Phase IV: Randomized controlled trial to evaluate lot consistency of trivalent split influenza vaccines in healthy adults

Joon-Young Song, Hee-Jin Cheong, Jacob Lee, Seong Heon Wie, Kyung Hwa Park, Sae Yoon Kee, Hye Won Jeong, Yeon Sook Kim, Ji Yun Noh, Wonseok Choi, Dae Won Park, Jang Wook Sohn, Woo Joo Kim

Research output: Contribution to journalArticle

1 Citation (Scopus)

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.

Original languageEnglish
Pages (from-to)2958-2964
Number of pages7
JournalHuman Vaccines and Immunotherapeutics
Volume10
Issue number10
DOIs
Publication statusPublished - 2014 Oct 1

Keywords

  • Immunogenicity
  • Influenza vaccines
  • Lot consistency
  • Safety

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Pharmacology

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