Clinical Trial Details

NCT ID: NCT02587221
Date Last Changed: November 28, 2016

Overview

Research Study Summary

Patients are needed to participate in a clinical research study evaluating MF59-adjuvanted Quadrivalent Influenza Vaccine and Non-Influenza Comparator vaccine for the treatment of Influenza

Research Study 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

Purpose

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.

To Learn more

Recruitment Details

Phase
3
Gender
All
Age
65 and up
Overall Status
Recruiting
Lead Sponsor
Seqirus
Duration
22 Months
Facility Type
N/A
Compensation

Eligibility

All ages 65 Years and up

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

Site Locations (26)

Country State City Zip Facility and Contact
Czech Republic Brno CCBR Czech Brno, s.r.o.
Czech Republic Hradec Kravlove Centrum ockovani a cestovni mediciny
Czech Republic Ostrava CCBR Ostrava, s.r.o.
Czech Republic Pardubice CCBR Czech, a.s.
Estonia Harjumaa Tallinn Center for Clinical and Basic Research
Estonia Harjumaa Tallinn Merelahe Family Doctors Centre
Estonia Järvamaa Paide Vee Family Doctors Centre
Estonia Tartumaa Tartu Clinical Research Center
Estonia Tartumaa Tartu Family Doctors Pullerits & Gavronski
Latvia Riga Family Doctor Andra Lasmane clinic "ALMA"
Lithuania Kaunas JSC Saules seimos medicinos centras
Lithuania Kaunas UAB InMedica
Lithuania Klaipeda Klaipeda University Hospital
Lithuania Siauliai Republican Siauliai Hospital
Lithuania Vilnius CCBR
Poland Dolnoslaskie Wroclaw Synexus Polska Sp. z o.o.
Poland Kujawsko-pomorskie Bydgoszcz Niepubliczny Zaklad Opieki Zdrowotnej VITAMED
Poland Mazowieckie Plock NZOZ Centrum Medyczne "OMEGA" sp. z o.o.
Poland Mazowieckie Warszawa Specjalistyczny Osrodek Medycyny Wieku Dojrzalego
Poland Slaskie Katowice Centrum Medyczne Pratia Katowice
Poland Slaskie Katowice Praktyka Lekarzy Rodzinnych SALUS
Poland Wielkopolskie Poznan Synexus Polska Sp. z o.o
Poland Gdansk Synexus Polska Sp. z o.o.
Poland Lodz Specjalistyczny Osrodek Medycyny Wieku Dojrzalego sp. z o.o.
Poland Nowy Duninow RCMed Oddział Nowy Duninow
Poland Sochaczew RCMed Oddzial Sochaczew

Contact

Seqirus Trial Disclosure Lead

E-mail:

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