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

Last updated: June 23, 2025
Sponsor: Seqirus
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

aQIV

aQIV or aTIV

QIV or TIV

Clinical Study ID

NCT06087640
V118_24
  • Ages > 65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 ofthe study has been explained according to local regulatory requirements, prior tostudy entry.

  3. Individuals who have the ability to comply with study procedures includingfollow-up.

Exclusion

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 AuthorizedRepresentative.

  3. Receipt of any influenza vaccine within 6 months prior to enrollment or any plan toreceive influenza vaccine while participating in the study.

  4. Hypersensitivity, including allergy, to any component of vaccines whose use isforeseen in this study, or severe allergic reaction (e.g. anaphylaxis) to previousinfluenza vaccination.

  5. Known history of Guillain-Barré syndrome or another demyelinating disease such asencephalomyelitis and transverse myelitis.

  6. Clinical conditions representing a contra-indication to intramuscular administrationof vaccines or blood draw.

  7. Abnormal function of the immune system resulting from:

  8. Clinical conditions;

  9. Systemic administration of corticosteroids (PO/IV/IM) at a dose ≥20 mg/day ofprednisone (or equivalent) for more than 14 consecutive days within 90 daysprior to informed consent; Topical, inhaled and intranasal corticosteroids arepermitted. Intermittent use (one dose in 30 days) of intra-articularcorticosteroids are also permitted;

  10. Administration of antineoplastic and immunomodulating agents or radiotherapywithin 90 days prior to informed consent.

  11. Receipt of immunoglobulins or any blood products within 180 days prior to informedconsent.

  12. Receipt of any investigational or non-registered product (drug or vaccine) otherthan the study vaccine within 30 days preceding the study vaccination, or planneduse during the entire study period.

  13. Acute (severe) febrile illness.

  14. Any other clinical condition that, in the opinion of the investigator, mightinterfere with the results of the study or pose additional risk to the subject dueto participation in the study.

  15. Study personnel or immediate family members (brother, sister, child, parent) or thespouse of study personnel.

Study Design

Total Participants: 35800
Treatment Group(s): 4
Primary Treatment: aQIV
Phase: 3
Study Start date:
October 23, 2023
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • 03603-University of the Sunshine Coast

