Clinical trial NCT02587221: Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age
Official title: A Phase III, Randomized, Observer-Blind, Controlled, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
First posted: 2015-10-27
Enrollment: 6790
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A Phase III, Randomized, Observer-Blind, Controlled, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age.


Eligibility criteria: Inclusion Criteria:

1. Males and females ≥ 65 years old who are healthy or have co-morbidities
2. Individuals who or whose legal guardian have voluntarily given written consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
3. Ability to attend all scheduled visits and to comply with study procedures

Exclusion Criteria:

1. Hypersensitivity, including allergy to any component of vaccines foreseen in this study
2. Abnormal function of the immune system.
3. Receipt of any influenza vaccine within 6 months prior to enrolment in this study or who plan to receive influenza vaccine while participating in the study.
4. Additional eligibility criteria may be discussed by contacting the site

Primary outcomes:
measure: Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on RT-PCR-confirmed Influenza Due to Any Strain Using Protocol Defined ILI Definition.
timeFrame: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
measure: Safety Endpoint: The Percentage of Subjects in the Solicited Safety Subset With Solicited Local and Systemic Adverse Events (AE)
timeFrame: Day 1 through Day 7
measure: Safety Endpoint: Percentage of Subjects With Medically-attended Adverse Events (MAAEs)
timeFrame: Within 30 days after of first occurrence RT-PCR confirmed Influenza
measure: Safety Endpoint: Percentages of Subjects With Any Unsolicited AE
timeFrame: Day 1 through Day 366
measure: Safety Endpoint: Percentages of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), and Adverse Events of Special Interest (AESI)
timeFrame: Day 1 to Day 366
Secondary outcomes:
measure: Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on RT-PCR-confirmed Influenza Due to Any Strain Using Modified CDC ILI Definition.
timeFrame: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
measure: Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Matched to the Strains Selected for the Seasonal Vaccine Using Protocol Defined ILI Definition.
timeFrame: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
measure: Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Matched to the Strains Selected for the Seasonal Vaccine Using Modified CDC ILI Definition.
timeFrame: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
measure: Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Regardless of Antigenic Match Using Protocol Defined ILI Definition.
timeFrame: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
measure: Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Regardless of Antigenic Match Using Modified CDC ILI Definition.
timeFrame: Day 7 to Day 180 after vaccination or end of influenza season, whichever is longer
measure: Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Unmatched to the Strains Selected for the Seasonal Vaccine Using Protocol Defined ILI Definition.
timeFrame: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
measure: Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Unmatched to the Strains Selected for the Seasonal Vaccine Using Modified CDC ILI Definition.
timeFrame: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
measure: Immunogenicity Endpoint: Geometric Mean Hemagglutination Inhibition (HI) Titers (GMT)
timeFrame: Days 1 and 22
measure: Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post-vaccination HI Titer Over the Pre-vaccination HI Titer
timeFrame: Day 22/Day 1
