title: Safety, immunogenicity and cross-reactivity of a Northern hemisphere 2013-2014 seasonal trivalent inactivated split influenza virus vaccine, Anflu®.
abstract: Anflu® is a seasonal trivalent inactivated split-virion influenza vaccine manufactured by Sinovac Biotech Co., Ltd. The objectives of this study were to evaluate the safety of Anflu® (2013-14 formulation: H1N1, H3N2 and BYAM) in infants and adults and its immunogenicity and cross-reactivity against mismatched influenza B lineage and avian influenza A(H7N9) viruses (hereafter BVIC and H7N9, respectively) in adults. In this phase IV open label trial, infants 6-35 months old (n=61) each received two injections with 28 days apart; adults 18-60 yrs old (n=60) and elderly >60 yrs old (n=61) each received one injection. Information of adverse events was collected through safety observation and follow-up visits. Pre- and post-immune blood samples (day 0 and 21) were collected from subjects ≥18 yrs old to detect hemagglutination inhibition antibody titers and calculate seroprotection rates (SPRs) and seroconversion rates (SCRs). The overall adverse reaction incidence was 1.6% (3/182), and no serious adverse event was reported during the study period. For subjects ≥18 yrs old, the SCRs, SPRs, and the geometric mean titers (GMTs) met the European criteria for all three strains. In addition, the point estimations of SCR, SPR and GMT for BVIC also met the European criteria. Six subjects were seroconverted against H7N9; however the serological results did not meet the European criteria. In conclusion, the results showed a satisfactory safety and immunogenicity profile of Anflu® and cross-reactivity against BVIC, but did not demonstrate cross-reactivity against H7N9 (Clinicaltrials.gov ID: NCT02269852).
authors.affiliation: a Anhui Provincial Center for Disease Control and Prevention , Hefei , China.
authors.forename: Yonggang
authors.initials: Y
authors.lastname: Shen
authors.affiliation: b Sinovac Biotech Co., Ltd Beijing , China.
authors.forename: Yuansheng
authors.initials: Y
authors.lastname: Hu
authors.affiliation: a Anhui Provincial Center for Disease Control and Prevention , Hefei , China.
authors.forename: Fanya
authors.initials: F
authors.lastname: Meng
authors.affiliation: c Guxian County Center for Disease Control and Prevention , Bengbu , China.
authors.forename: Wenjun
authors.initials: W
authors.lastname: Du
authors.affiliation: c Guxian County Center for Disease Control and Prevention , Bengbu , China.
authors.forename: Wei
authors.initials: W
authors.lastname: Li
authors.affiliation: b Sinovac Biotech Co., Ltd Beijing , China.
authors.forename: Yufei
authors.initials: Y
authors.lastname: Song
authors.affiliation: b Sinovac Biotech Co., Ltd Beijing , China.
authors.forename: Xiaoci
authors.initials: X
authors.lastname: Ji
authors.affiliation: b Sinovac Biotech Co., Ltd Beijing , China.
authors.forename: Liqun
authors.initials: L
authors.lastname: Huo
authors.affiliation: b Sinovac Biotech Co., Ltd Beijing , China.
authors.forename: Zhenping
authors.initials: Z
authors.lastname: Fu
authors.affiliation: b Sinovac Biotech Co., Ltd Beijing , China.
authors.forename: Weidong
authors.initials: W
authors.lastname: Yin
mesh_terms: D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D002675:Child, Preschool; D003429:Cross Reactions; D005260:Female; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D000071497:Immunogenicity, Vaccine; D015994:Incidence; D007223:Infant; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D053122:Influenza A Virus, H3N2 Subtype / Q000276:immunology*; D064766:Influenza A Virus, H7N9 Subtype / Q000276:immunology; D009981:Influenza B virus / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D007251:Influenza, Human / Q000276:immunology / Q000517:prevention & control* / Q000821:virology; D008297:Male; D008875:Middle Aged; D012621:Seasons; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000276:immunology; D055815:Young Adult
chemical_list: D000914:Antibodies, Viral; D007252:Influenza Vaccines; D015164:Vaccines, Inactivated
keywords: Anflu®; H7N9; cross-reactivity; immunogenicity; safety; seasonal influenza vaccine