title: Phase IV: randomized controlled trial to evaluate lot consistency of trivalent split influenza vaccines in healthy adults.
abstract: Influenza vaccines are the primary method for preventing influenza and its complications. Considering the increasing demand for influenza vaccines, vaccine manufacturers are required to establish large-scale production systems. This phase IV randomized trial was conducted to evaluate the lot consistency of trivalent split influenza vaccines regarding immunogenicity and safety. A total of 1,023 healthy adults aged 18-64 y were enrolled in the study. Subjects were randomly assigned in a 1:1 ratio to receive the GC FLU® Prefilled Syringe or the GC FLU® Injection, and they were further randomized to one of 3 lots of each vaccine in a 1:1:1 ratio. In both GC FLU® Injection and GC FLU® Prefilled Syringe groups, immune responses were equivalent between lots for each of the 3 vaccine strains on day 21. The 2-sided 95% CI of GMT ratios between pairs of lots were between 0.67 and 1.5, meeting the equivalence criteria. After vaccination, all 3 criteria of the European Medicines Agency were met in both GC FLU® Injection and GC FLU® Prefilled Syringe groups. The vaccines showed tolerable safety profiles without serious adverse events. The demonstration of lot consistency, robust immunogenic responses and favorable safety profiles support the reliability of mass-manufacturing systems for the GC FLU® Injection and GC FLU® Prefilled Syringe.
authors.affiliation: a Division of Infectious Diseases; Department of Internal Medicine ; Korea University College of Medicine ; Seoul , Korea.
authors.forename: Joon Young
authors.initials: JY
authors.lastname: Song
authors.forename: Hee Jin
authors.initials: HJ
authors.lastname: Cheong
authors.forename: Jacob
authors.initials: J
authors.lastname: Lee
authors.forename: Seong-Heon
authors.initials: SH
authors.lastname: Wie
authors.forename: Kyung-Hwa
authors.initials: KH
authors.lastname: Park
authors.forename: Sae Yoon
authors.initials: SY
authors.lastname: Kee
authors.forename: Hye Won
authors.initials: HW
authors.lastname: Jeong
authors.forename: Yeon-Sook
authors.initials: YS
authors.lastname: Kim
authors.forename: Ji Yun
authors.initials: JY
authors.lastname: Noh
authors.forename: Won Suk
authors.initials: WS
authors.lastname: Choi
authors.forename: Dae Won
authors.initials: DW
authors.lastname: Park
authors.forename: Jang Wook
authors.initials: JW
authors.lastname: Sohn
authors.forename: Woo Joo
authors.initials: WJ
authors.lastname: Kim
mesh_terms: D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood* / Q000276:immunology; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D064368:Healthy Volunteers; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology; D053122:Influenza A Virus, H3N2 Subtype / Q000276:immunology; D009981:Influenza B virus / Q000276:immunology; D007252:Influenza Vaccines / Q000009:adverse effects / Q000276:immunology* / Q000627:therapeutic use; D007251:Influenza, Human / Q000276:immunology / Q000517:prevention & control* / Q000821:virology; D008297:Male; D008875:Middle Aged; D011786:Quality Control; D015203:Reproducibility of Results; D014611:Vaccination; D064166:Vaccine Potency; D015164:Vaccines, Inactivated / Q000276:immunology; D055815:Young Adult
chemical_list: D000914:Antibodies, Viral; D007252:Influenza Vaccines; D015164:Vaccines, Inactivated
keywords: EMA, European Medicines Agency; GMT, geometric mean titer; GMTR, geometric mean titer ratio; QIV, quadrivalent influenza vaccine; TIV, trivalent influenza vaccine; immunogenicity; influenza vaccines; lot consistency; safety