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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Influenza, Human
• Intervention / Treatment: Biological: aQIV or aTIV; Biological: QIV or TIV

• Study Type: Interventional
• Enrollment (Estimated): 35800
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Birtinya, Australia
    • 03603-University of the Sunshine Coast
  • Blacktown, Australia
    • 03609-Paratus Clinical Western Sydney
  • Botany, Australia
    • 03605-Emeritus Research - Sydney
  • Brookvale, Australia
    • 03614-Northern Beaches Clinical Research
  • Camberwell, Australia
    • 03602-Emeritus Research - Melbourne
  • Darlinghurst, Australia
    • 03615-Momentum Clinical Research Darlinghurst
  • Herston, Australia
    • 03608-Paratus Clinical Brisbane
  • Kanwal, Australia
    • 03610-Paratus Clinical Central Coast
  • Melbourne, Australia
    • 03604-Doherty Clinical Trials Limited
  • Melbourne, Australia
    • 03611-Nucleus Network
  • Morayfield, Australia
    • 03601-University of the Sunshine Coast - Morayfield
  • South Brisbane, Australia
    • 03607-University of the Sunshine Coast - South Bank
  • Taringa, Australia
    • 03613-Momentum Clinical Research Taringa
  • Wollongong, Australia
    • 03612-Wollongong Clinical Reserach
• Belgium
  • Bruges, Belgium
    • 05605-AZ Sint-Jan Brugge-Oostende - Campus Sint-Jan
  • Ghent, Belgium
    • 05602-Universitair Ziekenhuis Gent
  • Gozée, Belgium
    • 05603-Medif BVBA
  • Ieper, Belgium
    • 05601-Jan Yperman Ziekenhuis
• Bulgaria
  • Gabrovo, Bulgaria
    • 10005-MHAT Dr. Tota Venkova
  • Kozloduy, Bulgaria
    • 10018-Medical Center - Zdrave-1
  • Lovech, Bulgaria
    • 10029-Medical Centre Leo Clinic EOOD
  • Montana, Bulgaria
    • 10007-Medical Center Hera EOOD
  • Montana, Bulgaria
    • 10014-Multi-Profile Hospital For Active Treatment Dr. Stamen Iliev AD
  • Pazardzhik, Bulgaria
    • 10032-MHAT Zdrave
  • Pleven, Bulgaria
    • 10019-MC Med Consult Pleven
  • Plovdiv, Bulgaria
    • 10022-Ambulatory Outpatient Medical Practice for First Patient Care Zaprin Pepelov
  • Plovdiv, Bulgaria
    • 10026-Multiprofile Hospital for Active Treatment Sv. Panteleymon - Plovdiv
  • Plovdiv, Bulgaria
    • 10024-UMHAT Pulmed
  • Plovdiv, Bulgaria
    • 10031-Medical Centre Pratia Clinic EOOD
  • Rousse, Bulgaria
    • 10004-Medical Center Prolet EOOD
  • Rousse, Bulgaria
    • 10012-Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov-Ruse EOOD
  • Sevlievo, Bulgaria
    • 10016-Medical Center 1 - Sevlievo EOOD
  • Sliven, Bulgaria
    • 10023-DCC-1 Sliven
  • Sofia, Bulgaria
    • 10006-DCC 22 - Sofia
  • Sofia, Bulgaria
    • 10015-Medical Center Hera - Pulmonology Office
  • Sofia, Bulgaria
    • 10021-Medical Center Intermedica
  • Sofia, Bulgaria
    • 10028-Medical Center Excelsior OOD
  • Sofia, Bulgaria
    • 10030-Diagnostic-Consultative Centre Ascendent EOOD
  • Stamboliyski, Bulgaria
    • 10027-AIPPMP D-r Zhaneta Demireva
• Czechia
  • Brno, Czechia
    • 20307-CCR Brno s.r.o.
  • Liberec, Czechia
    • 20310-MUDr. Jakub Strincl, s.r.o.
  • Ostrava, Czechia
    • 20309-CCR Ostrava, s.r.o.
  • Protivín, Czechia
    • 20308-MUDr. Jakub Strincl, s.r.o.
  • Přeštice, Czechia
    • 20312-MEDISON s.r.o.
  • České Budějovice, Czechia
    • 20306-ADMED, s.r.o.
  • České Budějovice, Czechia
    • 20305-Centrum ockovani a cestovni mediciny
  • České Budějovice, Czechia
    • 20311-Ordinace Hradebni s.r.o
• Finland
  • Helsinki, Finland
