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
- Conditions
- Influenza, Human
- Interventions
- Biological: QIV or TIVBiological: aQIV or aTIV
- Registration Number
- NCT06087640
- Lead Sponsor
- Seqirus
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 35800
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.
In order to participate in this study, all subjects must not meet any of the exclusion criteria described below:
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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.
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Receipt of any influenza vaccine within 6 months prior to enrollment or any plan to receive influenza vaccine while participating in the study.
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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.
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Known history of Guillain-Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis.
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Clinical conditions representing a contra-indication to intramuscular administration of vaccines or blood draw.
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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.
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Receipt of immunoglobulins or any blood products within 180 days prior to informed consent.
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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.
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Acute (severe) febrile illness.
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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.
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Study personnel or immediate family members (brother, sister, child, parent) or the spouse of study personnel.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Non-adjuvanted influenza vaccine QIV or TIV 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 MF59-adjuvanted influenza vaccine aQIV or aTIV 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
- Primary Outcome Measures
Name Time Method 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 Northern Hemisphere [NH] influenza season and end of November for Southern Hemisphere [SH] influenza season) ILI = influenza-like illness; RT-PCR = reverse transcription-polymerase chain reaction
- Secondary Outcome Measures
Name Time Method Efficacy Endpoint: First-occurrence of 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 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) Immunogenicity Endpoint: GMT ratios (adjuvanted/non-adjuvanted) at Day 1 and Day 22 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 Day 1 and Day 22 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.
Safety Endpoint: All adverse events (AEs) reported within 30 minutes after vaccination Day 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 modified CDC 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) CDC = Centers for Disease Control and Prevention
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 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 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) WHO = World Health Organization
Efficacy Endpoint: First-occurrence of 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) 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 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: 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: 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 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
Trial Locations
- Locations (114)
10007-Medical Center Hera EOOD
🇧🇬Montana, Bulgaria
10016-Medical Center 1 - Sevlievo EOOD
🇧🇬Sevlievo, Bulgaria
10023-DCC-1 Sliven
🇧🇬Sliven, 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
20307-CCR Brno s.r.o.
🇨🇿Brno, Czechia
20310-MUDr. Jakub Strincl, s.r.o.
🇨🇿Liberec, Czechia
20309-CCR Ostrava, s.r.o.
🇨🇿Ostrava, Czechia
20308-MUDr. Jakub Strincl, s.r.o.
🇨🇿Protivin, Czechia
20312-MEDISON s.r.o.
🇨🇿Přeštice, Czechia
61616-MTZ Clinical Research
🇵🇱Warsaw, Poland
61605-RCMed Oddział Warszawa
🇵🇱Warszawa, Poland
61621-Futuremed Warszawa Centrum
🇵🇱Warszawa, Poland
61617-Przychodnia FutureMeds Wroclaw
🇵🇱Wrocław, Poland
61623-KOMED Nova Zamosc
🇵🇱Zamość, Poland
61618-Centrum Medyczne AMED Oddzial w Lodzi
🇵🇱Łódź, Poland
64210-Sana Monitoring
🇷🇴Bucuresti, Romania
64208-Spitalul Municipal Caracal
🇷🇴Caracal, Romania
64204-Ames Research Center
🇷🇴Călăraşi, Romania
64209-Clintrial Medical Center
🇷🇴Reșca, Romania
64211-Nova-Clin Medical Research Center
🇷🇴Timişoara, Romania
71007-Josha Research Center
🇿🇦Bloemfontein, South Africa
71011-University of Cape Town Lung Institute
🇿🇦Cape Town, South Africa
71014-TREAD Research
🇿🇦Cape Town, South Africa
71015-Tiervlei Trial Centre
🇿🇦Cape Town, South Africa
71001-Ubuntuclinical Research (Krugersdorp)
🇿🇦Krugersdorp, South Africa
71005-Be Part Research
🇿🇦Paarl, South Africa
71003-Limpopo Clinical Research Initiative
🇿🇦Thabazimbi, South Africa
72402-EAP Vic - CAP El Remei
