Clinical trial NCT06087640: 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
Official title: A Phase 3/3b, Randomized, Observer-blind, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Subunit Inactivated Influenza Vaccine Compared to a Non-adjuvanted Influenza Vaccine in Adults ≥65 Years of Age
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Influenza, Human
Keywords: Influenza
Vaccine
MF59 adjuvant
aQIV
aTIV
A/H1N1
A/H3N2
B/Yamagata
B/Victoria
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
First posted: 2023-10-18
Enrollment: 35800
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
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
timeFrame: 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:
measure: 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
timeFrame: 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)
measure: 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
timeFrame: 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)
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 modified CDC ILI definition
timeFrame: 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)
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 WHO ILI definition
timeFrame: 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)
measure: 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
timeFrame: 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)
measure: 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
timeFrame: Day 1 and Day 22
measure: 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
timeFrame: Day 1 and Day 22
measure: Immunogenicity Endpoint: Geometric mean fold increase (GMFI, Day 22/Day1) for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains
timeFrame: Day 1 and Day 22
measure: Immunogenicity Endpoint: Percentage of subjects achieving seroconversion for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains
timeFrame: Day 1 and Day 22
measure: Immunogenicity Endpoint: Percentage of subjects with HI titer ≥1:40 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains
timeFrame: Day 1 and Day 22
measure: Safety Endpoint: All adverse events (AEs) reported within 30 minutes after vaccination
timeFrame: Day 1
measure: Safety Endpoint: Serious adverse events (SAEs) reported during the entire study period
timeFrame: Day 1 to Day 181 or the end of the influenza season, whichever is longer
measure: Safety Endpoint: Adverse events of special interest (AESIs) reported during the entire study period
timeFrame: Day 1 to Day 181 or the end of the influenza season, whichever is longer
measure: Safety Endpoint: AEs leading to premature withdrawal from the study during the entire study period
timeFrame: Day 1 to Day 181 or the end of the influenza season, whichever is longer
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: 05605-AZ Sint-Jan Brugge-Oostende - Campus Sint-Jan
city: Gent
country: Belgium
facility: 05602-Universitair Ziekenhuis Gent
city: Gozée
country: Belgium
facility: 05603-Medif BVBA
city: Ypres
country: Belgium
facility: 05601-Jan Yperman Ziekenhuis
city: Gabrovo
country: Bulgaria
facility: 10005-MHAT Dr. Tota Venkova
city: Kozloduy
country: Bulgaria
facility: 10018-Medical Center - Zdrave-1
city: Lovech
country: Bulgaria
facility: 10029-Medical Centre Leo Clinic EOOD
city: Montana
country: Bulgaria
facility: 10007-Medical Center Hera EOOD
city: Montana
country: Bulgaria
facility: 10014-Multi-Profile Hospital For Active Treatment Dr. Stamen Iliev AD
city: Pazardzhik
country: Bulgaria
facility: 10032-MHAT Zdrave
city: Pleven
country: Bulgaria
facility: 10019-MC Med Consult Pleven
city: Plovdiv
country: Bulgaria
facility: 10022-Ambulatory Outpatient Medical Practice for First Patient Care Zaprin Pepelov
city: Plovdiv
country: Bulgaria
facility: 10024-UMHAT Pulmed
city: Plovdiv
country: Bulgaria
facility: 10026-Multiprofile Hospital for Active Treatment Sv. Panteleymon - Plovdiv
city: Plovdiv
country: Bulgaria
facility: 10031-Medical Centre Pratia Clinic EOOD
city: Ruse
country: Bulgaria
facility: 10004-Medical Center Prolet EOOD
city: Ruse
country: Bulgaria
facility: 10012-Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov-Ruse EOOD
city: Sevlievo
country: Bulgaria
facility: 10016-Medical Center 1 - Sevlievo EOOD
city: Sliven
country: Bulgaria
facility: 10023-DCC-1 Sliven
city: Sofia
country: Bulgaria
facility: 10006-DCC 22 - Sofia
city: Sofia
country: Bulgaria
facility: 10015-Medical Center Hera - Pulmonology Office
city: Sofia
country: Bulgaria
facility: 10021-Medical Center Intermedica
city: Sofia
country: Bulgaria
facility: 10028-Medical Center Excelsior OOD
city: Sofia
country: Bulgaria
facility: 10030-Diagnostic-Consultative Centre Ascendent EOOD
city: Stamboliyski
country: Bulgaria
facility: 10027-AIPPMP D-r Zhaneta Demireva
city: Brno
country: Czechia
facility: 20307-CCR Brno s.r.o.