measure: Immunogenicity Endpoint: Percentages of Subjects With an HI Titer ≥1:40
timeFrame: Day 22
measure: Immunogenicity Endpoint: Percentages of Subjects Who Achieved Seroconversion (SCR)
timeFrame: Day 22
Other outcomes:
Locations:
city: Dimitrovgrad
country: Bulgaria
facility: MHAT St. Ekaterina
city: Lom
country: Bulgaria
facility: MHAT Sv Nikolay Chudotvoretz Lom
city: Plovdiv
country: Bulgaria
facility: MBAL TRIMONCIUM (Synexus)
city: Ruse
country: Bulgaria
facility: SHATPPD-Ruse
city: Silistra
country: Bulgaria
facility: Mhat Silistra
city: Smolyan
country: Bulgaria
facility: Mc Smolyan
city: Sofia
country: Bulgaria
facility: Mc Avicena Sofia
city: Sofia
country: Bulgaria
facility: Medical Center Excelsior
city: Sofia
country: Bulgaria
facility: Medical center Synexus Sofia EOOD
city: Sofia
country: Bulgaria
facility: SHATPPD-Sofia, City
city: Stara Zagora
country: Bulgaria
facility: Medical Centre Orpheus OOD (Synexus)
city: Medellín
country: Colombia
facility: Hospital General de Medellín-Luz Castro de Gutiérrez - E.S.E
state: Antioquia
city: Bogotá
country: Colombia
facility: Caja de Compesanción Familiar CAFAM
state: Cundinamarca
city: Armenia
country: Colombia
facility: Fundacion Cardiomet CEQUIN - Internal Medicine
city: Barranquilla
country: Colombia
facility: Clinica de la Costa
city: Bogotá
country: Colombia
facility: Centro de Atención e Investigación Médica S.A.S. - CAIMED S.A.S.
city: Bogotá
country: Colombia
facility: Medplus Medicina Prepagada
city: Manizales
country: Colombia
facility: Asociacion IPS Medicos Internistas de Caldas
city: Brno
country: Czechia
facility: CCBR Czech Brno, s.r.o.
city: Hradec Kralove
country: Czechia
facility: FN Hradec Kralove
city: Hradec Králové
country: Czechia
facility: Centrum ockovani a cestovni mediciny
city: Ostrava
country: Czechia
facility: CCBR Ostrava, s.r.o.
city: Pardubice
country: Czechia
facility: CCBR Czech, a.s.
city: Tallinn
country: Estonia
facility: Center for Clinical and Basic Research
state: Harjumaa
city: Tallinn
country: Estonia
facility: Medicum AS
state: Harjumaa
city: Tallinn
country: Estonia
facility: Merelahe Family Doctors Centre
state: Harjumaa
city: Paide
country: Estonia
facility: Vee Family Doctors Centre
state: Järvamaa
city: Tartu
country: Estonia
facility: Clinical Research Center
state: Tartumaa
city: Tartu
country: Estonia
facility: Family Doctors Pullerits & Gavronski
state: Tartumaa
city: Balvi
country: Latvia
facility: Practice Dr Liga Kozlovska
city: Kuldiga
country: Latvia
facility: Practice Dr Ruta Eglite
city: Riga
country: Latvia
facility: Family Doctor Andra Lasmane clinic "ALMA"
city: Tukums
country: Latvia
facility: Practice Dr Inese Petrova
city: Kaunas
country: Lithuania
facility: JSC Saules seimos medicinos centras
city: Kaunas
country: Lithuania
facility: Kauno klinikine ligonine
city: Kaunas
country: Lithuania
facility: Lietuvos Sveikatos Mokslų Universitetas
city: Kaunas
country: Lithuania
facility: UAB InMedica
city: Klaipeda
country: Lithuania
facility: Klaipeda University Hospital
city: Siauliai
country: Lithuania
facility: Republican Siauliai Hospital
city: Vilnius
country: Lithuania
facility: CCBR
city: Alor Setar
country: Malaysia
facility: Hospital Sultanah Bahiyah
city: Batu Caves
country: Malaysia
facility: Hospital Selayang
city: Ipoh
country: Malaysia
facility: Klinik Kesihatan Greentown
city: Kota Bharu
country: Malaysia
facility: Hospital Raja Perempuan Zainab II
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre (UMMC)
city: Seremban
country: Malaysia
facility: Klinik Kesihatan Seremban 2
city: Seri Manjung
country: Malaysia
facility: Hospital Seri Manjung
city: Sibu
country: Malaysia
facility: Hospital Sibu
city: Dasmariñas
country: Philippines
facility: De La Salle Health Sciences Institute
state: Cavite
city: Jaro
country: Philippines