    Birtinya,
    Australia

    Active - Recruiting

  • 03609-Paratus Clinical Western Sydney

    Blacktown,
    Australia

    Active - Recruiting

  • 03605-Emeritus Research - Sydney

    Botany,
    Australia

    Active - Recruiting

  • 03614-Northern Beaches Clinical Research

    Brookvale,
    Australia

    Active - Recruiting

  • 03602-Emeritus Research - Melbourne

    Camberwell,
    Australia

    Active - Recruiting

  • 03615-Momentum Clinical Research Darlinghurst

    Darlinghurst,
    Australia

    Active - Recruiting

  • 03608-Paratus Clinical Brisbane

    Herston,
    Australia

    Active - Recruiting

  • 03610-Paratus Clinical Central Coast

    Kanwal,
    Australia

    Active - Recruiting

  • 03604-Doherty Clinical Trials Limited

    Melbourne,
    Australia

    Active - Recruiting

  • 03611-Nucleus Network

    Melbourne,
    Australia

    Active - Recruiting

  • 03601-University of the Sunshine Coast - Morayfield

    Morayfield,
    Australia

    Active - Recruiting

  • 03607-University of the Sunshine Coast - South Bank

    South Brisbane,
    Australia

    Active - Recruiting

  • 03613-Momentum Clinical Research Taringa

    Taringa,
    Australia

    Active - Recruiting

  • 03612-Wollongong Clinical Reserach

    Wollongong,
    Australia

    Active - Recruiting

  • 05601-AZ Sint-Jan Brugge-Oostende - Campus Sint-Jan

    Brugge,
    Belgium

    Active - Recruiting

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

    Brugge,
    Belgium

    Site Not Available

  • 05602-Universitair Ziekenhuis Gent

    Gent,
    Belgium

    Site Not Available

  • 05602-Universitair Ziekenhuis Gent

    Ghent,
    Belgium

    Site Not Available

  • 05603-Medif BVBA

    Gozée,
    Belgium

    Site Not Available

  • 05603-ResearchLink

    Linkebeek,
    Belgium

    Site Not Available

  • 05601-Jan Yperman Ziekenhuis

    Ypres,
    Belgium

    Site Not Available

  • 10005-MHAT Dr. Tota Venkova

    Gabrovo,
    Bulgaria

    Site Not Available

  • 10018-Medical Center - Zdrave-1

    Kozloduy,
    Bulgaria

    Site Not Available

  • 10029-Medical Centre Leo Clinic EOOD

    Lovech,
    Bulgaria

    Site Not Available

  • 10007-Medical Center Hera EOOD

    Montana,
    Bulgaria

    Site Not Available

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

    Montana,
    Bulgaria

    Site Not Available

  • 10032-MHAT Zdrave

    Pazardzhik,
    Bulgaria

    Site Not Available

  • 10019-MC Med Consult Pleven

    Pleven,
    Bulgaria

    Site Not Available

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

    Plovdiv,
    Bulgaria

    Site Not Available

  • 10024-UMHAT Pulmed

    Plovdiv,
    Bulgaria

    Site Not Available

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

    Plovdiv,
    Bulgaria

    Site Not Available

  • 10031-Medical Centre Pratia Clinic EOOD

    Plovdiv,
    Bulgaria

    Site Not Available

  • 10004-Medical Center Prolet EOOD

    Ruse,
    Bulgaria

    Site Not Available

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

    Ruse,
    Bulgaria

    Site Not Available

  • 10016-Diagnostic Consultative Center - 1 - Sevlievo EOOD

    Sevlievo,
    Bulgaria

    Site Not Available

  • 10016-Medical Center 1 - Sevlievo EOOD

    Sevlievo,
    Bulgaria

    Site Not Available

  • 10023-DCC-1 Sliven

    Sliven,
    Bulgaria

    Site Not Available

  • 10006-DCC 22 - Sofia

    Sofia,
    Bulgaria

    Site Not Available

  • 10015-Medical Center Hera - Pulmonology Office

    Sofia,
    Bulgaria

    Site Not Available

  • 10021-Medical Center Intermedica

    Sofia,
    Bulgaria

    Site Not Available

  • 10028-Medical Center Excelsior OOD

    Sofia,
    Bulgaria

    Site Not Available

  • 10030-Diagnostic-Consultative Centre Ascendent EOOD

    Sofia,
    Bulgaria

    Site Not Available

  • 10027-AIPPMP D-r Zhaneta Demireva

    Stamboliyski,
    Bulgaria

    Site Not Available

  • 20307-CCR Brno s.r.o.

    Brno,
    Czech Republic

    Active - Recruiting

  • 20310-MUDr. Jakub Strincl, s.r.o.

    Liberec,
    Czech Republic

    Active - Recruiting

  • 20309-CCR Ostrava, s.r.o.

    Ostrava,
    Czech Republic

    Active - Recruiting

  • 20305-Centrum ockovani a cestovni mediciny

    České Budějovice,
    Czech Republic

    Active - Recruiting

  • 20306-ADMED, s.r.o.

    České Budějovice,
    Czech Republic

    Active - Recruiting

  • 20307-CCR Brno s.r.o.

    Brno,
    Czechia

    Site Not Available

  • 20310-MUDr. Jakub Strincl, s.r.o.

    Liberec,
    Czechia

    Site Not Available

  • 20309-CCR Ostrava, s.r.o.

    Ostrava,
    Czechia

    Site Not Available

  • 20308-MUDr. Jakub Strincl, s.r.o.

    Protivin,
    Czechia

    Site Not Available

  • 20308-Zdravi - fit, s.r.o.

    Protivín,
    Czechia

    Site Not Available

  • 20312-MEDISON s.r.o.

    Přeštice,
    Czechia

    Site Not Available

  • 20305-Centrum ockovani a cestovni mediciny

    České Budějovice,
    Czechia

    Site Not Available

  • 20305-Prof. MUDr. Jiri Beran, s.r.o.

    České Budějovice,
    Czechia

    Site Not Available

  • 20306-ADMED, s.r.o.