city: Liberec
country: Czechia
facility: 20310-MUDr. Jakub Strincl, s.r.o.
city: Ostrava
country: Czechia
facility: 20309-CCR Ostrava, s.r.o.
city: Protivin
country: Czechia
facility: 20308-MUDr. Jakub Strincl, s.r.o.
city: Přeštice
country: Czechia
facility: 20312-MEDISON s.r.o.
city: České Budějovice
country: Czechia
facility: 20305-Centrum ockovani a cestovni mediciny
city: České Budějovice
country: Czechia
facility: 20306-ADMED, s.r.o.
city: České Budějovice
country: Czechia
facility: 20311-Ordinace Hradebni s.r.o
city: Helsinki
country: Finland
facility: 24603-Helsinki South Vaccine Research Clinic
city: Oulu
country: Finland
facility: 24602-Oulu Vaccine Research Clinic
city: Tampere
country: Finland
facility: 24601-Tampere Vaccine Research Clinic
city: Turku
country: Finland
facility: 24604-Turku Vaccine Research Clinic
city: Batumi
country: Georgia
facility: 26803-UNIMED Adjara LTD - Batumi Referral Hospital
city: Kutaisi
country: Georgia
facility: 26801-LTD Hospital Service
city: Tbilisi
country: Georgia
facility: 26802-Acad. G. Chapidze Emergency Cardiology Center
city: Tbilisi
country: Georgia
facility: 26804-K. Eristavi National Center of Clinical Surgery
city: Bari
country: Italy
facility: 38003-Policlinico Bari
city: Lecco
country: Italy
facility: 38001-PO A. Manzoni di Lecco, ASST Lecco
city: Milano
country: Italy
facility: 38004-Ospedale Fatebenefratelli e Oftalmico, ASST Fatebenefratelli Sacco
city: Ansan
country: Korea, Republic of
facility: 41002-Korea University Ansan Hospital
city: Incheon
country: Korea, Republic of
facility: 41001-Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: 41004-Hallym University Kangnam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: 41005-Korea University Guro Hospital
city: Suwon
country: Korea, Republic of
facility: 41003-Ajou University Hospital
city: Kaunas
country: Lithuania
facility: 44004-JSC InMedica
city: Kaunas
country: Lithuania
facility: 44008-JSC Saulės Šeimos Medicinos Centras
city: Kaunas
country: Lithuania
facility: 44009-Hospital of Lithuanian University of Health Sciences Kauno klinikos
city: Vilnius
country: Lithuania
facility: 44010-InlitaJSC Santara CTC
city: Almere
country: Netherlands
facility: 52802-Emotional Brain BV
city: Utrecht
country: Netherlands
facility: 52804-Universitair Medisch Centrum (UMC) Utrecht - Julius Center for Health Sciences and Primary Care
city: Bacoor
country: Philippines
facility: 60812-Health Index Multispecialty and Lying-In Clinic
city: Bulacan
country: Philippines
facility: 60804-St. Michael Family Hospital
city: Cebu
country: Philippines
facility: 60813-Norzel Medical and Diagnostic Clinic
city: Dasmariñas
country: Philippines
facility: 60808-CT CARE Group
city: Davao City
country: Philippines
facility: 60801-Davao Doctors Hospital
city: Iloilo City
country: Philippines
facility: 60802-West Visayas State University Medical Center
city: Iloilo City
country: Philippines
facility: 60815-St Paul's Hospital Iloilo
city: Iloilo City
country: Philippines
facility: 60816-St Paul's Hospital Iloilo
city: Manila
country: Philippines
facility: 60803-Philippine General Hospital
city: Manila
country: Philippines
facility: 60811-Philippine General Hospital
city: Manila
country: Philippines
facility: 60814-Manila Doctors Hospital
city: Pasay
country: Philippines
facility: 60805-San Juan de Dios Hospital
city: Quezon City
country: Philippines
facility: 60806-Quirino Memorial Medical Center
city: Silang
country: Philippines
facility: 60817-Silang Specialist Medical Center
city: Kraków
country: Poland
facility: 61619-Krakowskie Centrum Medyczne Sp. z o.o