    • 24603-Helsinki South Vaccine Research Clinic
  • Oulu, Finland
    • 24602-Oulu Vaccine Research Clinic
  • Tampere, Finland
    • 24601-Tampere Vaccine Research Clinic
  • Turku, Finland
    • 24604-Turku Vaccine Research Clinic
• Georgia
  • Batumi, Georgia
    • 26803-UNIMED Adjara LTD - Batumi Referral Hospital
  • Kutaisi, Georgia
    • 26801-LTD Hospital Service
  • Tbilisi, Georgia
    • 26802-Acad. G. Chapidze Emergency Cardiology Center
  • Tbilisi, Georgia
    • 26804-K. Eristavi National Center of Clinical Surgery
• Italy
  • Bari, Italy
    • 38003-Policlinico Bari
  • Lecco, Italy
    • 38001-PO A. Manzoni di Lecco, ASST Lecco
  • Milan, Italy
    • 38004-Ospedale Fatebenefratelli e Oftalmico, ASST Fatebenefratelli Sacco
• Lithuania
  • Kaunas, Lithuania
    • 44008-JSC Saulės Šeimos Medicinos Centras
  • Kaunas, Lithuania
    • 44009-Hospital of Lithuanian University of Health Sciences Kauno klinikos
  • Kaunas, Lithuania
    • 44004-JSC InMedica
  • Vilnius, Lithuania
    • 44010-InlitaJSC Santara CTC
• Netherlands
  • Almere Stad, Netherlands
    • 52802-Emotional Brain BV
  • Utrecht, Netherlands
    • 52804-Universitair Medisch Centrum (UMC) Utrecht - Julius Center for Health Sciences and Primary Care
• New Zealand
  • Grafton, New Zealand
    • 55404-Optimal Clinical Trials - Central
  • Mount Cook, New Zealand
    • 55402-Momentum Clinical Research Wellington
  • New Lynn, New Zealand
    • 55405-Pacific Clinical Research Network - West Auckland
  • Rosedale, New Zealand
    • 55403-Optimal Clinical Trials - North
  • Takapuna, New Zealand
    • 55401-PCRN - Auckland
• Philippines
  • Bacoor, Philippines
    • 60812-Health Index Multispecialty and Lying-In Clinic
  • Cebu, Philippines
    • 60813-Norzel Medical and Diagnostic Clinic
  • Dasmariñas, Philippines
    • 60808-CT CARE Group
  • Davao City, Philippines
    • 60801-Davao Doctors Hospital
  • Iloilo City, Philippines
    • 60802-West Visayas State University Medical Center
  • Iloilo City, Philippines
    • 60815-St Paul's Hospital Iloilo
  • Iloilo City, Philippines
    • 60816-St Paul's Hospital Iloilo
  • Manila, Philippines
    • 60803-Philippine General Hospital
  • Manila, Philippines
    • 60811-Philippine General Hospital
  • Manila, Philippines
    • 60814-Manila Doctors Hospital
  • Marilao, Philippines
    • 60804-St. Michael Family Hospital
  • Pasay, Philippines
    • 60805-San Juan de Dios Hospital
  • Quezon City, Philippines
    • 60806-Quirino Memorial Medical Center
  • Silang, Philippines
    • 60817-Silang Specialist Medical Center
• Poland
  • Krakow, Poland
    • 61619-Krakowskie Centrum Medyczne Sp. z o.o
  • Lodz, Poland
    • 61618-Centrum Medyczne AMED Oddzial w Lodzi
  • Lublin, Poland
    • 61622-KOMED Nova Lublin II
  • Puławy, Poland
    • 61620-KOMED Nova Pulawy
  • Staszów, Poland
    • 61614-KO-MED Centra Kliniczne Staszow
  • Warsaw, Poland
    • 61615-ETG Warszawa
  • Warsaw, Poland
    • 61616-MTZ Clinical Research
  • Warsaw, Poland
    • 61605-RCMed Oddział Warszawa
  • Warsaw, Poland
    • 61621-Futuremed Warszawa Centrum
  • Wroclaw, Poland
    • 61617-Przychodnia FutureMeds Wroclaw
  • Zamość, Poland
    • 61623-KOMED Nova Zamosc
• Romania
  • Bucharest, Romania
    • 64210-Sana Monitoring
  • Calarasi, Romania
    • 64204-Ames Research Center
  • Caracal, Romania
    • 64208-Spitalul Municipal Caracal
  • Reșca, Romania
    • 64209-Clintrial Medical Center
  • Timișoara, Romania
    • 64211-Nova-Clin Medical Research Center
• Serbia
  • Belgrade, Serbia