    České Budějovice,
    Czechia

    Site Not Available

  • 20311-Ordinace Hradebni s.r.o

    České Budějovice,
    Czechia

    Site Not Available

  • 24603-Helsinki South Vaccine Research Clinic

    Helsinki,
    Finland

    Site Not Available

  • 24602-Oulu Vaccine Research Clinic

    Oulu,
    Finland

    Site Not Available

  • 24601-Tampere Vaccine Research Clinic

    Tampere,
    Finland

    Site Not Available

  • 24601-Vaccine Research Center Tampere - Research Center Tampere University

    Tampere,
    Finland

    Active - Recruiting

  • 24604-Turku Vaccine Research Clinic

    Turku,
    Finland

    Completed

  • 26803 - JSC Evex Hospitals

    Batumi, 6010
    Georgia

    Site Not Available

  • 26803-JSC Evex Hospitals

    Batumi,
    Georgia

    Site Not Available

  • 26803-UNIMED Adjara LTD - Batumi Referral Hospital

    Batumi,
    Georgia

    Site Not Available

  • 26801 - LTD Hospital Service

    Kutaisi, 4600
    Georgia

    Site Not Available

  • 26801-LTD Hospital Service

    Kutaisi,
    Georgia

    Site Not Available

  • 26802 - LTD Emergency Cardiology Center

    Tbilisi, 0159
    Georgia

    Site Not Available

  • 26802-Acad. G. Chapidze Emergency Cardiology Center

    Tbilisi,
    Georgia

    Site Not Available

  • 26804 - JSC Eristavi National Center

    Tbilisi, 0159
    Georgia

    Site Not Available

  • 26804-K. Eristavi National Center of Clinical Surgery

    Tbilisi,
    Georgia

    Site Not Available

  • 38003-Policlinico Bari

    Bari,
    Italy

    Site Not Available

  • 38003-University Hospital Consorziale Policlinico

    Bari,
    Italy

    Site Not Available

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

    Lecco,
    Italy

    Site Not Available

  • 38004-Ospedale Fatebenefratelli e Oftalmico, ASST Fatebenefratelli Sacco

    Milano,
    Italy

    Site Not Available

  • 41002-Korea University Ansan Hospital

    Ansan,
    Korea, Republic of

    Site Not Available

  • 41001-Inha University Hospital

    Incheon,
    Korea, Republic of

    Site Not Available

  • 41004-Hallym University Kangnam Sacred Heart Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • 41005-Korea University Guro Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • 41003-Ajou University Hospital

    Suwon,
    Korea, Republic of

    Site Not Available

  • 44004-JSC InMedica

    Kaunas,
    Lithuania

    Site Not Available

  • 44004-UAB InMedica

    Kaunas,
    Lithuania

    Site Not Available

  • 44008-JSC Saulės Šeimos Medicinos Centras

    Kaunas,
    Lithuania

    Site Not Available

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

    Kaunas,
    Lithuania

    Site Not Available

  • 44010-InlitaJSC Santara CTC

    Vilnius,
    Lithuania

    Site Not Available

  • 52802-Emotional Brain BV

    Almere,
    Netherlands

    Site Not Available

  • 52804-Universitair Medisch Centrum (UMC) Utrecht - Julius Center for Health Sciences and Primary Care

