Influenza

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

NCT02587221 | PHASE 3 | INTERVENTIONAL

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.

89 Sites

6790 Participants

COMPLETED

65 Years

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SUBMIT

MHAT St. Ekaterina

Dimitrovgrad,Bulgaria

MHAT Sv Nikolay Chudotvoretz Lom

Lom,Bulgaria

MBAL TRIMONCIUM (Synexus)

Plovdiv,Bulgaria

SHATPPDRuse

Rousse,Bulgaria,7000

Mhat Silistra

Silistra,Bulgaria,7000

Mc Smolyan

Smolyan,Bulgaria,7000

Mc Avicena Sofia

Sofia,Bulgaria,7000

Medical Center Excelsior

Sofia,Bulgaria,7000

Medical center Synexus Sofia EOOD

Sofia,Bulgaria,7000

SHATPPDSofia, City

Sofia,Bulgaria,7000

Medical Centre Orpheus OOD (Synexus)

Stara Zagora,Bulgaria,7000

Hospital General de MedellnLuz Castro de Gutirrez E.S.E

Medellín,Antioquia,Colombia,0500515

Caja de Compesancin Familiar CAFAM

Bogotá,Cundinamarca,Colombia,74136-3367

Fundacion Cardiomet CEQUIN Internal Medicine

Armenia,Cundinamarca,Colombia,NAP

Clinica de la Costa

Barranquilla,Cundinamarca,Colombia,NAP

Centro de Atencin e Investigacin Mdica S.A.S. CAIMED S.A.S.

Bogotá,Cundinamarca,Colombia,NAP

Medplus Medicina Prepagada

Bogotá,Cundinamarca,Colombia,NAP

Asociacion IPS Medicos Internistas de Caldas

Manizales,Cundinamarca,Colombia,170004

CCBR Czech Brno, s.r.o.

Brno,Cundinamarca,Czechia,170004

Centrum ockovani a cestovni mediciny

Hradec Králové,Cundinamarca,Czechia,170004

FN Hradec Kralove

Hradec Králové,Cundinamarca,Czechia,170004

CCBR Ostrava, s.r.o.

Ostrava,Cundinamarca,Czechia,170004

CCBR Czech, a.s.

Pardubice,Cundinamarca,Czechia,170004

Center for Clinical and Basic Research

Tallinn,Harju,Estonia,170004

Medicum AS

Tallinn,Harju,Estonia,170004

Merelahe Family Doctors Centre

Tallinn,Harju,Estonia,170004

Vee Family Doctors Centre

Paide,Järvamaa,Estonia,170004

Clinical Research Center

Tartu,Tartu,Estonia,170004

Family Doctors Pullerits & Gavronski

Tartu,Tartu,Estonia,170004

Practice Dr Liga Kozlovska

Balvi,Tartu,Latvia,170004

Practice Dr Ruta Eglite

Kuldīga,Tartu,Latvia,170004

Family Doctor Andra Lasmane clinic "ALMA"

Riga,Tartu,Latvia,170004

Practice Dr Inese Petrova

Tukums,Tartu,Latvia,170004

JSC Saules seimos medicinos centras

Kaunas,Tartu,Lithuania,170004

Kauno klinikine ligonine

Kaunas,Tartu,Lithuania,170004

Lietuvos Sveikatos Moksl Universitetas

Kaunas,Tartu,Lithuania,170004

UAB InMedica

Kaunas,Tartu,Lithuania,170004

Klaipeda University Hospital

Klaipėda,Tartu,Lithuania,170004

Republican Siauliai Hospital

Šiauliai,Tartu,Lithuania,170004

CCBR

Vilnius,Tartu,Lithuania,170004

Hospital Sultanah Bahiyah

Alor Star,Tartu,Malaysia,170004

Hospital Selayang

Batu Caves,Tartu,Malaysia,170004

Klinik Kesihatan Greentown

Ipoh,Tartu,Malaysia,170004

Hospital Raja Perempuan Zainab II

Kota Bharu,Tartu,Malaysia,170004

University Malaya Medical Centre (UMMC)

Kuala Lumpur,Tartu,Malaysia,170004

Klinik Kesihatan Seremban

Seremban,Tartu,Malaysia,170004

Hospital Seri Manjung

Seri Manjung,Tartu,Malaysia,170004

Hospital Sibu

Sibu,Tartu,Malaysia,170004

De La Salle Health Sciences Institute

Dasmariñas,Cavite,Philippines,4114

West Visayas State University Medical Center

Jaro,Iloilo,Philippines,5000

Quirino Memorial Medical Center

Quezon City,National Capital Region,Philippines,1109

Marilao St. Michael Family Hospital

Bulacan,National Capital Region,Philippines,3019

Philippine General Hospital

Manila,National Capital Region,Philippines,1000

San Juan De Dios Hospital

Pasay,National Capital Region,Philippines,1300

Synexus Polska Sp. z o.o

Poznan,Greater Poland Voivodeship,Poland,1300

Niepubliczny Zaklad Opieki Zdrowotnej VITAMED

Bydgoszcz,Kuyavian-Pomeranian Voivodeship,Poland,1300

Synexus Polska Sp. z o.o.

Wroclaw,Lower Silesian Voivodeship,Poland,1300

NZOZ Centrum Medyczne "OMEGA" sp. z o.o.

Płock,Masovian Voivodeship,Poland,1300

Centrum Medyczne Pratia Warszawa

Warsaw,Masovian Voivodeship,Poland,1300

Specjalistyczny Osrodek Medycyny Wieku Dojrzalego

Warsaw,Masovian Voivodeship,Poland,1300

Synexus Polska Sp. z o.o.

Gdansk,Pomeranian Voivodeship,Poland,80-382

Centrum Medyczne Pratia Gdynia

Gdynia,Pomeranian Voivodeship,Poland,80-382

Centrum Medyczne Pratia Katowice

Katowice,Silesian Voivodeship,Poland,80-382

Praktyka Lekarzy Rodzinnych SALUS

Katowice,Silesian Voivodeship,Poland,80-382

Centrum Medyczne PRATIA Bydgoszcz

Bydgoszcz,Silesian Voivodeship,Poland,80-382

Specjalistyczny Osrodek Medycyny Wieku Dojrzalego sp. z o.o.

Lodz,Silesian Voivodeship,Poland,80-382

RCMed Oddzia Nowy Duninow

Nowy Duninów,Silesian Voivodeship,Poland,80-382

RCMed Oddzial Sochaczew

Sochaczew,Silesian Voivodeship,Poland,80-382

Medical Trials Institute

Torun,Silesian Voivodeship,Poland,80-382

Cabinet dr. Dana OLAR

Arad,Silesian Voivodeship,Romania,80-382

Centrul Medical de Diagnostic si Tratament Ambulator NEOMED

Brasov,Silesian Voivodeship,Romania,80-382

Cabinet Medical Individual CraciunNicodin Maria Marcela

Bucharest,Silesian Voivodeship,Romania,80-382

Centrul Medical Sana

Bucharest,Silesian Voivodeship,Romania,80-382

Clinica Medicala Synexus

Bucharest,Silesian Voivodeship,Romania,80-382

Spitalul Clinic C.F. ClujNapoca

Cluj-Napoca,Silesian Voivodeship,Romania,80-382

Clintrial Medical Center

Reșca,Silesian Voivodeship,Romania,80-382

Fundatia Cardioprevent

Timișoara,Silesian Voivodeship,Romania,80-382

Ramathibodi Hospital

Bangkok,Silesian Voivodeship,Thailand,10400

Mahidol University (MU) Faculty of Tropical Medicine

Bangkok,Silesian Voivodeship,Thailand,10400

Khon Kaen University Srinagarind Hospital Medicine

Khon Kaen,Silesian Voivodeship,Thailand,40002

Bamrasnaradura Infectious Diseases Institute (BIDI)

Nonthaburi,Silesian Voivodeship,Thailand,40002

Ankara Training and Research Hospital

Ankara,Silesian Voivodeship,Turkey (Türkiye),40002

Hacettepe University Medical Faculty

Ankara,Silesian Voivodeship,Turkey (Türkiye),40002

Akdeniz University Medical Faculty

Antalya,Silesian Voivodeship,Turkey (Türkiye),40002

Istanbul University Cerrahpasa Medical Faculty

Cerrahpaşa,Silesian Voivodeship,Turkey (Türkiye),40002

Ataturk University Medical Faculty

Erzurum,Silesian Voivodeship,Turkey (Türkiye),40002

Ege University Medical Faculty

Izmir,Silesian Voivodeship,Turkey (Türkiye),40002

Kocaeli University Research and Application Hospital

Kocaeli,Silesian Voivodeship,Turkey (Türkiye),40002

Sakarya Training and Research Hospital

Sakarya,Silesian Voivodeship,Turkey (Türkiye),40002

Study 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

Additional Studies

Additional studies can be found at ClinicalTrials.gov