    • 68803-Clinical Center of Serbia
  • Belgrade, Serbia
    • 68805-Clinical Hospital Center Zemun
  • Belgrade, Serbia
    • 68806-CHC Bezanijska Kosa
  • Kamenitz, Serbia
    • 68802-Institute for Pulmonary Disease of Vojvodina
  • Valjevo, Serbia
    • 68804-General Hospital Valjevo
• South Africa
  • Bloemfontein, South Africa
    • 71007-Josha Research Center
  • Brits, South Africa
    • 71008-Madibeng Centre for Research
  • Cape Town, South Africa
    • 71011-University of Cape Town Lung Institute
  • Cape Town, South Africa
    • 71014-TREAD Research
  • Cape Town, South Africa
    • 71015-Tiervlei Trial Centre
  • Krugersdorp, South Africa
    • 71001-Ubuntu Clinical Research Krugersdorp
  • Middelburg, South Africa
    • 71010-Merclinico Middelburg
  • Newtown, South Africa
    • 71009-Newtown Clinical Research Centre
  • Paarl, South Africa
    • 71005-Be Part Research
  • Pretoria, South Africa
    • 71013-Into Research, Life Groenkloof Hospital
  • Thabazimbi, South Africa
    • 71003-Tsitsikamma Clinical Research Initiative
  • Vereeniging, South Africa
    • 71004-FCRN Clinical Trials Centre
• South Korea
  • Ansan, South Korea
    • 41002-Korea University Ansan Hospital
  • Incheon, South Korea
    • 41001-Inha University Hospital
  • Seoul, South Korea
    • 41004-Hallym University Kangnam Sacred Heart Hospital
  • Seoul, South Korea
    • 41005-Korea University Guro Hospital
  • Suwon, South Korea
    • 41003-Ajou University Hospital
• Spain
  • Barcelona, Spain
    • 72402-EAP Vic - CAP El Remei
  • Cadiz, Spain
    • 72407-Futurmeds Spain Cadiz
  • Madrid, Spain
    • 72405-Futuremeds Spain Madrid
  • Palma de Mallorca, Spain
    • 72404-Hospital Universitario Son Espases
  • Santiago de Compostela, Spain
    • 72403-Complexo Hospitalario Universitario De Santiago
  • Seville, Spain
    • 72406-Futuremeds Spain Sevilla
  • Vigo, Spain
    • 72401-Hospital Povisa
• Taiwan
  • New Taipei City, Taiwan
    • 15803-Taipei Medical University - Shuang Ho Hospital
  • Taichung, Taiwan
    • 15801-China Medical University Hospital
  • Tainan, Taiwan
    • 15802-National Cheng Kung University Hospital
  • Taipei, Taiwan
    • 15804-Taipei Medical University - Wanfang Hospital
  • Taipei, Taiwan
    • 15805-Taipei Medical University
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye)
    • 79209-Hacettepe University Faculty of Medicine
  • Antalya, Turkey (Türkiye)
    • 79207-Akdeniz University Faculty of Medicine
  • Diyarbakır, Turkey (Türkiye)
    • 79212-Dicle Universitesi Tip Fakultesi
  • Istanbul, Turkey (Türkiye)
    • 79205-Goztepe Suleyman Yalcin City Hospital
  • Izmir, Turkey (Türkiye)
    • 791210-Dokuz Eylul University Faculty of Medicine
  • Izmir, Turkey (Türkiye)
    • 79208-Izmir Dr. Suat Seren Pulmonary Hospital
  • Izmir, Turkey (Türkiye)
    • 79213-Ege University Hospital
  • Kocaeli, Turkey (Türkiye), 41380
    • 79204 - Kocaeli University Faculty of Medicine
  • Trabzon, Turkey (Türkiye)
    • 79211-Karadeniz Technical University Faculty of Medicine
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35216
      • 84046-Accel Research Sites - Birmingham
    • Cullman, Alabama, United States, 35055
      • 84075-Cullman Clinical Trials
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • 84112-DM Clinical Research - Phoenix
    • Scottsdale, Arizona, United States, 85260
      • 84114-Scottsdale Clinical Trials
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • 84070-Baptist Health Center for Clinical Research