    Utrecht,
    Netherlands

    Site Not Available

  • 55404-Optimal Clinical Trials - Central

    Grafton,
    New Zealand

    Active - Recruiting

  • 55402-Momentum Clinical Research Wellington

    Mount Cook,
    New Zealand

    Active - Recruiting

  • 55405-Pacific Clinical Research Network - West Auckland

    New Lynn,
    New Zealand

    Active - Recruiting

  • 55401-PCRN - Auckland

    Takapuna,
    New Zealand

    Active - Recruiting

  • 60812-Health Index Multispecialty and Lying-In Clinic

    Bacoor,
    Philippines

    Site Not Available

  • 60804-St. Michael Family Hospital

    Bulacan,
    Philippines

    Site Not Available

  • 60813-Norzel Medical and Diagnostic Clinic

    Cebu,
    Philippines

    Site Not Available

  • 60808-CT CARE Group

    Dasmariñas,
    Philippines

    Site Not Available

  • 60801-Davao Doctors Hospital

    Davao City,
    Philippines

    Site Not Available

  • 60802-West Visayas State University Medical Center

    Iloilo City,
    Philippines

    Site Not Available

  • 60815-St Paul's Hospital Iloilo

    Iloilo City,
    Philippines

    Site Not Available

  • 60816-St Paul's Hospital Iloilo

    Iloilo City,
    Philippines

    Site Not Available

  • 60803-Philippine General Hospital

    Manila,
    Philippines

    Site Not Available

  • 60811-Philippine General Hospital

    Manila,
    Philippines

    Site Not Available

  • 60814-Manila Doctors Hospital

    Manila,
    Philippines

    Site Not Available

  • 60805-San Juan de Dios Hospital

    Pasay,
    Philippines

    Site Not Available

  • 60806-Quirino Memorial Medical Center

    Quezon City,
    Philippines

    Site Not Available

  • 60817-Silang Specialist Medical Center

    Silang,
    Philippines

    Site Not Available

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

    Kraków,
    Poland

    Site Not Available

  • 61622-KOMED Nova Lublin II

    Lublin,
    Poland

    Site Not Available

  • 61620-KOMED Nova Pulawy

    Puławy,
    Poland

    Site Not Available

  • 61605-RCMed Oddzial Sochaczew

    Sochaczew,
    Poland

    Site Not Available

  • 61614-KO-MED Centra Kliniczne Staszow

    Staszów,
    Poland

    Site Not Available

  • 61615-ETG Warszawa

    Warsaw,
    Poland

    Site Not Available

  • 61616-FutureMeds Targowek

    Warsaw,
    Poland

    Site Not Available

  • 61616-MTZ Clinical Research

    Warsaw,
    Poland

    Site Not Available

  • 61605-RCMed Oddział Warszawa

    Warszawa,
    Poland

    Site Not Available

  • 61621-Futuremed Warszawa Centrum

    Warszawa,
    Poland

    Site Not Available

  • 61617-FutureMeds Sp. z o.o.

    Wrocław,
    Poland

    Site Not Available

  • 61617-Przychodnia FutureMeds Wroclaw

    Wrocław,
    Poland

    Site Not Available

  • 61623-KOMED Nova Zamosc

    Zamość,
    Poland

    Site Not Available

  • 61618-Centrum Medyczne AMED Oddzial w Lodzi

    Łódź,
    Poland

    Site Not Available

  • 61618-FutureMeds Lodz

    Łódź,
    Poland

    Site Not Available

  • 64210-Sana Monitoring

    Bucuresti,
    Romania

    Site Not Available

  • 64208-Spitalul Municipal Caracal

    Caracal,
    Romania

    Site Not Available

  • 64204-Ames Research Center

    Călăraşi,
    Romania

    Site Not Available

  • 64209-Clintrial Medical Center

    Reșca,
    Romania

    Site Not Available

  • 64211-Nova-Clin Medical Research Center

    Timişoara,
    Romania

    Site Not Available

  • 71007-Josha Research Center

    Bloemfontein,
    South Africa

    Site Not Available

  • 71008-Madibeng Centre for Research

    Brits,
    South Africa

    Active - Recruiting

  • 71011-University of Cape Town Lung Institute

    Cape Town,
    South Africa

    Active - Recruiting

  • 71014-TREAD Research

    Cape Town,
    South Africa

    Active - Recruiting

  • 71015-Tiervlei Trial Centre

    Cape Town,
    South Africa

    Active - Recruiting

  • 71001-Ubuntu Clinical Research Krugersdorp

    Krugersdorp,
    South Africa

    Active - Recruiting

  • 71001-Ubuntuclinical Research (Krugersdorp)

