STUDY OF REACTOGENICITY, SAFETY AND IMMUNOGENICITY OF INACTIVATED VIROSOMAL SPLIT INFLUENZA VACCINE «GRIFOR®» DURING PHASE I CLINICAL TRIAL


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Abstract

Phase I clinical trial of inactivated virosomal split influenza vaccine «Grifor®» was conducted in the Mechnikov Research Institute of Vaccines and Sera as accredited base for such trials. Forty healthy volunteers (males and females) aged 18—50 years consented to participate in the trial. Reactogenicity, safety, and immunogenicity of new Russian influenza vaccine were assessed. Analysis of obtained results showed that there was evidence of safety and low reactogenicity of the vaccine as well as of its high immunogenic characteristics, which satisfied both the EMEA’s Committee for Proprietal Medicinal Products criteria and requirements of Federal Service for Surveillance for Protection of Consumers Rights and Human Welfare (MU 3.3.2.1758-03) for inactivated influenza vaccines.

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ОЦЕНКА РЕАКТОГЕННОСТИ, БЕЗОПАСНОСТИ И ИММУНОГЕННОСТИ ВИРОСОМАЛЬНОЙ РАСЩЕПЛЕННОЙ ИНАКТИВИРОВАННОЙ ГРИППОЗНОЙ ВАКЦИНЫ «ГРИФОР®» В I ФАЗЕ КЛИНИЧЕСКОГО ИССЛЕДОВАНИЯ
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About the authors

V. V Zverev

Scientific-Manufacturing Association «Microgen»; Mechnikov Research Institute of Vaccines and Sera, Moscow, Russia

S. A Korovkin

Scientific-Manufacturing Association «Microgen»; Mechnikov Research Institute of Vaccines and Sera, Moscow, Russia

A. N Mironov

Scientific-Manufacturing Association «Microgen»; Mechnikov Research Institute of Vaccines and Sera, Moscow, Russia

S. Ya Melnikov

Scientific-Manufacturing Association «Microgen»; Mechnikov Research Institute of Vaccines and Sera, Moscow, Russia

N. A Mikhaylova

Scientific-Manufacturing Association «Microgen»; Mechnikov Research Institute of Vaccines and Sera, Moscow, Russia

M. P Kostinov

Scientific-Manufacturing Association «Microgen»; Mechnikov Research Institute of Vaccines and Sera, Moscow, Russia

N. V Dyldina

Scientific-Manufacturing Association «Microgen»; Mechnikov Research Institute of Vaccines and Sera, Moscow, Russia

S. N Zhirova

Scientific-Manufacturing Association «Microgen»; Mechnikov Research Institute of Vaccines and Sera, Moscow, Russia

References

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Copyright (c) 2009 Zverev V.V., Korovkin S.A., Mironov A.N., Melnikov S.Y., Mikhaylova N.A., Kostinov M.P., Dyldina N.V., Zhirova S.N.

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