    • Little Rock, Arkansas, United States, 72204
      • 84045-Lynn Institute of the Ozarks
  • California
    • Dublin, California, United States, 94568
      • 84101-West Coast Research LLC
    • Encino, California, United States, 91316
      • 84124-Leading Edge Research
    • Inglewood, California, United States, 90303
      • 84104-Zillan Clinical Research
    • La Mesa, California, United States, 91942
      • 84105-Eximia Research - CA
    • Long Beach, California, United States, 90805
      • 84107-Long Beach Research Institute
    • Long Beach, California, United States, 90806
      • 84109-Long Beach Clinical Trials
    • Modesto, California, United States, 95350
      • 84115-Central Valley Research
    • Redding, California, United States, 96001
      • 84120-Paradigm Research
    • San Diego, California, United States, 92120
      • 84119-Apex Clinical Research
  • Colorado
    • Aurora, Colorado, United States, 80012
      • 84125-Lynn Institute of Denver
    • Longmont, Colorado, United States, 80501
      • 84110-Tekton Research
    • Wheat Ridge, Colorado, United States, 80033
      • 84123-Paradigm Research
  • Connecticut
    • Milford, Connecticut, United States, 06460
      • 84085-Clinical Research Consulting, LLC
    • Waterbury, Connecticut, United States, 06708
      • 84017-Chase Medical Research, LLC
  • Florida
    • Boynton Beach, Florida, United States, 33435
      • 84029-Imagine Research of Palm Beach County
    • Clearwater, Florida, United States, 33756
      • 84067-Innovative Research of West Florida, Inc.
    • Crystal River, Florida, United States, 34429
      • 84006-Nature Coast Clinical Research - Crystal River
    • Doral, Florida, United States, 33122
      • 84012-Evolution Clinical Trials
    • Doral, Florida, United States, 33126
      • 84016-USA and International Research Inc.
    • Edgewater, Florida, United States, 32132
      • 84061-Velocity Clinical Research - New Smyrna Beach
    • Fleming Island, Florida, United States, 32003
      • 84065-Fleming Island Center for Clinical Research
    • Gainesville, Florida, United States, 32607
      • 84027-SIMEDHealth, LLC
    • Jacksonville, Florida, United States, 32258
      • 84019-Green Leaf Clinical Trials
    • Jupiter, Florida, United States, 33458
      • 84026-Health Awareness, Inc.
    • Lake Worth, Florida, United States, 33460
      • 84071-3SYNC Research
    • Largo, Florida, United States, 33777
      • 84083-Accel Research Sites Network - St. Petersburg-Largo
    • Miami Lakes, Florida, United States, 33016
      • 84082-Global Health Research Center, Inc.
    • Pembroke Pines, Florida, United States, 33024
      • 84081-Suncoast Research Associates, LLC
    • Saint Augustine, Florida, United States, 32086
      • 84024-St. Johns Center for Clinical Research
    • Sunrise, Florida, United States, 33351
      • 84051-Precision Clinical Research
    • Tampa, Florida, United States, 33615
      • 84008-Global Health Research Center, Inc. - Tampa
  • Georgia
    • Atlanta, Georgia, United States, 30328-6124
      • 84086-Agile Clinical Research Trials, LLC
    • Atlanta, Georgia, United States, 30315
      • 84037-Eximia Research - GA
    • Columbus, Georgia, United States, 31904
      • 84054-Centricity Research Columbus
    • Sandy Springs, Georgia, United States, 30103
      • 84013-M3 Wake Research/Mount Vernon Clinical Research, LLC
    • Savannah, Georgia, United States, 31406
      • 84069-Velocity Clinical Research - Savannah
