Influenza, Human

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

NCT06087640 | PHASE 3 | INTERVENTIONAL

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.

90 Sites

35800 Participants

Recruiting

65 Years to 65 Years

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Find closest sites:

SUBMIT

Universitair Ziekenhuis Gent

Gent,Belgium

ResearchLink

Linkebeek,Belgium

MHAT Dr. Tota Venkova

Gabrovo,Bulgaria

Medical Center Zdrave

Kozloduy,Bulgaria

Medical Centre Leo Clinic EOOD

Lovech,Bulgaria

Medical Center Hera EOOD

Montana,Bulgaria

MultiProfile Hospital For Active Treatment Dr. Stamen Iliev AD

Montana,Bulgaria

MC Med Consult Pleven

Pleven,Bulgaria

Ambulatory Outpatient Medical Practice for First Patient Care Zaprin Pepelov

Plovdiv,Bulgaria

Multiprofile Hospital for Active Treatment Sv. Panteleymon Plovdiv

Plovdiv,Bulgaria

Medical Center Prolet EOOD

Ruse,Bulgaria

Specialized Hospital For Active Treatment Of PneumoPhthisiatric Diseases Dr. Dimitar GramatikovRuse EOOD

Ruse,Bulgaria

Diagnostic Consultative Center Sevlievo EOOD

Sevlievo,Bulgaria

DCC Sliven

Sliven,Bulgaria

DCC Sofia

Sofia,Bulgaria

Medical Center Hera Pulmonology Office

Sofia,Bulgaria

Medical Center Intermedica

Sofia,Bulgaria

Medical Center Excelsior OOD

Sofia,Bulgaria

AIPPMP Dr Zhaneta Demireva

Stamboliyski,Bulgaria

CCR Brno s.r.o.

Brno,Czechia

MUDr. Jakub Strincl, s.r.o.

Liberec,Czechia

CCR Ostrava, s.r.o.

Ostrava,Czechia

Zdravi fit, s.r.o.

Protivín,Czechia

Prof. MUDr. Jiri Beran, s.r.o.

České Budějovice,Czechia

ADMED, s.r.o.

České Budějovice,Czechia

Oulu Vaccine Research Clinic

Oulu,Finland

Tampere Vaccine Research Clinic

Tampere,Finland

Turku Vaccine Research Clinic

Turku,Finland

JSC Evex Hospitals

Batumi,Georgia

LTD Hospital Service

Kutaisi,Georgia

Acad. G. Chapidze Emergency Cardiology Center

Tbilisi,Georgia

K. Eristavi National Center of Clinical Surgery

Tbilisi,Georgia

University Hospital Consorziale Policlinico

Bari,Italy

PO A. Manzoni di Lecco, ASST Lecco

Lecco,Italy

Ospedale Fatebenefratelli e Oftalmico, ASST Fatebenefratelli Sacco

Milano,Italy

Korea University Ansan Hospital

Ansan,Korea, Republic of

Inha University Hospital

Incheon,Korea, Republic of

Hallym University Kangnam Sacred Heart Hospital

Seoul,Korea, Republic of

Ajou University Hospital

Suwon,Korea, Republic of

UAB InMedica

Kaunas,Lithuania

JSC Sauls eimos Medicinos Centras

Kaunas,Lithuania

Hospital of Lithuanian University of Health Sciences Kauno klinikos

Kaunas,Lithuania

InlitaJSC Santara CTC

Vilnius,Lithuania

Emotional Brain BV

Almere,Netherlands

Health Index Multispecialty and LyingIn Clinic

Bacoor,Philippines

St. Michael Family Hospital

Bulacan,Philippines

Norzel Medical and Diagnostic Clinic

Cebu,Philippines

CT CARE Group

Dasmariñas,Philippines

Davao Doctors Hospital

Davao City,Philippines

West Visayas State University Medical Center

Iloilo City,Philippines

St Paul's Hospital Iloilo

Iloilo City,Philippines

St Paul's Hospital Iloilo

Iloilo City,Philippines

Philippine General Hospital

Manila,Philippines

Philippine General Hospital

Manila,Philippines

Manila Doctors Hospital

Manila,Philippines

San Juan de Dios Hospital

Pasay,Philippines

Quirino Memorial Medical Center

Quezon City,Philippines

Silang Specialist Medical Center

Silang,Philippines

RCMed Oddzial Sochaczew

Sochaczew,Poland

KOMED Centra Kliniczne Staszow

Staszów,Poland

ETG Warszawa

Warsaw,Poland

FutureMeds Targowek

Warsaw,Poland

FutureMeds Sp. z o.o.

Wrocław,Poland

FutureMeds Lodz

Łódź,Poland

Sana Monitoring

Bucuresti,Romania

Ames Research Center

Călăraşi,Romania

Clintrial Medical Center

Reșca,Romania

NovaClin Medical Research Center

Timişoara,Romania

Josha Research Center

Bloemfontein,South Africa

University of Cape Town Lung Institute

Cape Town,South Africa

TREAD Research

Cape Town,South Africa

Tiervlei Trial Centre

Cape Town,South Africa

Ubuntuclinical Research (Krugersdorp)

Krugersdorp,South Africa

Be Part Research

Paarl,South Africa

Limpopo Clinical Research Initiative

Thabazimbi,South Africa

EAP Vic CAP El Remei

Barcelona,Spain

Hospital Universitario Son Espases

Palma de Mallorca,Spain

Hospital Povisa

Vigo,Spain

Taipei Medical University Shuang Ho Hospital

New Taipei City,Taiwan

China Medical University Hospital

Taichung,Taiwan

National Cheng Kung University Hospital

Tainan,Taiwan

Taipei Medical University Wanfang Hospital

Taipei,Taiwan

Taipei Medical University Taipei Medical University Hospital

Taipei,Taiwan

Hacettepe University Faculty of Medicine

Ankara,Turkey

Akdeniz University Faculty of Medicine

Antalya,Turkey

Dicle Universitesi Tip Fakultesi

Diyarbakır,Turkey

Goztepe Suleyman Yalcin City Hospital

Istanbul,Turkey

Kocaeli University Faculty of Medicine

Kocaeli,Turkey,41380

Karadeniz Technical University Faculty of Medicine

Trabzon,Turkey

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

Harare,Zimbabwe

Study Eligibility Criteria

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.

Additional Studies

Additional studies can be found at ClinicalTrials.gov