AzTrials
AzTrials

Influenza, HumanPhase 3NCT06087640

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 study testing aQIV or aTIV and QIV or TIV in people with Influenza, Human, run by Seqirus at 255 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Influenza, Human
What is being tested?
aQIV or aTIV and QIV or TIV
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38,769 participants
Where
255 sitesin 21 countries
Study dates
23 Oct 2023to 15 Jun 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.
  • Adults of ≥65 years of age on the day of vaccination.
  • 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.
  • Individuals who have the ability to comply with study procedures including follow-up.

Who cannot join

  • In order to participate in this study, all subjects must not meet any of the exclusion criteria described below:
  • Bedridden subjects (i.e. confined to bed by sickness or old age).
  • Subjects that are incapacitated and because of that in need of a Legally Authorized Representative.
  • Receipt of any influenza vaccine within 6 months prior to enrollment or any plan to receive influenza vaccine while participating in the study.
  • 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.
  • Known history of Guillain-Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis.
Show all 16Show fewer
  • Clinical conditions representing a contra-indication to intramuscular administration of vaccines or blood draw.
  • Abnormal function of the immune system resulting from:
  • Clinical conditions;
  • 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;
  • Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
  • Receipt of immunoglobulins or any blood products within 180 days prior to informed consent.
  • 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.
  • Acute (severe) febrile illness.
  • 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.
  • Study personnel or immediate family members (brother, sister, child, parent) or the spouse of study personnel.

Trial locations and contacts

255 sites in 21 countries.

255 sites in 21 countries

United States111 sites

  • 84122-Albuquerque Clinical Trials

    Albuquerque, New Mexico, 87102

  • 84014-Asheville Clinical Research

    Asheville, North Carolina, 28803

  • 84037-Eximia Research - GA

    Atlanta, Georgia, 30315

  • 84086-Agile Clinical Research Trials, LLC

    Atlanta, Georgia, 30328-6124

  • 84125-Lynn Institute of Denver

    Aurora, Colorado, 80012

  • 84055-Velocity Clinical Research - Baton Rouge

    Baton Rouge, Louisiana, 70809

  • 84021-Velocity Clinical Research - Cleveland

    Beachwood, Ohio, 44122

  • 84048-Velocity Clinical Research - Binghamton

    Binghamton, New York, 13905

  • 84046-Accel Research Sites - Birmingham

    Birmingham, Alabama, 35216

  • 84029-Imagine Research of Palm Beach County

    Boynton Beach, Florida, 33435

  • 84005-DM Clinical Research - Brookline

    Brookline, Massachusetts, 02446

  • 84010-M3 Wake Research/Charleston Clinical Trials, LLC

    Charleston, South Carolina, 29414

  • 84049-Charlottesville Medical Research

    Charlottesville, Virginia, 22911

  • 84068-WR-ClinSearch, LLC

    Chattanooga, Tennessee, 37421

  • 84060-Great Lakes Clinical Trials LLC, dba Flourish Research

    Chicago, Illinois, 60640

  • 84034-CTI Clinical Research Center

    Cincinnati, Ohio, 45212

  • 84063-Velocity Clinical Research - Cincinnati (Mt. Auburn)

    Cincinnati, Ohio, 45219

  • 84044-Clarkston Medical Group

    Clarkston, Michigan, 48346

  • 84067-Innovative Research of West Florida, Inc.

    Clearwater, Florida, 33756

  • 84054-Centricity Research Columbus

    Columbus, Georgia, 31904

  • 84088-Velocity Clinical Research - Covington

    Covington, Louisiana, 70433

  • 84006-Nature Coast Clinical Research - Crystal River

    Crystal River, Florida, 34429

  • 84075-Cullman Clinical Trials

    Cullman, Alabama, 35055

  • 84072-WR-Global Medical Research, LLC

    Dallas, Texas, 75224

  • 84016-USA and International Research Inc.