    • Woodstock, Georgia, United States, 30189
      • 84039-North Georgia Clinical Research
  • Idaho
    • Meridian, Idaho, United States, 83642
      • 84118-Velocity Clinical Research - Boise
  • Illinois
    • Chicago, Illinois, United States, 60640
      • 84060-Great Lakes Clinical Trials LLC, dba Flourish Research
    • Melrose Park, Illinois, United States, 60160
      • 84022-DM Clinical Research - River Forest
  • Indiana
    • Valparaiso, Indiana, United States, 46383
      • 84025-Velocity Clinical Research - Valparaiso
  • Iowa
    • Sioux City, Iowa, United States, 51106
      • 84042-Velocity Clinical Research - Sioux City
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • 84055-Velocity Clinical Research - Baton Rouge
    • Covington, Louisiana, United States, 70433
      • 84088-Velocity Clinical Research - Covington
    • Lafayette, Louisiana, United States, 70508
      • 84052-Velocity Clinical Research - Lafayette
    • Metairie, Louisiana, United States, 70006
      • 84064-Benchmark Research
  • Massachusetts
    • Brookline, Massachusetts, United States, 02446
      • 84005-DM Clinical Research - Brookline
    • Methuen, Massachusetts, United States, 01844
      • 84002-ActivMed Practices and Research, LLC
  • Michigan
    • Clarkston, Michigan, United States, 48346
      • 84044-Clarkston Medical Group
    • Farmington Hills, Michigan, United States, 48334
      • 84018-Quest Research Institute
    • Farmington Hills, Michigan, United States, 48336
      • 84032-Bioscope Clinical Research, LLC
    • Southfield, Michigan, United States, 48075
      • 84001-Revival Research Institute, LLC
    • Southfield, Michigan, United States, 48076
      • 84074-DM Clinical Research - Southfield
  • Mississippi
    • Gulfport, Mississippi, United States, 39503
      • 84023-Velocity Clinical Research - Gulfport
  • Missouri
    • Kansas City, Missouri, United States, 64131
      • 84038-Kansas City Research Institute
    • St Louis, Missouri, United States, 63141
      • 84057-Sundance Clinical Research
  • Montana
    • Missoula, Montana, United States, 59804
      • 84108-Boeson Research MSO
  • Nebraska
    • Grand Island, Nebraska, United States, 68803
      • 84030-Velocity Clinical Research - Grand Island
    • Norfolk, Nebraska, United States, 68701
      • 84040-Velocity Clinical Research - Norfolk
    • Omaha, Nebraska, United States, 68134
      • 84007-Velocity Clinical Research - Omaha
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • 84117-M3 Wake Research/CRCN
    • Las Vegas, Nevada, United States, 89119
      • 84103-Alliance for Multispecialty Research, LLC
    • Las Vegas, Nevada, United States, 89128
      • 84111-Vector Clinical Trials
    • North Las Vegas, Nevada, United States, 89030
      • 84106-Las Vegas Clinical Trials
  • New Jersey
    • Jersey City, New Jersey, United States, 07306
      • 84003-DM Clinical Research - New Jersey
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • 84122-Albuquerque Clinical Trials
  • New York
    • Binghamton, New York, United States, 13905
      • 84048-Velocity Clinical Research - Binghamton
    • East Syracuse, New York, United States, 13057
      • 84077-Velocity Clinical Research - Syracuse
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • 84014-Asheville Clinical Research
    • Durham, North Carolina, United States, 27701
      • 84089-Velocity Clinical Research - Durham
    • Monroe, North Carolina, United States, 28112
