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
- Conditions
- Influenza
- Interventions
- Biological: Non-Influenza Comparator (Boostrix)Biological: MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV)
- Registration Number
- NCT02587221
- Lead Sponsor
- Seqirus
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6790
- Males and females ≥ 65 years old who are healthy or have co-morbidities
- 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.
- Ability to attend all scheduled visits and to comply with study procedures
- Hypersensitivity, including allergy to any component of vaccines foreseen in this study
- Abnormal function of the immune system.
- 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.
- Additional eligibility criteria may be discussed by contacting the site
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Non-influenza Comparator Vaccine Non-Influenza Comparator (Boostrix) Non-influenza comparator vaccine aQIV MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) MF59-adjuvanted Quadrivalent Influenza Vaccine (aQIV)
- Primary Outcome Measures
Name Time Method 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. Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer The primary efficacy endpoint was the time of first-occurrence of RT-PCR-confirmed influenza due to any strain of influenza regardless of antigenic match to the strains selected for the seasonal vaccine from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using protocol defined ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the primary endpoint.
Safety Endpoint: The Percentage of Subjects in the Solicited Safety Subset With Solicited Local and Systemic Adverse Events (AE) Day 1 through Day 7 Safety of vaccination was assessed in terms of percentage of subjects reporting solicited local and systemic AEs up to 7 days after vaccination.
Safety Endpoint: Percentage of Subjects With Medically-attended Adverse Events (MAAEs) Within 30 days after of first occurrence RT-PCR confirmed Influenza Safety of vaccination was assessed in terms of percentage of subjects reporting medically attended AEs within 30 days after of first occurrence RT-PCR confirmed influenza.
Safety Endpoint: Percentages of Subjects With Any Unsolicited AE Day 1 through Day 366 Safety of vaccination was assessed in terms of percentage of subjects reporting unsolicited AEs up to 21 days after vaccination.
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) Day 1 to Day 366 Safety of vaccination was assessed in terms of percentage of subjects reporting SAEs, AEs leading to withdrawal, NOCDs, and AESIs up to 366 days after vaccination.
- Secondary Outcome Measures
Name Time Method 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. Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer The secondary efficacy endpoint was the time of first-occurrence of culture confirmed influenza due to any strain of influenza antigenically unmatched to the strains selected for the seasonal vaccine from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using modified CDC ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the secondary endpoint.
Immunogenicity Endpoint: Geometric Mean Hemagglutination Inhibition (HI) Titers (GMT) Days 1 and 22 The log-transformed antibody titers (GMT) at Day 1 and Day 22 were evaluated using an analysis of covariance (ANCOVA) model including factors for site/country, pre-vaccination titer, age, and comorbidity.
Immunogenicity Endpoint: Percentages of Subjects With an HI Titer ≥1:40 Day 22 The percentage of subjects vaccinated with aQIV with a HI antibody titers ≥1:40 was assessed for each of the 4 strains Assessment criteria was considered fulfilled if the lower bound of the two-sided 95% CI for percent of subjects with HI antibody titer ≥1:40 met or exceeded 60% at Day 22.
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. Day 7 to Day 180 after vaccination or end of influenza season, whichever is longer The secondary efficacy endpoint was the time of first-occurrence of culture confirmed influenza due to any strain of influenza regardless of antigenic match from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using modified CDC ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the secondary endpoint.
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. Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer The secondary efficacy endpoint was the time of first-occurrence of culture confirmed influenza due to any strain of influenza antigenically unmatched to the strains selected for the seasonal vaccine from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using protocol defined ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the secondary endpoint.
Immunogenicity Endpoint: Percentages of Subjects Who Achieved Seroconversion (SCR) Day 22 The percentage of subjects achieving SCR at Day 22 was assessed for each of the 4 strains. SCR is defined as HI titer ≥1:40 for subjects seronegative at baseline (HI titer \<1:10) or a minimum 4-fold increase in HI titer for subjects seropositive at baseline (HI titer ≥1:10) on Day 22. Assessment criteria was considered fulfilled if the lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody SCR met or exceeded 30% at Day 22.
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. Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer The secondary efficacy endpoint was the time of first-occurrence of RT-PCR-confirmed influenza due to any strain of influenza regardless of antigenic match to the strains selected for the seasonal vaccine from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using modified CDC ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the secondary efficacy endpoint.
