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[Study of reactogenicity, safety and immunogenicity of inactivated virosomal split influenza vaccine "Grifor" during phase I clinical trial].

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.

Authors

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Pub Type(s)

Clinical Trial, Phase I
English Abstract
Journal Article

Language

rus

PubMed ID

19338233

Citation

Zverev, V V., et al. "[Study of Reactogenicity, Safety and Immunogenicity of Inactivated Virosomal Split Influenza Vaccine "Grifor" During Phase I Clinical Trial]." Zhurnal Mikrobiologii, Epidemiologii, I Immunobiologii, 2009, pp. 26-31.
Zverev VV, Korovkin SA, Mironov AN, et al. [Study of reactogenicity, safety and immunogenicity of inactivated virosomal split influenza vaccine "Grifor" during phase I clinical trial]. Zh Mikrobiol Epidemiol Immunobiol. 2009.
Zverev, V. V., Korovkin, S. A., Mironov, A. N., Mel'nikov, S. I. a., Mikhaĭlova, N. A., Kostinov, M. P., Dyldina, N. V., & Zhirova, S. N. (2009). [Study of reactogenicity, safety and immunogenicity of inactivated virosomal split influenza vaccine "Grifor" during phase I clinical trial]. Zhurnal Mikrobiologii, Epidemiologii, I Immunobiologii, (1), 26-31.
Zverev VV, et al. [Study of Reactogenicity, Safety and Immunogenicity of Inactivated Virosomal Split Influenza Vaccine "Grifor" During Phase I Clinical Trial]. Zh Mikrobiol Epidemiol Immunobiol. 2009;(1)26-31. PubMed PMID: 19338233.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - [Study of reactogenicity, safety and immunogenicity of inactivated virosomal split influenza vaccine "Grifor" during phase I clinical trial]. AU - Zverev,V V, AU - Korovkin,S A, AU - Mironov,A N, AU - Mel'nikov,S Ia, AU - Mikhaĭlova,N A, AU - Kostinov,M P, AU - Dyldina,N V, AU - Zhirova,S N, PY - 2009/4/3/entrez PY - 2009/4/3/pubmed PY - 2009/5/19/medline SP - 26 EP - 31 JF - Zhurnal mikrobiologii, epidemiologii, i immunobiologii JO - Zh. Mikrobiol. Epidemiol. Immunobiol. IS - 1 N2 - 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. SN - 0372-9311 UR - https://www.unboundmedicine.com/medline/citation/19338233/[Study_of_reactogenicity_safety_and_immunogenicity_of_inactivated_virosomal_split_influenza_vaccine_"Grifor"_during_phase_I_clinical_trial]_ L2 - https://medlineplus.gov/flu.html DB - PRIME DP - Unbound Medicine ER -