    Doral, Florida, 33126

  • 84101-West Coast Research LLC

    Dublin, California, 94568

  • 84089-Velocity Clinical Research - Durham

    Durham, North Carolina, 27701

  • 84009-Velocity Clinical Research - Providence

    East Greenwich, Rhode Island, 02818

  • 84077-Velocity Clinical Research - Syracuse

    East Syracuse, New York, 13057

  • 84061-Velocity Clinical Research - New Smyrna Beach

    Edgewater, Florida, 32132

  • 84124-Leading Edge Research

    Encino, California, 91316

  • 84018-Quest Research Institute

    Farmington Hills, Michigan, 48334

  • 84032-Bioscope Clinical Research, LLC

    Farmington Hills, Michigan, 48336

  • 84065-Fleming Island Center for Clinical Research

    Fleming Island, Florida, 32003

  • 84028-Benchmark Research

    Fort Worth, Texas, 76135

  • 84043-Velocity Clinical Research - Gaffney

    Gaffney, South Carolina, 29340

  • 84027-SIMEDHealth, LLC

    Gainesville, Florida, 32607

  • 84030-Velocity Clinical Research - Grand Island

    Grand Island, Nebraska, 68803

  • 84023-Velocity Clinical Research - Gulfport

    Gulfport, Mississippi, 39503

  • 84015-Trio Clinical Trials LLC

    Houston, Texas, 77008

  • 84104-Zillan Clinical Research

    Inglewood, California, 90303

  • 84019-Green Leaf Clinical Trials

    Jacksonville, Florida, 32258

  • 84003-DM Clinical Research - New Jersey

    Jersey City, New Jersey, 07306

  • 84026-Health Awareness, Inc.

    Jupiter, Florida, 33458

  • 84038-Kansas City Research Institute

    Kansas City, Missouri, 64131

  • 84062-Activian Clinical Research

    Kingwood, Texas, 77339

  • 84090-Alliance for Multispecialty Research, LLC

    Knoxville, Tennessee, 37909

  • 84105-Eximia Research - CA

    La Mesa, California, 91942

  • 84052-Velocity Clinical Research - Lafayette

    Lafayette, Louisiana, 70508

  • 84071-3SYNC Research

    Lake Worth, Florida, 33460

  • 84083-Accel Research Sites Network - St. Petersburg-Largo

    Largo, Florida, 33777

  • 84117-M3 Wake Research/CRCN

    Las Vegas, Nevada, 89106

  • 84103-Alliance for Multispecialty Research, LLC

    Las Vegas, Nevada, 89119

  • 84111-Vector Clinical Trials

    Las Vegas, Nevada, 89128

  • 84045-Lynn Institute of the Ozarks

    Little Rock, Arkansas, 72204

  • 84070-Baptist Health Center for Clinical Research

    Little Rock, Arkansas, 72205

  • 84107-Long Beach Research Institute

    Long Beach, California, 90805

  • 84109-Long Beach Clinical Trials

    Long Beach, California, 90806

  • 84110-Tekton Research

    Longmont, Colorado, 80501

  • 84121-Velocity Clinical Research - Medford

    Medford, Oregon, 97504

  • 84022-DM Clinical Research - River Forest

    Melrose Park, Illinois, 60160

  • 84118-Velocity Clinical Research - Boise

    Meridian, Idaho, 83642

  • 84064-Benchmark Research

    Metairie, Louisiana, 70006

  • 84002-ActivMed Practices and Research, LLC

    Methuen, Massachusetts, 01844

  • 84012-Evolution Clinical Trials

    Miami, Florida, 33122

  • 84082-Global Health Research Center, Inc.

    Miami Lakes, Florida, 33016

  • 84085-Clinical Research Consulting, LLC

    Milford, Connecticut, 06460

  • 84108-Boeson Research MSO

    Missoula, Montana, 59804

  • 84115-Central Valley Research

    Modesto, California, 95350

  • 84035-Monroe Biomedical Research

    Monroe, North Carolina, 28112

  • 84084-Clinical Research Associates, Inc.