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. Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer The secondary efficacy endpoint was the time of first-occurrence of culture confirmed influenza due to any strain of influenza antigenically matched to the strains selected for the seasonal vaccine from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using protocol defined ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the secondary endpoint.
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. Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer The secondary efficacy endpoint was the time of first-occurrence of culture confirmed influenza due to any strain of influenza antigenically matched to the strains selected for the seasonal vaccine from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using modified CDC ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the secondary endpoint.
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. Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer The secondary efficacy endpoint was the time of first-occurrence of culture confirmed influenza due to any strain of influenza regardless of antigenic match from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using protocol defined ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the secondary endpoint.
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post-vaccination HI Titer Over the Pre-vaccination HI Titer Day 22/Day 1 The GMR was assessed as the postvaccination HI titer divided by the prevaccination HI titer (Day 22/Day 1).
Trial Locations
- Locations (88)
Mhat Silistra
🇧🇬Silistra, Bulgaria
Mc Avicena Sofia
🇧🇬Sofia, Bulgaria
Medical center Synexus Sofia EOOD
🇧🇬Sofia, Bulgaria
Medical Centre Orpheus OOD (Synexus)
🇧🇬Stara Zagora, Bulgaria
Hospital General de Medellín-Luz Castro de Gutiérrez - E.S.E
🇨🇴Medellín, Antioquia, Colombia
Fundacion Cardiomet CEQUIN - Internal Medicine
🇨🇴Armenia, Colombia
Clinica de la Costa
🇨🇴Barranquilla, Colombia
Centro de Atención e Investigación Médica S.A.S. - CAIMED S.A.S.
🇨🇴Bogotá, Colombia
Asociacion IPS Medicos Internistas de Caldas
🇨🇴Manizales, Colombia
CCBR Czech Brno, s.r.o.
🇨🇿Brno, Czechia
FN Hradec Kralove
🇨🇿Hradec Kralove, Czechia
Centrum ockovani a cestovni mediciny
🇨🇿Hradec Králové, Czechia
CCBR Ostrava, s.r.o.
🇨🇿Ostrava, Czechia
Center for Clinical and Basic Research
🇪🇪Tallinn, Harjumaa, Estonia
CCBR Czech, a.s.
🇨🇿Pardubice, Czechia
Clinical Research Center
🇪🇪Tartu, Tartumaa, Estonia
Merelahe Family Doctors Centre
🇪🇪Tallinn, Harjumaa, Estonia
Practice Dr Liga Kozlovska
🇱🇻Balvi, Latvia
Family Doctors Pullerits & Gavronski
🇪🇪Tartu, Tartumaa, Estonia
Practice Dr Ruta Eglite
🇱🇻Kuldiga, Latvia
Family Doctor Andra Lasmane clinic "ALMA"
🇱🇻Riga, Latvia
Practice Dr Inese Petrova
🇱🇻Tukums, Latvia
Klaipeda University Hospital
🇱🇹Klaipeda, Lithuania
JSC Saules seimos medicinos centras
🇱🇹Kaunas, Lithuania
Lietuvos Sveikatos Mokslų Universitetas
🇱🇹Kaunas, Lithuania
UAB InMedica
🇱🇹Kaunas, Lithuania
CCBR
🇱🇹Vilnius, Lithuania
Hospital Sultanah Bahiyah
🇲🇾Alor Setar, Malaysia
Hospital Selayang
🇲🇾Batu Caves, Malaysia
Klinik Kesihatan Greentown
🇲🇾Ipoh, Malaysia
University Malaya Medical Centre (UMMC)
🇲🇾Kuala Lumpur, Malaysia
Hospital Raja Perempuan Zainab II
🇲🇾Kota Bharu, Malaysia
Hospital Seri Manjung
🇲🇾Seri Manjung, Malaysia
Hospital Sibu
🇲🇾Sibu, Malaysia
Klinik Kesihatan Seremban 2
🇲🇾Seremban, Malaysia
De La Salle Health Sciences Institute
🇵🇭Dasmariñas, Cavite, Philippines
West Visayas State University - Medical Center
🇵🇭Jaro, Iloilo, Philippines
Quirino Memorial Medical Center
🇵🇭Quezon, National Capital Region, Philippines
Marilao St. Michael Family Hospital
🇵🇭Bulacan, Philippines
San Juan De Dios Hospital
🇵🇭Pasay, Philippines
Philippine General Hospital
🇵🇭Manila, Philippines
Niepubliczny Zaklad Opieki Zdrowotnej VITAMED
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Synexus Polska Sp. z o.o.
