CLINICAL TRIAL OF NEW INACTIVATED INFLUENZA VACCINE «GRIFOR®»


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Abstract

Aim. To confirm and prove on the extended contingent of volunteers the non-reactogenicity, safety and immunogenicity of «Grifor®» vaccine in comparative trial with registered in Russia commercial vaccine «Vaxigrip». Materials and methods. Phase II clinical trial was performed on the research bases of Mechnikov Institute of Vaccines and Sera and Institute of Influenza. In single-blind comparative prospective randomized trial 300 adult volunteers (150 volunteers on each base) aged 18 — 60 y.o. were divided on 3 equivalent groups. Assessment of antigenic characteristics of «Grifor®» vaccine was performed using hemagglutination inhibition assay (HAI) with chicken erythrocytes measuring geometric mean titer (GMT), seroconversion factor as well as level of seroconversion and seroprotection. Results. Previously performed studies proved non-reactogenicity, safety and high immunogenicity of «Grifor®», whereas this comparative trial performed with commercial vaccine «Vaxigrip» did not reveal significant advantage in any of studied vaccine. Conclusion. «Grifor®» vaccine meet the requirements of both EMEA CPMP and methodic guidelines МУ 3.3.2.1758-03 for inactivated influenza vaccines, which allows to register vaccine «Grifor®» in Russian Federation.

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КЛИНИЧЕСКОЕ ИССЛЕДОВАНИЕ НОВОЙ ИНАКТИВИРОВАННОЙ ГРИППОЗНОЙ ВАКЦИНЫ «ГРИФОР®»
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About the authors

V. V Zverev

Mechnikov Research Institute of Vaccines and Sera, Moscow; Research Institute of Influenza, SaintPetersburg; Fort Ltd., Ryazan, Russia

O. I Kiselev

Mechnikov Research Institute of Vaccines and Sera, Moscow; Research Institute of Influenza, SaintPetersburg; Fort Ltd., Ryazan, Russia

S. A Korovkin

Mechnikov Research Institute of Vaccines and Sera, Moscow; Research Institute of Influenza, SaintPetersburg; Fort Ltd., Ryazan, Russia

A. N Mironov

Mechnikov Research Institute of Vaccines and Sera, Moscow; Research Institute of Influenza, SaintPetersburg; Fort Ltd., Ryazan, Russia

S. Ya Melnikov

Mechnikov Research Institute of Vaccines and Sera, Moscow; Research Institute of Influenza, SaintPetersburg; Fort Ltd., Ryazan, Russia

N. A Mikhaylova

Mechnikov Research Institute of Vaccines and Sera, Moscow; Research Institute of Influenza, SaintPetersburg; Fort Ltd., Ryazan, Russia

M. P Kostinov

Mechnikov Research Institute of Vaccines and Sera, Moscow; Research Institute of Influenza, SaintPetersburg; Fort Ltd., Ryazan, Russia

M. K Erofeeva

Mechnikov Research Institute of Vaccines and Sera, Moscow; Research Institute of Influenza, SaintPetersburg; Fort Ltd., Ryazan, Russia

A. A Sominina

Mechnikov Research Institute of Vaccines and Sera, Moscow; Research Institute of Influenza, SaintPetersburg; Fort Ltd., Ryazan, Russia

N. V Dyldina

Mechnikov Research Institute of Vaccines and Sera, Moscow; Research Institute of Influenza, SaintPetersburg; Fort Ltd., Ryazan, Russia

S. N Zhirova

Mechnikov Research Institute of Vaccines and Sera, Moscow; Research Institute of Influenza, SaintPetersburg; Fort Ltd., Ryazan, Russia

M. A Stukova

Mechnikov Research Institute of Vaccines and Sera, Moscow; Research Institute of Influenza, SaintPetersburg; Fort Ltd., Ryazan, Russia

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Copyright (c) 2009 Zverev V.V., Kiselev O.I., Korovkin S.A., Mironov A.N., Melnikov S.Y., Mikhaylova N.A., Kostinov M.P., Erofeeva M.K., Sominina A.A., Dyldina N.V., Zhirova S.N., Stukova M.A.

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