    Nashville, Tennessee, 37203

  • 84040-Velocity Clinical Research - Norfolk

    Norfolk, Nebraska, 68701

  • 84056-Coastal Carolina Research Center, LLC

    North Charleston, South Carolina, 29405

  • 84106-Las Vegas Clinical Trials

    North Las Vegas, Nevada, 89030

  • 84007-Velocity Clinical Research - Omaha

    Omaha, Nebraska, 68134

  • 84081-Suncoast Research Associates, LLC

    Pembroke Pines, Florida, 33024

  • 84112-DM Clinical Research - Phoenix

    Phoenix, Arizona, 85012

  • 84050-3SYNC Research

    Pittsburgh, Pennsylvania, 15241

  • 84080-ACRC Trials

    Plano, Texas, 75024

  • 84031-North Texas Family Medicine

    Plano, Texas, 75093

  • 84066-Research Your Health

    Plano, Texas, 75093

  • 84102-Eximia Research - NC

    Raleigh, North Carolina, 27607

  • 84020-M3 Wake Research/Raleigh Clinical Research, LLC

    Raleigh, North Carolina, 27612

  • 84120-Paradigm Research

    Redding, California, 96001

  • 84058-Clinical Research Partners

    Richmond, Virginia, 23226

  • 84024-St. Johns Center for Clinical Research

    Saint Augustine, Florida, 32086

  • 84011-Clinical Trials of Texas, LLC, dba Flourish Research

    San Antonio, Texas, 78229

  • 84076-DM Clinical Research - San Antonio

    San Antonio, Texas, 78257

  • 84119-Apex Clinical Research

    San Diego, California, 92120

  • 84013-M3 Wake Research/Mount Vernon Clinical Research, LLC

    Sandy Springs, Georgia, 30103

  • 84069-Velocity Clinical Research - Savannah

    Savannah, Georgia, 31406

  • 84114-Scottsdale Clinical Trials

    Scottsdale, Arizona, 85260

  • 84113-DM Clinical Research - Seattle

    Seattle, Washington, 98122

  • 84042-Velocity Clinical Research - Sioux City

    Sioux City, Iowa, 51106

  • 84001-Revival Research Institute, LLC

    Southfield, Michigan, 48075

  • 84074-DM Clinical Research - Southfield

    Southfield, Michigan, 48076

  • 84047-Velocity Clinical Research - Spartanburg

    Spartanburg, South Carolina, 29303

  • 84057-Sundance Clinical Research

    St Louis, Missouri, 63141

  • 84036-Velocity Clinical Research - Suffolk

    Suffolk, Virginia, 23435

  • 84059-DM Clinical Research - Sugar Land

    Sugar Land, Texas, 77478

  • 84051-Precision Clinical Research

    Sunrise, Florida, 33351

  • 84008-Global Health Research Center, Inc. - Tampa

    Tampa, Florida, 33615

  • 84087-DM Clinical Research - Tomball

    Tomball, Texas, 77375

  • 84053-Velocity Clinical Research - Union

    Union, South Carolina, 29379

  • 84025-Velocity Clinical Research - Valparaiso

    Valparaiso, Indiana, 46383

  • 84017-Chase Medical Research, LLC

    Waterbury, Connecticut, 06708

  • 84123-Paradigm Research

    Wheat Ridge, Colorado, 80033

  • 84004-TMA Headlands LLC, dba Trial Management Associates

    Wilmington, North Carolina, 28403

  • 84079-Progressive Medicine of the Triad, LLC

    Winston-Salem, North Carolina, 27103

  • 84039-North Georgia Clinical Research

    Woodstock, Georgia, 30189

  • 84078-Tekton Research

    Yukon, Oklahoma, 73099

Other trials in United States

Bulgaria21 sites

  • 10005-MHAT Dr. Tota Venkova

    Gabrovo

  • 10018-Medical Center - Zdrave-1

    Kozloduy

  • 10029-Medical Centre Leo Clinic EOOD

    Lovech

  • 10007-Medical Center Hera EOOD

    Montana

  • 10014-Multi-Profile Hospital For Active Treatment Dr. Stamen Iliev AD

    Montana

  • 10032-Outpatient Clinic For Individual Practice For Primary Medical Care Dr. Valya Videnova-Avramova EOOD

    Pazardzhik

  • 10019-MC Med Consult Pleven

    Pleven

  • 10022-Ambulatory Outpatient Medical Practice for First Patient Care Zaprin Pepelov

