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
NCT ID: NCT02587221
Last Updated: 2020-06-17
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
6790 participants
INTERVENTIONAL
2016-09-30
2018-07-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
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 Safety and Immunogenicity Study of aQIV in Elderly Adults
NCT03314662
A Clinical Study to Evaluate the Immunogenicity and Safety of an Adjuvanted Quadrivalent Influenza Vaccine Compared With a Licensed Quadrivalent Vaccine in Adults 50 to 64 Years of Age
NCT05044195
Safety and Immunogenicity of Different Formulations of an MF59-Adjuvanted Influenza Vaccine in Older Adults ≥50 Years of Age
NCT05501561
Safety and Immunogenicity of Different Formulations of an MF59-Adjuvanted Influenza Vaccine in Older Adults
NCT04782323
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
aQIV
MF59-adjuvanted Quadrivalent Influenza Vaccine (aQIV)
MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV)
1 dose approximately 0.5 mL of aQIV
Non-influenza Comparator Vaccine
Non-influenza comparator vaccine
Non-Influenza Comparator (Boostrix)
1 dose approximately 0.5 mL dose of Non-influenza comparator vaccine (Boostrix)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV)
1 dose approximately 0.5 mL of aQIV
Non-Influenza Comparator (Boostrix)
1 dose approximately 0.5 mL dose of Non-influenza comparator vaccine (Boostrix)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Seqirus
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Program Manager
Role: STUDY_DIRECTOR
Seqirus
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
MHAT St. Ekaterina
Dimitrovgrad, , Bulgaria
MHAT Sv Nikolay Chudotvoretz Lom
Lom, , Bulgaria
MBAL TRIMONCIUM (Synexus)
Plovdiv, , Bulgaria
SHATPPD-Ruse
Rousse, , Bulgaria
Mhat Silistra
Silistra, , Bulgaria
Mc Smolyan
Smolyan, , Bulgaria
Mc Avicena Sofia
Sofia, , Bulgaria
Medical Center Excelsior
Sofia, , Bulgaria
Medical center Synexus Sofia EOOD
Sofia, , Bulgaria
SHATPPD-Sofia, City
Sofia, , Bulgaria
Medical Centre Orpheus OOD (Synexus)
Stara Zagora, , Bulgaria
Hospital General de Medellín-Luz Castro de Gutiérrez - E.S.E
Medellín, Antioquia, Colombia
Caja de Compesanción Familiar CAFAM
Bogotá, Cundinamarca, 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
Medplus Medicina Prepagada
Bogotá, , Colombia
Asociacion IPS Medicos Internistas de Caldas
Manizales, , Colombia
CCBR Czech Brno, s.r.o.
Brno, , Czechia
Centrum ockovani a cestovni mediciny
Hradec Králové, , Czechia
FN Hradec Kralove
Hradec Králové, , Czechia
CCBR Ostrava, s.r.o.
Ostrava, , Czechia
CCBR Czech, a.s.
Pardubice, , Czechia
Center for Clinical and Basic Research
Tallinn, Harju, Estonia
Medicum AS
Tallinn, Harju, Estonia
Merelahe Family Doctors Centre
Tallinn, Harju, Estonia
Vee Family Doctors Centre
Paide, Järvamaa, Estonia
Clinical Research Center
Tartu, Tartu, Estonia
Family Doctors Pullerits & Gavronski
Tartu, Tartu, Estonia
Practice Dr Liga Kozlovska
Balvi, , Latvia
Practice Dr Ruta Eglite
Kuldīga, , Latvia
Family Doctor Andra Lasmane clinic "ALMA"
Riga, , Latvia
Practice Dr Inese Petrova
Tukums, , Latvia
JSC Saules seimos medicinos centras
Kaunas, , Lithuania
Kauno klinikine ligonine
Kaunas, , Lithuania
Lietuvos Sveikatos Mokslų Universitetas
Kaunas, , Lithuania
UAB InMedica
Kaunas, , Lithuania
Klaipeda University Hospital
Klaipėda, , Lithuania
Republican Siauliai Hospital
Šiauliai, , Lithuania
CCBR
Vilnius, , Lithuania
Hospital Sultanah Bahiyah
Alor Star, , Malaysia
Hospital Selayang
Batu Caves, , Malaysia
Klinik Kesihatan Greentown
Ipoh, , Malaysia
Hospital Raja Perempuan Zainab II
Kota Bharu, , Malaysia
University Malaya Medical Centre (UMMC)
Kuala Lumpur, , Malaysia
Klinik Kesihatan Seremban 2
Seremban, , Malaysia
Hospital Seri Manjung
Seri Manjung, , Malaysia
Hospital Sibu
Sibu, , Malaysia
De La Salle Health Sciences Institute
Dasmariñas, Cavite, Philippines
West Visayas State University - Medical Center
Jaro, Iloilo, Philippines
Quirino Memorial Medical Center
Quezon City, National Capital Region, Philippines
Marilao St. Michael Family Hospital
Bulacan, , Philippines
Philippine General Hospital
Manila, , Philippines
San Juan De Dios Hospital
Pasay, , Philippines
Synexus Polska Sp. z o.o
Poznan, Greater Poland Voivodeship, Poland
Niepubliczny Zaklad Opieki Zdrowotnej VITAMED
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Synexus Polska Sp. z o.o.
Wroclaw, Lower Silesian Voivodeship, Poland
NZOZ Centrum Medyczne "OMEGA" sp. z o.o.
Płock, Masovian Voivodeship, Poland
Centrum Medyczne Pratia Warszawa
Warsaw, Masovian Voivodeship, Poland
Specjalistyczny Osrodek Medycyny Wieku Dojrzalego
Warsaw, Masovian Voivodeship, Poland
Synexus Polska Sp. z o.o.
Gdansk, Pomeranian Voivodeship, Poland
Centrum Medyczne Pratia Gdynia
Gdynia, Pomeranian Voivodeship, Poland
Centrum Medyczne Pratia Katowice
Katowice, Silesian Voivodeship, Poland
Praktyka Lekarzy Rodzinnych SALUS
Katowice, Silesian Voivodeship, Poland
Centrum Medyczne PRATIA Bydgoszcz
Bydgoszcz, , Poland
Specjalistyczny Osrodek Medycyny Wieku Dojrzalego sp. z o.o.
Lodz, , Poland
RCMed Oddział Nowy Duninow
Nowy Duninów, , Poland
RCMed Oddzial Sochaczew
Sochaczew, , Poland
Medical Trials Institute
Torun, , Poland
Cabinet dr. Dana OLAR
Arad, , Romania
Centrul Medical de Diagnostic si Tratament Ambulator NEOMED
Brasov, , Romania
Cabinet Medical Individual Craciun-Nicodin Maria Marcela
Bucharest, , Romania
Centrul Medical Sana
Bucharest, , Romania
Clinica Medicala Synexus
Bucharest, , Romania
Spitalul Clinic C.F. Cluj-Napoca
Cluj-Napoca, , Romania
Clintrial Medical Center
Reșca, , Romania
Fundatia Cardioprevent
Timișoara, , Romania
Ramathibodi Hospital
Bangkok, , Thailand
Mahidol University (MU) - Faculty of Tropical Medicine
Bangkok, , Thailand
Khon Kaen University - Srinagarind Hospital - Medicine
Khon Kaen, , Thailand
Bamrasnaradura Infectious Diseases Institute (BIDI)
Nonthaburi, , Thailand
Ankara Training and Research Hospital
Ankara, , Turkey (Türkiye)
Hacettepe University Medical Faculty
Ankara, , Turkey (Türkiye)
Akdeniz University Medical Faculty
Antalya, , Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty
Cerrahpaşa, , Turkey (Türkiye)
Ataturk University Medical Faculty
Erzurum, , Turkey (Türkiye)
Ege University Medical Faculty
Izmir, , Turkey (Türkiye)
Kocaeli University Research and Application Hospital
Kocaeli, , Turkey (Türkiye)
Sakarya Training and Research Hospital
Sakarya, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015-000728-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
V118_18
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.