title: [Clinical trial of new inactivated influenza vaccine "Grifor"].
abstract: OBJECTIVE
  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".
  
  
  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.
  
  
  CONCLUSIONS
  "Grifor" vaccine meet the requirements of both EMEA CPMP and methodic guidelines MY 3.3.2. 1758-03 for inactivated influenza vaccines, which allows to register vaccine "Grifor" in Russian Federation.
authors.forename: V V
authors.initials: VV
authors.lastname: Zverev
authors.forename: O I
authors.initials: OI
authors.lastname: Kiselev
authors.forename: S A
authors.initials: SA
authors.lastname: Korovkin
authors.forename: A N
authors.initials: AN
authors.lastname: Mironov
authors.forename: S Ia
authors.initials: SIa
authors.lastname: Mel'nikov
authors.forename: N A
authors.initials: NA
authors.lastname: Mikhaĭlova
authors.forename: M P
authors.initials: MP
authors.lastname: Kostinov
authors.forename: M K
authors.initials: MK
authors.lastname: Erofeeva
authors.forename: A A
authors.initials: AA
authors.lastname: Solomina
authors.forename: N V
authors.initials: NV
authors.lastname: Dyldina
authors.forename: S N
authors.initials: SN
authors.lastname: Zhirova
authors.forename: M A
authors.initials: MA
authors.lastname: Stukova
mesh_terms: D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D005260:Female; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D007252:Influenza Vaccines / Q000009:adverse effects / Q000276:immunology / Q000592:standards; D007251:Influenza, Human / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D012426:Russia; D014611:Vaccination
chemical_list: D000914:Antibodies, Viral; C540614:Grifor; D007252:Influenza Vaccines