    Plovdiv

  • 10024-Diagnostic Consultative Center PulMed EOOD

    Plovdiv

  • 10026-Multiprofile Hospital for Active Treatment Sv. Panteleymon - Plovdiv

    Plovdiv

  • 10031-Medical Centre Pratia Clinic EOOD

    Plovdiv

  • 10004-Medical Center Prolet EOOD

    Rousse

  • 10012-Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov-Ruse EOOD

    Rousse

  • 10016-Diagnostic Consultative Center - 1 - Sevlievo EOOD

    Sevlievo

  • 10023-DCC-1 Sliven

    Sliven

  • 10006-DCC 22 - Sofia

    Sofia

  • 10015-Medical Center Hera - Pulmonology Office

    Sofia

  • 10021-Medical Center Intermedica OOD

    Sofia

  • 10028-Medical Center Excelsior OOD

    Sofia

  • 10030-Diagnostic-Consultative Centre Ascendent EOOD

    Sofia

  • 10027-AIPPMP Dr. Zhaneta Demireva

    Stamboliyski

Other trials in Bulgaria

Australia14 sites

  • 03603-University of the Sunshine Coast - Birtinya

    Birtinya

  • 03609-Paratus Clinical Western Sydney

    Blacktown

  • 03605-Emeritus Research - Sydney

    Botany

  • 03614-Northern Beaches Clinical Research

    Brookvale

  • 03602-Emeritus Research - Melbourne

    Camberwell

  • 03615-Momentum Clinical Research Darlinghurst

    Darlinghurst

  • 03608-Paratus Clinical Brisbane

    Herston

  • 03610-Paratus Clinical Central Coast

    Kanwal

  • 03604-Doherty Clinical Trials Limited

    Melbourne

  • 03611-Nucleus Network

    Melbourne

  • 03601-University of the Sunshine Coast - Morayfield

    Morayfield

  • 03607-University of the Sunshine Coast - South Bank

    South Brisbane

  • 03613-Momentum Clinical Research Taringa

    Taringa

  • 03612-Wollongong Clinical Research

    Wollongong

Other trials in Australia

Philippines14 sites

  • 60812-Health Index Multispecialty and Lying-In Clinic

    Bacoor

  • 60813-Norzel Medical and Diagnostic Clinic

    Cebu

  • 60808-CARE Clinical Trial Group

    Dasmariñas

  • 60801-Davao Doctors Hospital

    Davao City

  • 60802-West Visayas State University Medical Center

    Iloilo City

  • 60815-St. Paul's Hospital of Iloilo, Inc.

    Iloilo City

  • 60816-St. Paul's Hospital of Iloilo, Inc.

    Iloilo City

  • 60803-UP-Philippine General Hospital

    Manila

  • 60811-Philippine General Hospital

    Manila

  • 60814-Manila Doctors Hospital

    Manila

  • 60804-Marilao St. Michael Family Hospital

    Marilao

  • 60805-San Juan de Dios Hospital

    Pasay

  • 60806-Quirino Memorial Medical Center

    Quezon City

  • 60817-Silang Specialist Medical Center

    Silang

Other trials in Philippines

South Africa13 sites

  • 71007-Josha Research

    Bloemfontein

  • 71008-Madibeng Centre for Research

    Brits

  • 71011-University of Cape Town Lung Institute

    Cape Town

  • 71014-TREAD Research

    Cape Town

  • 71015-Tiervlei Trial Centre

    Cape Town

  • 71001-Ubuntu Clinical Research Krugersdorp

    Krugersdorp

  • 71006-DJW Research

    Krugersdorp

  • 71010-Merclinco Middelburg

    Middelburg

  • 71009-Newtown Clinical Research Centre

    Newtown

  • 71005-Be Part Research

    Paarl

  • 71003-Tsitsikamma Clinical Research Initiative

    Plettenberg Bay

  • 71013-Into Research, Life Groenkloof Hospital

    Pretoria

  • 71004-FCRN Clinical Trials Centre

    Vereeniging

Other trials in South Africa

Poland11 sites

  • 61619-Krakowskie Centrum Medyczne Sp. z o.o

    Krakow

  • 61618-FutureMeds Łódź

    Lodz

  • 61622-KO-MED Centra Kliniczne Lublin II

    Lublin

  • 61620-Velocity Nova Sp. z o.o.