🇵🇱Gdansk, Pomorskie, Poland
Centrum Medyczne Pratia Warszawa
🇵🇱Warszawa, Mazowieckie, Poland
NZOZ Centrum Medyczne "OMEGA" sp. z o.o.
🇵🇱Plock, Mazowieckie, Poland
Specjalistyczny Osrodek Medycyny Wieku Dojrzalego
🇵🇱Warszawa, Mazowieckie, Poland
Centrum Medyczne Pratia Gdynia
🇵🇱Gdynia, Pomorskie, Poland
Centrum Medyczne Pratia Katowice
🇵🇱Katowice, Slaskie, Poland
Praktyka Lekarzy Rodzinnych SALUS
🇵🇱Katowice, Slaskie, Poland
Synexus Polska Sp. z o.o
🇵🇱Poznan, Wielkopolskie, Poland
Centrum Medyczne PRATIA Bydgoszcz
🇵🇱Bydgoszcz, Poland
Specjalistyczny Osrodek Medycyny Wieku Dojrzalego sp. z o.o.
🇵🇱Lodz, Poland
RCMed Oddzial Sochaczew
🇵🇱Sochaczew, Poland
Cabinet Medical Individual Craciun-Nicodin Maria Marcela
🇷🇴Bucuresti, Romania
Centrul Medical Sana
🇷🇴Bucuresti, Romania
Spitalul Clinic C.F. Cluj-Napoca
🇷🇴Cluj, Romania
Clintrial Medical Center
🇷🇴Resca, Romania
Mahidol University (MU) - Faculty of Tropical Medicine
🇹🇭Bangkok, Thailand
Khon Kaen University - Srinagarind Hospital - Medicine
🇹🇭Khon Kaen, Thailand
Ramathibodi Hospital
🇹🇭Bangkok, Thailand
Istanbul University Cerrahpasa Medical Faculty
🇹🇷Cerrahpaşa, Turkey
Ankara Training and Research Hospital
🇹🇷Ankara, Turkey
Bamrasnaradura Infectious Diseases Institute (BIDI)
🇹🇭Mueang Nonthaburi, Thailand
Hacettepe University Medical Faculty
🇹🇷Ankara, Turkey
Ege University Medical Faculty
🇹🇷Izmir, Turkey
Kocaeli University Research and Application Hospital
🇹🇷Kocaeli, Turkey
Ataturk University Medical Faculty
🇹🇷Erzurum, Turkey
Sakarya Training and Research Hospital
🇹🇷Sakarya, Turkey
Medical Trials Institute
🇵🇱Torun, Poland
Cabinet dr. Dana OLAR
🇷🇴Arad, Romania
Mc Smolyan
🇧🇬Smolyan, Bulgaria
Akdeniz University Medical Faculty
🇹🇷Antalya, Turkey
Fundatia Cardioprevent
🇷🇴Timisoara, Romania
Clinica Medicala Synexus
🇷🇴Bucuresti, Romania
Medical Center Excelsior
🇧🇬Sofia, Bulgaria
Medplus Medicina Prepagada
🇨🇴Bogotá, Colombia
MHAT Sv Nikolay Chudotvoretz Lom
🇧🇬Lom, Bulgaria
MBAL TRIMONCIUM (Synexus)
🇧🇬Plovdiv, Bulgaria
Caja de Compesanción Familiar CAFAM
🇨🇴Bogotá, Cundinamarca, Colombia
Kauno klinikine ligonine
🇱🇹Kaunas, Lithuania
RCMed Oddział Nowy Duninow
🇵🇱Nowy Duninow, Poland
MHAT St. Ekaterina
🇧🇬Dimitrovgrad, Bulgaria
SHATPPD-Ruse
🇧🇬Ruse, Bulgaria
SHATPPD-Sofia, City
🇧🇬Sofia, Bulgaria
Medicum AS
🇪🇪Tallinn, Harjumaa, Estonia
Vee Family Doctors Centre
🇪🇪Paide, Järvamaa, Estonia
Republican Siauliai Hospital
🇱🇹Siauliai, Lithuania
Centrul Medical de Diagnostic si Tratament Ambulator NEOMED
🇷🇴Brasov, Romania