Research Associates, Inc.
Nashville, Tennessee, United States
84072-WR-Global Medical Research, LLC
Dallas, Texas, United States
84028-Benchmark Research
Fort Worth, Texas, United States
84015-Trio Clinical Trials LLC
Houston, Texas, United States
84062-Activian Clinical Research
Kingwood, Texas, United States