    Puławy

  • 61605-RCMed Oddzial Sochaczew

    Sochaczew

  • 61614-KO-MED Centra Kliniczne Staszow

    Staszów

  • 61615-ETG Warszawa

    Warsaw

  • 61616-FutureMeds Targowek

    Warsaw

  • 61621-FutureMeds Warszawa Centrum

    Warsaw

  • 61617-FutureMeds Wroclaw

    Wroclaw

  • 61623-KO-MED Nova Zamość

    Zamość

Other trials in Poland

Turkey (Türkiye)9 sites

  • 79209-Hacettepe University Faculty of Medicine

    Ankara

  • 79207-Akdeniz University Faculty of Medicine

    Antalya

  • 79212-Dicle Universitesi Tip Fakultesi

    Diyarbakır

  • 79205-Goztepe Suleyman Yalcin City Hospital

    Istanbul

  • 791210-Dokuz Eylul University Faculty of Medicine

    Izmir

  • 79208-Izmir Dr. Suat Seren Pulmonary Hospital

    Izmir

  • 79213-Ege University Hospital

    Izmir

  • 79204 - Kocaeli University Faculty of Medicine

    Kocaeli

  • 79211-Karadeniz Technical University Faculty of Medicine

    Trabzon

Other trials in Turkey (Türkiye)

Czechia8 sites

  • 20307-CCR Brno s.r.o.

    Brno

  • 20306-ADMED, s.r.o.

    České Budějovice

  • 20311-Ordinace Hradebni s.r.o

    České Budějovice

  • 20305-Centrum ockovani a cestovni mediciny

    Hradec Králové

  • 20310-MUDr. Jakub Strincl, s.r.o.

    Liberec

  • 20309-CCR Ostrava, s.r.o.

    Ostrava

  • 20312-MEDISON s.r.o.

    Přeštice

  • 20308-Zdravi - fit, s.r.o.

    Protivín

Other trials in Czechia

Spain7 sites

  • 72402-EAP Vic - CAP El Remei

    Barcelona

  • 72407-FutureMeds Spain Cadiz

    Cadiz

  • 72405-FutureMeds Spain Madrid

    Madrid

  • 72404-Hospital Universitario Son Espases

    Palma de Mallorca

  • 72403-Complexo Hospitalario Universitario De Santiago

    Santiago de Compostela

  • 72406-FutureMeds Spain Sevilla

    Seville

  • 72401-Hospital Ribera Povisa

    Vigo

Other trials in Spain

New Zealand5 sites

  • 55404-Optimal Clinical Trials - Central

    Grafton

  • 55405-Pacific Clinical Research Network - West Auckland

    New Lynn

  • 55403-Optimal Clinical Trials - North

    Rosedale

  • 55401-Pacific Clinical Research Network - Auckland

    Takapuna

  • 55402-P3 Research Wellington

    Wellington

Other trials in New Zealand

Romania5 sites

  • 64210-Sana Monitoring

    Bucharest

  • 64204-Ames Research Center

    Calarasi

  • 64208-Spitalul Municipal Caracal

    Caracal

  • 64209-Clintrial Medical Center

    Reșca

  • 64211-Nova-Clin Medical Research Center

    Timișoara

Other trials in Romania

Serbia5 sites

  • 68803-Clinical Center of Serbia

    Belgrade

  • 68805-Clinical Hospital Center Zemun

    Belgrade

  • 68806-CHC Bezanijska Kosa

    Belgrade

  • 68802-Institute for Pulmonary Disease of Vojvodina

    Kamenitz

  • 68804-General Hospital Valjevo

    Valjevo

Other trials in Serbia

South Korea5 sites

  • 41002-Korea University Ansan Hospital

    Ansan

  • 41001-Inha University Hospital

    Incheon

  • 41004-Hallym University Kangnam Sacred Heart Hospital

    Seoul

  • 41005-Korea University Guro Hospital

    Seoul

  • 41003-Ajou University Hospital

    Suwon

Other trials in South Korea

Taiwan5 sites

  • 15803-Taipei Medical University - Shuang Ho Hospital

    New Taipei City

  • 15801-China Medical University Hospital

    Taichung

  • 15802-National Cheng Kung University Hospital

    Tainan

  • 15804-Taipei Medical University - Wanfang Hospital

    Taipei

  • 15805-Taipei Medical University Hospital

    Taipei

Other trials in Taiwan

Belgium4 sites

  • 05605-AZ Sint-Jan Brugge-Oostende - Campus Sint-Jan

    Bruges

  • 05602-Universitair Ziekenhuis Gent

    Ghent

  • 05603-Medif BVBA

    Gozée

  • 05601-Jan Yperman Ziekenhuis

    Ieper

Other trials in Belgium

Finland4 sites

  • 24603-Helsinki South Vaccine Research Clinic

    Helsinki

  • 24602-Oulu Vaccine Research Clinic

    Oulu

  • 24601-Tampere Vaccine Research Clinic

    Tampere

  • 24604-Turku Vaccine Research Clinic

    Turku

Other trials in Finland

Georgia4 sites

  • 26803-LTD "High Technology Hospital Medcenter"