      • 84035-Monroe Biomedical Research
    • Raleigh, North Carolina, United States, 27607
      • 84102-Eximia Research - NC
    • Raleigh, North Carolina, United States, 27612
      • 84020-M3 Wake Research/Raleigh Clinical Research, LLC
    • Wilmington, North Carolina, United States, 28403
      • 84004-TMA Headlands LLC, dba Trial Management Associates
    • Winston-Salem, North Carolina, United States, 27103
      • 84079-Progressive Medicine of the Triad, LLC
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • 84021-Velocity Clinical Research - Cleveland
    • Cincinnati, Ohio, United States, 45212
      • 84034-CTI Clinical Research Center
    • Cincinnati, Ohio, United States, 45219
      • 84063-Velocity Clinical Research - Cincinnati (Mt. Auburn)
  • Oklahoma
    • Yukon, Oklahoma, United States, 73099
      • 84078-Tekton Research
  • Oregon
    • Medford, Oregon, United States, 97504
      • 84121-Velocity Clinical Research - Medford
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15241
      • 84050-3SYNC Research
  • Rhode Island
    • East Greenwich, Rhode Island, United States, 02818
      • 84009-Velocity Clinical Research - Providence
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • 84010-M3 Wake Research/Charleston Clinical Trials, LLC
    • Gaffney, South Carolina, United States, 29340
      • 84043-Velocity Clinical Research - Gaffney
    • North Charleston, South Carolina, United States, 29405
      • 84056-Coastal Carolina Research Center, LLC
    • Spartanburg, South Carolina, United States, 29303
      • 84047-Velocity Clinical Research - Spartanburg
    • Union, South Carolina, United States, 29379
      • 84053-Velocity Clinical Research - Union
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • 84068-WR-ClinSearch, LLC
    • Knoxville, Tennessee, United States, 37909
      • 84090-Alliance for Multispecialty Research, LLC
    • Nashville, Tennessee, United States, 37203
      • 84084-Clinical Research Associates, Inc.
  • Texas
    • Dallas, Texas, United States, 75224
      • 84072-WR-Global Medical Research, LLC
    • Fort Worth, Texas, United States, 76135
      • 84028-Benchmark Research
    • Houston, Texas, United States, 77008
      • 84015-Trio Clinical Trials LLC
    • Kingwood, Texas, United States, 77339
      • 84062-Activian Clinical Research
    • Plano, Texas, United States, 75024
      • 84080-ACRC Trials
    • Plano, Texas, United States, 75093
      • 84031-North Texas Family Medicine
    • Plano, Texas, United States, 75093
      • 84066-Research Your Health
    • San Antonio, Texas, United States, 78229
      • 84011-Clinical Trials of Texas, LLC, dba Flourish Research
    • San Antonio, Texas, United States, 78257
      • 84076-DM Clinical Research - San Antonio
    • Sugar Land, Texas, United States, 77478
      • 84059-DM Clinical Research - Sugar Land
    • Tomball, Texas, United States, 77375
      • 84087-DM Clinical Research - Tomball
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • 84049-Charlottesville Medical Research
    • Richmond, Virginia, United States, 23226
      • 84058-Clinical Research Partners
    • Suffolk, Virginia, United States, 23435
      • 84036-Velocity Clinical Research - Suffolk
  • Washington
    • Seattle, Washington, United States, 98122
      • 84113-DM Clinical Research - Seattle
• Zimbabwe
  • Harare, Zimbabwe
    • 71601-Charles River Medical Group, Mutala Trust and Infectious Disease Research Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.

1. Adults of ≥65 years of age on the day of vaccination.
2. Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
3. Individuals who have the ability to comply with study procedures including follow-up.

Exclusion Criteria:

In order to participate in this study, all subjects must not meet any of the exclusion criteria described below:

1. Bedridden subjects (i.e. confined to bed by sickness or old age).
2. Subjects that are incapacitated and because of that in need of a Legally Authorized Representative.
3. Receipt of any influenza vaccine within 6 months prior to enrollment or any plan to receive influenza vaccine while participating in the study.
4. Hypersensitivity, including allergy, to any component of vaccines whose use is foreseen in this study, or severe allergic reaction (e.g. anaphylaxis) to previous influenza vaccination.
5. Known history of Guillain-Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis.
6. Clinical conditions representing a contra-indication to intramuscular administration of vaccines or blood draw.

7. Abnormal function of the immune system resulting from:

   1. Clinical conditions;
   2. Systemic administration of corticosteroids (PO/IV/IM) at a dose ≥20 mg/day of prednisone (or equivalent) for more than 14 consecutive days within 90 days prior to informed consent; Topical, inhaled and intranasal corticosteroids are permitted. Intermittent use (one dose in 30 days) of intra-articular corticosteroids are also permitted;
   3. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
8. Receipt of immunoglobulins or any blood products within 180 days prior to informed consent.
9. Receipt of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the study vaccination, or planned use during the entire study period.
10. Acute (severe) febrile illness.
11. Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
12. Study personnel or immediate family members (brother, sister, child, parent) or the spouse of study personnel.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MF59-adjuvanted influenza vaccine; MF59-adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains or MF59-adjuvanted TIV containing 2 influenza type A strains and 1 influenza type B strain	Biological: 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.; Other Names: Fluad Tetra/Quadrivalent or Fluad
Other: Non-adjuvanted influenza vaccine; Non-adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains or Non-adjuvanted TIV containing 2 influenza type A strains and 1 influenza type B strain	Biological: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy Endpoint: First-occurrence of RT-PCR-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), using the protocol-defined ILI definition	ILI = influenza-like illness; RT-PCR = reverse transcription-polymerase chain reaction	From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for Northern Hemisphere [NH] influenza season and end of November for Southern Hemisphere [SH] influenza season)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy Endpoint: First-occurrence of culture-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), using the protocol-defined ILI definition		From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for NH influenza season and end of November for SH influenza season)
Efficacy Endpoint: First-occurrence of RT-PCR-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), using the modified CDC ILI definition	CDC = Centers for Disease Control and Prevention	From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for NH influenza season and end of November for SH influenza season)
Efficacy Endpoint: First-occurrence of RT-PCR-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), using the WHO ILI definition	WHO = World Health Organization	From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for NH influenza season and end of November for SH influenza season)
Immunogenicity Endpoint: Pre- and post-vaccination hemagglutination inhibition (HI) geometric mean titers (GMTs) for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains		Day 1 and Day 22
Immunogenicity Endpoint: Geometric mean fold increase (GMFI, Day 22/Day1) for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains		Day 1 and Day 22
Immunogenicity Endpoint: Percentage of subjects achieving seroconversion for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains	Seroconversion is defined as the percentage of subjects with either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and a ≥4-fold increase in post-vaccination titer.	Day 1 and Day 22
Immunogenicity Endpoint: Percentage of subjects with HI titer ≥1:40 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains		Day 1 and Day 22
Safety Endpoint: All adverse events (AEs) reported within 30 minutes after vaccination		Day 1
Safety Endpoint: Serious adverse events (SAEs) reported during the entire study period		Day 1 to Day 181 or the end of the influenza season, whichever is longer
Safety Endpoint: Adverse events of special interest (AESIs) reported during the entire study period		Day 1 to Day 181 or the end of the influenza season, whichever is longer
Safety Endpoint: AEs leading to premature withdrawal from the study during the entire study period		Day 1 to Day 181 or the end of the influenza season, whichever is longer
Efficacy Endpoint: First-occurrence of RT-PCR-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), using the protocol-defined ILI definition		From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for NH influenza season and end of November for SH influenza season)
Efficacy Endpoint: First-occurrence of culture-confirmed influenza, due to influenza Type A and/or B virus antigenically matched to the vaccine strains selected for the seasonal vaccine, using the protocol-defined ILI definition		From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for NH influenza season and end of November for SH influenza season)
Efficacy Endpoint: First-occurrence of culture-confirmed influenza, due to influenza Type A and/or B virus antigenically unmatched to the vaccine strains selected for the seasonal vaccine, using the protocol-defined ILI definition		From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for NH influenza season and end of November for SH influenza season)

Collaborators and Investigators

• Sponsor: Seqirus
• Investigators: Study Director: Clinical Program Director, Seqirus

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 28, 2023
• First Submitted That Met QC Criteria: October 11, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Influenza; Vaccine; MF59 adjuvant; A/H1N1; aQIV; A/H3N2; B/Yamagata; B/Victoria; aTIV
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Influenza, Human; Biological Products; Complex Mixtures; Vaccines; Viral Vaccines; Influenza Vaccines
• Other Study ID Numbers: V118_24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Seqirus will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact Seqirus at seqirus.clinicaltrials@seqirus.com.
• IPD Sharing Time Frame: Requests for IPD will generally be considered once review by major regulatory authorities (ie FDA, EMA) is complete and the primary publication is available.

IPD Sharing Access Criteria

Proposed research should seek to answer a previously unanswered important medical or scientific question.

Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.

If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No