    Krugersdorp,
    South Africa

    Site Not Available

  • 71010-Merclinico Middelburg

    Middelburg,
    South Africa

    Active - Recruiting

  • 71009-Newtown Clinical Research Centre

    Newtown,
    South Africa

    Active - Recruiting

  • 71005-Be Part Research

    Paarl,
    South Africa

    Site Not Available

  • 71003-Limpopo Clinical Research Initiative

    Thabazimbi,
    South Africa

    Site Not Available

  • 71004-FCRN Clinical Trials Centre

    Vereeniging,
    South Africa

    Active - Recruiting

  • 72402-EAP Vic - CAP El Remei

    Barcelona,
    Spain

    Site Not Available

  • 72407-Futurmeds Spain Cadiz

    Cadiz,
    Spain

    Site Not Available

  • 72405-Futuremeds Spain Madrid

    Madrid,
    Spain

    Site Not Available

  • 72404-Hospital Universitario Son Espases

    Palma de Mallorca,
    Spain

    Site Not Available

  • 72403-Complexo Hospitalario Universitario De Santiago

    Santiago De Compostela,
    Spain

    Site Not Available

  • 72406-Futuremeds Spain Sevilla

    Sevilla,
    Spain

    Site Not Available

  • 72401-Hospital Povisa

    Vigo,
    Spain

    Site Not Available

  • 15803-Taipei Medical University - Shuang Ho Hospital

    New Taipei City,
    Taiwan

    Site Not Available

  • 15801-China Medical University Hospital

    Taichung,
    Taiwan

    Site Not Available

  • 15802-National Cheng Kung University Hospital

    Tainan,
    Taiwan

    Site Not Available

  • 15804-Taipei Medical University - Wanfang Hospital

    Taipei,
    Taiwan

    Site Not Available

  • 15805-Taipei Medical University

    Taipei,
    Taiwan

    Site Not Available

  • 15805-Taipei Medical University - Taipei Medical University Hospital

    Taipei,
    Taiwan

    Site Not Available

  • 79202 - Ankara University Faculty of Medicine

    Ankara, 06620
    Turkey

    Site Not Available

  • 79209 - Hacettepe University Faculty of Medicine

    Ankara, 06230
    Turkey

    Site Not Available

  • 79209-Hacettepe University Faculty of Medicine

    Ankara,
    Turkey

    Site Not Available

  • 79207 - Akdeniz University Faculty of Medicine

    Antalya, 07070
    Turkey

    Site Not Available

  • 79207-Akdeniz University Faculty of Medicine

    Antalya,
    Turkey

    Site Not Available

  • 79212 - Dicle University Faculty of Medicine

    Diyarbakir, 21280
    Turkey

    Site Not Available

  • 79212-Dicle Universitesi Tip Fakultesi

    Diyarbakır,
    Turkey

    Site Not Available

  • 79201 - Liv Hospital Vadistanbul

    Istanbul, 34396
    Turkey

    Site Not Available

  • 79203 - Acibadem Atakent Hospital

    Istanbul, 61080
    Turkey

    Site Not Available

  • 79205 - Goztepe Suleyman Yalcin City Hospital

    Istanbul, 34722
    Turkey

    Site Not Available

  • 79205-Goztepe Suleyman Yalcin City Hospital

    Istanbul,
    Turkey

    Site Not Available

  • 79208 - Izmir Dr. Suat Seren Pulmonary Hospital

    Izmir, 35110
    Turkey

    Site Not Available

  • 79204 - Kocaeli University Faculty of Medicine

    Kocaeli, 41380
    Turkey

    Site Not Available

  • 79206 - Ondokuz Mayis University Faculty of Medicine

    Samsun, 55270
    Turkey

    Site Not Available

  • 79211 - Karadeniz Technical University Faculty of Medicine

    Trabzon, 61080
    Turkey

    Site Not Available

  • 79211-Karadeniz Technical University Faculty of Medicine

    Trabzon,
    Turkey

    Site Not Available

  • 791210-Dokuz Eylul University Faculty of Medicine

    İzmir,
    Turkey

    Site Not Available

  • 79208-Izmir Dr. Suat Seren Pulmonary Hospital

    İzmir,
    Turkey

    Site Not Available

  • 79210 - Dokuz Eylul University Faculty of Medicine

    İzmir, 35340
    Turkey

    Site Not Available

  • 79213 - Ege University Faculty of Medicine

    İzmir, 35100
    Turkey

    Site Not Available

  • 79213-Ege University Hospital

    İzmir,
    Turkey

    Site Not Available

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

    Harare,
    Zimbabwe

    Site Not Available

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