city: Lublin
country: Poland
facility: 61622-KOMED Nova Lublin II
city: Puławy
country: Poland
facility: 61620-KOMED Nova Pulawy
city: Staszów
country: Poland
facility: 61614-KO-MED Centra Kliniczne Staszow
city: Warsaw
country: Poland
facility: 61615-ETG Warszawa
city: Warsaw
country: Poland
facility: 61616-MTZ Clinical Research
city: Warszawa
country: Poland
facility: 61605-RCMed Oddział Warszawa
city: Warszawa
country: Poland
facility: 61621-Futuremed Warszawa Centrum
city: Wrocław
country: Poland
facility: 61617-Przychodnia FutureMeds Wroclaw
city: Zamość
country: Poland
facility: 61623-KOMED Nova Zamosc
city: Łódź
country: Poland
facility: 61618-Centrum Medyczne AMED Oddzial w Lodzi
city: Bucuresti
country: Romania
facility: 64210-Sana Monitoring
city: Caracal
country: Romania
facility: 64208-Spitalul Municipal Caracal
city: Călăraşi
country: Romania
facility: 64204-Ames Research Center
city: Reșca
country: Romania
facility: 64209-Clintrial Medical Center
city: Timişoara
country: Romania
facility: 64211-Nova-Clin Medical Research Center
city: Bloemfontein
country: South Africa
facility: 71007-Josha Research Center
city: Cape Town
country: South Africa
facility: 71011-University of Cape Town Lung Institute
city: Cape Town
country: South Africa
facility: 71014-TREAD Research
city: Cape Town
country: South Africa
facility: 71015-Tiervlei Trial Centre
city: Krugersdorp
country: South Africa
facility: 71001-Ubuntuclinical Research (Krugersdorp)
city: Paarl
country: South Africa
facility: 71005-Be Part Research
city: Thabazimbi
country: South Africa
facility: 71003-Limpopo Clinical Research Initiative
city: Barcelona
country: Spain
facility: 72402-EAP Vic - CAP El Remei
city: Cadiz
country: Spain
facility: 72407-Futurmeds Spain Cadiz
city: Madrid
country: Spain
facility: 72405-Futuremeds Spain Madrid
city: Palma de Mallorca
country: Spain
facility: 72404-Hospital Universitario Son Espases
city: Santiago De Compostela
country: Spain
facility: 72403-Complexo Hospitalario Universitario De Santiago
city: Sevilla
country: Spain
facility: 72406-Futuremeds Spain Sevilla
city: Vigo
country: Spain
facility: 72401-Hospital Povisa
city: New Taipei City
country: Taiwan
facility: 15803-Taipei Medical University - Shuang Ho Hospital
city: Taichung
country: Taiwan
facility: 15801-China Medical University Hospital
city: Tainan
country: Taiwan
facility: 15802-National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: 15804-Taipei Medical University - Wanfang Hospital
city: Taipei
country: Taiwan
facility: 15805-Taipei Medical University
city: Ankara
country: Turkey
facility: 79209-Hacettepe University Faculty of Medicine
city: Antalya
country: Turkey
facility: 79207-Akdeniz University Faculty of Medicine
city: Diyarbakır
country: Turkey
facility: 79212-Dicle Universitesi Tip Fakultesi
city: Istanbul
country: Turkey
facility: 79205-Goztepe Suleyman Yalcin City Hospital
city: İzmir
country: Turkey
facility: 791210-Dokuz Eylul University Faculty of Medicine
city: İzmir
country: Turkey
facility: 79208-Izmir Dr. Suat Seren Pulmonary Hospital
city: İzmir
country: Turkey
facility: 79213-Ege University Hospital
city: Kocaeli
country: Turkey
facility: 79204 - Kocaeli University Faculty of Medicine
city: Trabzon
country: Turkey
facility: 79211-Karadeniz Technical University Faculty of Medicine
city: Harare
country: Zimbabwe
facility: 71601-Charles River Medical Group, Mutala Trust and Infectious Disease Research Laboratory
Study officials:
affiliation: Seqirus
name: Clinical Program Director
role: STUDY_DIRECTOR
References: