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

PHASE3CompletedINTERVENTIONAL
Enrollment

6,790

Participants

Timeline

Start Date

September 30, 2016

Primary Completion Date

July 23, 2018

Study Completion Date

July 23, 2018

Conditions
Influenza
Interventions
BIOLOGICAL

MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV)

1 dose approximately 0.5 mL of aQIV

BIOLOGICAL

Non-Influenza Comparator (Boostrix)

1 dose approximately 0.5 mL dose of Non-influenza comparator vaccine (Boostrix)

Trial Locations (89)

1000

Philippine General Hospital, Manila

1109

Quirino Memorial Medical Center, Quezon City

1300

San Juan De Dios Hospital, Pasay

3019

Marilao St. Michael Family Hospital, Bulacan

4114

De La Salle Health Sciences Institute, Dasmariñas

5000

West Visayas State University - Medical Center, Jaro

7000

SHATPPD-Ruse, Rousse

10400

Ramathibodi Hospital, Bangkok

40002

Khon Kaen University - Srinagarind Hospital - Medicine, Khon Kaen

170004

Asociacion IPS Medicos Internistas de Caldas, Manizales

Unknown

MHAT St. Ekaterina, Dimitrovgrad

MHAT Sv Nikolay Chudotvoretz Lom, Lom

MBAL TRIMONCIUM (Synexus), Plovdiv

Mhat Silistra, Silistra

Mc Smolyan, Smolyan

Mc Avicena Sofia, Sofia

Medical Center Excelsior, Sofia

Medical center Synexus Sofia EOOD, Sofia

SHATPPD-Sofia, City, Sofia

Medical Centre Orpheus OOD (Synexus), Stara Zagora

CCBR Czech Brno, s.r.o., Brno

Centrum ockovani a cestovni mediciny, Hradec Králové

FN Hradec Kralove, Hradec Králové

CCBR Ostrava, s.r.o., Ostrava

CCBR Czech, a.s., Pardubice

Center for Clinical and Basic Research, Tallinn

Medicum AS, Tallinn

Merelahe Family Doctors Centre, Tallinn

Vee Family Doctors Centre, Paide

Clinical Research Center, Tartu

Family Doctors Pullerits & Gavronski, Tartu

Practice Dr Liga Kozlovska, Balvi

Practice Dr Ruta Eglite, Kuldīga

"Family Doctor Andra Lasmane clinic ALMA", Riga

Practice Dr Inese Petrova, Tukums

JSC Saules seimos medicinos centras, Kaunas

Kauno klinikine ligonine, Kaunas

Lietuvos Sveikatos Mokslų Universitetas, Kaunas

UAB InMedica, Kaunas

Klaipeda University Hospital, Klaipėda

Republican Siauliai Hospital, Šiauliai

CCBR, Vilnius

Hospital Sultanah Bahiyah, Alor Star

Hospital Selayang, Batu Caves

Klinik Kesihatan Greentown, Ipoh

Hospital Raja Perempuan Zainab II, Kota Bharu

University Malaya Medical Centre (UMMC), Kuala Lumpur

Klinik Kesihatan Seremban 2, Seremban

Hospital Seri Manjung, Seri Manjung

Hospital Sibu, Sibu

Synexus Polska Sp. z o.o, Poznan

Niepubliczny Zaklad Opieki Zdrowotnej VITAMED, Bydgoszcz

Synexus Polska Sp. z o.o., Wroclaw

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

Centrum Medyczne Pratia Warszawa, Warsaw

Specjalistyczny Osrodek Medycyny Wieku Dojrzalego, Warsaw

Centrum Medyczne Pratia Gdynia, Gdynia

Centrum Medyczne Pratia Katowice, Katowice

Praktyka Lekarzy Rodzinnych SALUS, Katowice

Centrum Medyczne PRATIA Bydgoszcz, Bydgoszcz

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

RCMed Oddział Nowy Duninow, Nowy Duninów

RCMed Oddzial Sochaczew, Sochaczew

Medical Trials Institute, Torun

Cabinet dr. Dana OLAR, Arad

Centrul Medical de Diagnostic si Tratament Ambulator NEOMED, Brasov

Cabinet Medical Individual Craciun-Nicodin Maria Marcela, Bucharest

Centrul Medical Sana, Bucharest

Clinica Medicala Synexus, Bucharest

Spitalul Clinic C.F. Cluj-Napoca, Cluj-Napoca

Clintrial Medical Center, Reșca

Fundatia Cardioprevent, Timișoara

Mahidol University (MU) - Faculty of Tropical Medicine, Bangkok

Bamrasnaradura Infectious Diseases Institute (BIDI), Nonthaburi

Ankara Training and Research Hospital, Ankara

Hacettepe University Medical Faculty, Ankara

Akdeniz University Medical Faculty, Antalya

Istanbul University Cerrahpasa Medical Faculty, Cerrahpaşa

Ataturk University Medical Faculty, Erzurum

Ege University Medical Faculty, Izmir

Kocaeli University Research and Application Hospital, Kocaeli

Sakarya Training and Research Hospital, Sakarya

0500515

Hospital General de Medellín-Luz Castro de Gutiérrez - E.S.E, Medellín

74136-3367

Caja de Compesanción Familiar CAFAM, Bogotá

NAP

Fundacion Cardiomet CEQUIN - Internal Medicine, Armenia

Clinica de la Costa, Barranquilla

Centro de Atención e Investigación Médica S.A.S. - CAIMED S.A.S., Bogotá

Medplus Medicina Prepagada, Bogotá

80-382

Synexus Polska Sp. z o.o., Gdansk

All Listed Sponsors
lead

Seqirus

INDUSTRY

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 | Biotech Hunter | Biotech Hunter