facility: West Visayas State University - Medical Center
state: Iloilo
city: Quezon
country: Philippines
facility: Quirino Memorial Medical Center
state: National Capital Region
city: Bulacan
country: Philippines
facility: Marilao St. Michael Family Hospital
city: Manila
country: Philippines
facility: Philippine General Hospital
city: Pasay
country: Philippines
facility: San Juan De Dios Hospital
city: Wroclaw
country: Poland
facility: Synexus Polska Sp. z o.o.
state: Dolnoslaskie
city: Bydgoszcz
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej VITAMED
state: Kujawsko-pomorskie
city: Plock
country: Poland
facility: NZOZ Centrum Medyczne "OMEGA" sp. z o.o.
state: Mazowieckie
city: Warszawa
country: Poland
facility: Centrum Medyczne Pratia Warszawa
state: Mazowieckie
city: Warszawa
country: Poland
facility: Specjalistyczny Osrodek Medycyny Wieku Dojrzalego
state: Mazowieckie
city: Gdansk
country: Poland
facility: Synexus Polska Sp. z o.o.
state: Pomorskie
city: Gdynia
country: Poland
facility: Centrum Medyczne Pratia Gdynia
state: Pomorskie
city: Katowice
country: Poland
facility: Centrum Medyczne Pratia Katowice
state: Slaskie
city: Katowice
country: Poland
facility: Praktyka Lekarzy Rodzinnych SALUS
state: Slaskie
city: Poznan
country: Poland
facility: Synexus Polska Sp. z o.o
state: Wielkopolskie
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne PRATIA Bydgoszcz
city: Lodz
country: Poland
facility: Specjalistyczny Osrodek Medycyny Wieku Dojrzalego sp. z o.o.
city: Nowy Duninow
country: Poland
facility: RCMed Oddział Nowy Duninow
city: Sochaczew
country: Poland
facility: RCMed Oddzial Sochaczew
city: Torun
country: Poland
facility: Medical Trials Institute
city: Arad
country: Romania
facility: Cabinet dr. Dana OLAR
city: Brasov
country: Romania
facility: Centrul Medical de Diagnostic si Tratament Ambulator NEOMED
city: Bucuresti
country: Romania
facility: Cabinet Medical Individual Craciun-Nicodin Maria Marcela
city: Bucuresti
country: Romania
facility: Centrul Medical Sana
city: Bucuresti
country: Romania
facility: Clinica Medicala Synexus
city: Cluj
country: Romania
facility: Spitalul Clinic C.F. Cluj-Napoca
city: Resca
country: Romania
facility: Clintrial Medical Center
city: Timisoara
country: Romania
facility: Fundatia Cardioprevent
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
city: Bangkok
country: Thailand
facility: Mahidol University (MU) - Faculty of Tropical Medicine
city: Khon Kaen
country: Thailand
facility: Khon Kaen University - Srinagarind Hospital - Medicine
city: Mueang Nonthaburi
country: Thailand
facility: Bamrasnaradura Infectious Diseases Institute (BIDI)
city: Ankara
country: Turkey
facility: Ankara Training and Research Hospital
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty
city: Antalya
country: Turkey
facility: Akdeniz University Medical Faculty
city: Cerrahpaşa
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty
city: Erzurum
country: Turkey
facility: Ataturk University Medical Faculty
city: Izmir
country: Turkey
facility: Ege University Medical Faculty
city: Kocaeli
country: Turkey
facility: Kocaeli University Research and Application Hospital
city: Sakarya
country: Turkey
facility: Sakarya Training and Research Hospital
Study officials:
affiliation: Seqirus
name: Clinical Program Manager
role: STUDY_DIRECTOR
References:
citation: Beran J, Reynales H, Poder A, Yu CY, Pitisuttithum P, Yuan LL, Vermeulen W, Verhoeven C, Leav B, Zhang B, Sawlwin D, Hamers-Heijnen E, Edelman J, Smolenov I. Prevention of influenza during mismatched seasons in older adults with an MF59-adjuvanted quadrivalent influenza vaccine: a randomised, controlled, multicentre, phase 3 efficacy study. Lancet Infect Dis. 2021 Jul;21(7):1027-1037. doi: 10.1016/S1473-3099(20)30694-0. Epub 2021 Feb 9.