🇪🇸Barcelona, Spain
72407-Futurmeds Spain Cadiz
🇪🇸Cadiz, Spain
72405-Futuremeds Spain Madrid
🇪🇸Madrid, Spain
05605-AZ Sint-Jan Brugge-Oostende - Campus Sint-Jan
🇧🇪Brugge, Belgium
05602-Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
05603-Medif BVBA
🇧🇪Gozée, Belgium
05601-Jan Yperman Ziekenhuis
🇧🇪Ypres, Belgium
10005-MHAT Dr. Tota Venkova
🇧🇬Gabrovo, Bulgaria
10018-Medical Center - Zdrave-1
🇧🇬Kozloduy, Bulgaria
10029-Medical Centre Leo Clinic EOOD
🇧🇬Lovech, Bulgaria
61620-KOMED Nova Pulawy
🇵🇱Puławy, Poland
61614-KO-MED Centra Kliniczne Staszow
🇵🇱Staszów, Poland
60808-CT CARE Group
🇵🇭Dasmariñas, Philippines
60801-Davao Doctors Hospital
🇵🇭Davao City, Philippines
60802-West Visayas State University Medical Center
🇵🇭Iloilo City, Philippines
41002-Korea University Ansan Hospital
🇰🇷Ansan, Korea, Republic of
60815-St Paul's Hospital Iloilo
🇵🇭Iloilo City, Philippines
41001-Inha University Hospital
🇰🇷Incheon, Korea, Republic of
60816-St Paul's Hospital Iloilo
🇵🇭Iloilo City, Philippines
60803-Philippine General Hospital
🇵🇭Manila, Philippines
60811-Philippine General Hospital
🇵🇭Manila, Philippines
41004-Hallym University Kangnam Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
60814-Manila Doctors Hospital
🇵🇭Manila, Philippines
41005-Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
41003-Ajou University Hospital
🇰🇷Suwon, Korea, Republic of
60805-San Juan de Dios Hospital
🇵🇭Pasay, Philippines
44004-JSC InMedica
🇱🇹Kaunas, Lithuania
60806-Quirino Memorial Medical Center
🇵🇭Quezon City, Philippines
60817-Silang Specialist Medical Center
🇵🇭Silang, Philippines
61615-ETG Warszawa
🇵🇱Warsaw, Poland
26803-UNIMED Adjara LTD - Batumi Referral Hospital
🇬🇪Batumi, Georgia
61619-Krakowskie Centrum Medyczne Sp. z o.o
🇵🇱Kraków, Poland
61622-KOMED Nova Lublin II
🇵🇱Lublin, Poland
26801-LTD Hospital Service
🇬🇪Kutaisi, Georgia
26802-Acad. G. Chapidze Emergency Cardiology Center
🇬🇪Tbilisi, Georgia
26804-K. Eristavi National Center of Clinical Surgery
🇬🇪Tbilisi, Georgia
38003-Policlinico Bari
🇮🇹Bari, Italy
38001-PO A. Manzoni di Lecco, ASST Lecco
🇮🇹Lecco, Italy
38004-Ospedale Fatebenefratelli e Oftalmico, ASST Fatebenefratelli Sacco
🇮🇹Milano, Italy
10014-Multi-Profile Hospital For Active Treatment Dr. Stamen Iliev AD
🇧🇬Montana, Bulgaria
10032-MHAT Zdrave
🇧🇬Pazardzhik, Bulgaria
10019-MC Med Consult Pleven
🇧🇬Pleven, Bulgaria
10022-Ambulatory Outpatient Medical Practice for First Patient Care Zaprin Pepelov
🇧🇬Plovdiv, Bulgaria
10024-UMHAT Pulmed
🇧🇬Plovdiv, Bulgaria
10026-Multiprofile Hospital for Active Treatment Sv. Panteleymon - Plovdiv
🇧🇬Plovdiv, Bulgaria
10031-Medical Centre Pratia Clinic EOOD
🇧🇬Plovdiv, Bulgaria
10004-Medical Center Prolet EOOD
🇧🇬Ruse, Bulgaria
10012-Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov-Ruse EOOD
🇧🇬Ruse, Bulgaria
10030-Diagnostic-Consultative Centre Ascendent EOOD
🇧🇬Sofia, Bulgaria
10027-AIPPMP D-r Zhaneta Demireva
🇧🇬Stamboliyski, Bulgaria
20305-Centrum ockovani a cestovni mediciny
🇨🇿České Budějovice, Czechia
20306-ADMED, s.r.o.
🇨🇿České Budějovice, Czechia
20311-Ordinace Hradebni s.r.o
🇨🇿České Budějovice, Czechia
24603-Helsinki South Vaccine Research Clinic
🇫🇮Helsinki, Finland
24602-Oulu Vaccine Research Clinic
🇫🇮Oulu, Finland
24601-Tampere Vaccine Research Clinic
🇫🇮Tampere, Finland
24604-Turku Vaccine Research Clinic
🇫🇮Turku, Finland
44008-JSC Saulės Šeimos Medicinos Centras
🇱🇹Kaunas, Lithuania
44009-Hospital of Lithuanian University of Health Sciences Kauno klinikos
🇱🇹Kaunas, Lithuania
44010-InlitaJSC Santara CTC
🇱🇹Vilnius, Lithuania
52802-Emotional Brain BV
🇳🇱Almere, Netherlands
52804-Universitair Medisch Centrum (UMC) Utrecht - Julius Center for Health Sciences and Primary Care
🇳🇱Utrecht, Netherlands
60812-Health Index Multispecialty and Lying-In Clinic
🇵🇭Bacoor, Philippines
60804-St. Michael Family Hospital
🇵🇭Bulacan, Philippines
60813-Norzel Medical and Diagnostic Clinic
🇵🇭Cebu, Philippines
72404-Hospital Universitario Son Espases
🇪🇸Palma de Mallorca, Spain
72403-Complexo Hospitalario Universitario De Santiago
🇪🇸Santiago De Compostela, Spain
72406-Futuremeds Spain Sevilla
🇪🇸Sevilla, Spain
72401-Hospital Povisa
🇪🇸Vigo, Spain
15803-Taipei Medical University - Shuang Ho Hospital
🇨🇳New Taipei City, Taiwan
15801-China Medical University Hospital
🇨🇳Taichung, Taiwan
15802-National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
15804-Taipei Medical University - Wanfang Hospital
🇨🇳Taipei, Taiwan
15805-Taipei Medical University
🇨🇳Taipei, Taiwan
79209-Hacettepe University Faculty of Medicine
🇹🇷Ankara, Turkey
79207-Akdeniz University Faculty of Medicine
🇹🇷Antalya, Turkey
79212-Dicle Universitesi Tip Fakultesi
🇹🇷Diyarbakır, Turkey
79205-Goztepe Suleyman Yalcin City Hospital
🇹🇷Istanbul, Turkey
791210-Dokuz Eylul University Faculty of Medicine
🇹🇷İzmir, Turkey
79208-Izmir Dr. Suat Seren Pulmonary Hospital
🇹🇷İzmir, Turkey
79213-Ege University Hospital
🇹🇷İzmir, Turkey
79204 - Kocaeli University Faculty of Medicine
🇹🇷Kocaeli, Turkey
79211-Karadeniz Technical University Faculty of Medicine
🇹🇷Trabzon, Turkey
71601-Charles River Medical Group, Mutala Trust and Infectious Disease Research Laboratory
🇿🇼Harare, Zimbabwe