    Batumi

  • 26801-LTD Hospital Service

    Kutaisi

  • 26802-Acad. G. Chapidze Emergency Cardiology Center

    Tbilisi

  • 26804-K. Eristavi National Center of Clinical Surgery

    Tbilisi

Other trials in Georgia

Lithuania4 sites

  • 44004-UAB InMedica

    Kaunas

  • 44008-JSC Saulės Šeimos Medicinos Centras

    Kaunas

  • 44009-Hospital of Lithuanian University of Health Sciences Kauno klinikos

    Kaunas

  • 44010-Inlita JSC Santara CTC

    Vilnius

Other trials in Lithuania

Italy3 sites

  • 38003-AOUC Policlinico di Bari

    Bari

  • 38001-PO A. Manzoni di Lecco, ASST Lecco

    Lecco

  • 38004-Ospedale Fatebenefratelli e Oftalmico, ASST Fatebenefratelli Sacco

    Milan

Other trials in Italy

Netherlands2 sites

  • 52802-Emotional Brain BV

    Almere Stad

  • 52804-Stichting European Clinical Research Alliance on Infectious Diseases

    Utrecht

Other trials in Netherlands

Zimbabwe1 site

  • 71601-Charles River Medical Group, Mutala Trust and Infectious Disease Research Laboratory

    Harare

Other trials in Zimbabwe

About this study

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

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.

Being tested
aQIV or aTIV, QIV or TIV
Keywords
Influenza, Vaccine, MF59 adjuvant, aQIV, aTIV, A/H1N1, A/H3N2, B/Yamagata, B/Victoria
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • aQIV or aTIVBiological

    Also called Fluad Tetra/Quadrivalent or Fluad

    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 TIVBiological

    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.

Study groups in NCT06087640
Study groupRoleWhat they receive
MF59-adjuvanted influenza vaccineExperimentalMF59-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
Receives: Biological: aQIV or aTIV
Non-adjuvanted influenza vaccineOtherNon-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
Receives: Biological: QIV or TIV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 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 outcomes (14)

  1. 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

    Measured: 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)

  2. 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

    Measured: 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)

  3. 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

    Measured: 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)

  4. 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

    Measured: 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)

  5. 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

    Measured: 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)

  6. 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

    Measured: 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)

  7. 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

    Measured: Day 1 and Day 22

  8. Immunogenicity Endpoint: Geometric mean fold increase (GMFI, Day 22/Day1) for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains

    Measured: Day 1 and Day 22

  9. 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.

    Measured: Day 1 and Day 22

  10. Immunogenicity Endpoint: Percentage of subjects with HI titer ≥1:40 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains

    Measured: Day 1 and Day 22

  11. Safety Endpoint: All adverse events (AEs) reported within 30 minutes after vaccination

    Measured: Day 1

  12. Safety Endpoint: Serious adverse events (SAEs) reported during the entire study period

    Measured: Day 1 to Day 181 or the end of the influenza season, whichever is longer

  13. Safety Endpoint: Adverse events of special interest (AESIs) reported during the entire study period

    Measured: Day 1 to Day 181 or the end of the influenza season, whichever is longer

  14. Safety Endpoint: AEs leading to premature withdrawal from the study during the entire study period

    Measured: Day 1 to Day 181 or the end of the influenza season, whichever is longer

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2023
  2. Study start23 Oct 2023
  3. Primary completion26 May 2026
  4. Study completion15 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
38,769 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06087640
Sponsor's protocol ID
V118_24
Status last verified
Jun 2026
First submitted
28 Sep 2023
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing aQIV or aTIV and QIV or TIV in people with Influenza, Human, run by Seqirus at 255 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 255 sites in United States, Bulgaria, Australia, Philippines, South Africa and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06087640.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.

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