title: Immunogenicity and safety of a cell culture-derived inactivated trivalent influenza vaccine (NBP607): A randomized, double-blind, multi-center, phase 3 clinical trial.
abstract: BACKGROUND
  Cell culture-derived influenza vaccines (CCIVs) have several important advantages over egg-based influenza vaccines, including shorter production time, better preservation of wild-type virus antigenicity and large-scale production capacity.
  
  
  METHODS
  A randomized, double-blind, phase 3 trial was undertaken to evaluate the immunogenicity and safety of a novel cell culture-derived inactivated, subunit, trivalent influenza vaccine (NBP607, SK Chemicals, Seongnam, Korea) compared to the control vaccine (AgrippalS1, Novartis Vaccines and Diagnostics Srl, Siena, Italy) among healthy adults aged 19 years or older (Clinical trial Number-NCT02344134). Immunogenicity was determined at pre-vaccination, 1 month and 6 month post-vaccination by the hemagglutination inhibition assay. Solicited and unsolicited adverse events were assessed after vaccination.
  
  
  RESULTS
  A total of 1156 healthy subjects were recruited. NBP607 met all of the criteria of Committee for Medicinal Products for Human Use (CHMP) at 21 days post-vaccination. Contrary to NBP607, the control vaccine did not satisfy the seroconversion criteria for influenza B irrespective of age. Although the geometric mean titer for each influenza subtype declined gradually, seroprotection rate still remained ≥80% for all subtypes up to six month after NBP607 administration. NBP607 recipients met the seroprotection criteria for all three influenza subtypes up to 6 month post-vaccination. There was no significant difference in the occurrence of adverse events between the NBP607 and control groups.
  
  
  CONCLUSIONS
  NBP607, a novel CCIV, showed excellent immunogenicity that lasted ≥6 months after vaccination and had tolerable safety profiles. In particular, NBP607 was more immunogenic against influenza B compared to the control, an egg-based subunit vaccine.
authors: Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea; Transgovernmental Enterprise for Pandemic Influenza in Korea, Seoul, Republic of Korea.
authors: Joon Young
authors: JY
authors: Song
authors: Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.
authors: Hee Jin
authors: HJ
authors: Cheong
authors: Hallym University College of Medicine, Seoul, Republic of Korea.
authors: Jacob
authors: J
authors: Lee
authors: Hallym University College of Medicine, Seoul, Republic of Korea.
authors: Heung Jeong
authors: HJ
authors: Woo
authors: St. Vincent's Hospital, Catholic University of Korea College of Medicine, Suwon, Gyeonggi-do, Republic of Korea.
authors: Seong-Heon
authors: SH
authors: Wie
authors: Inha University College of Medicine, Incheon, Republic of Korea.
authors: Jin-Soo
authors: JS
authors: Lee
authors: Kyungpook National University School of Medicine, Daegu, Republic of Korea.
authors: Shin Woo
authors: SW
authors: Kim
authors: Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea; Transgovernmental Enterprise for Pandemic Influenza in Korea, Seoul, Republic of Korea.
authors: Ji Yun
authors: JY
authors: Noh
authors: Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.
authors: Won Suk
authors: WS
authors: Choi
authors: Life Science Research Institute, SK Chemicals, Seongnam, Gyeonggi-do, Republic of Korea.
authors: Hun
authors: H
authors: Kim
authors: Life Science Research Institute, SK Chemicals, Seongnam, Gyeonggi-do, Republic of Korea.
authors: Kyung-Ho
authors: KH
authors: Kim
authors: Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea; Transgovernmental Enterprise for Pandemic Influenza in Korea, Seoul, Republic of Korea. Electronic address: wjkim@korea.ac.kr.
authors: Woo Joo
authors: WJ
authors: Kim
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000914:Antibodies, Viral / Q000276:immunology; D018929:Cell Culture Techniques; D005260:Female; D006801:Humans; D009980:Influenza A virus / Q000276:immunology; D009981:Influenza B virus / Q000276:immunology*; D007252:Influenza Vaccines / Q000009:adverse effects / Q000276:immunology*; D007251:Influenza, Human / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D056910:Republic of Korea; D013997:Time Factors; D014611:Vaccination; D015164:Vaccines, Inactivated; D055815:Young Adult
chemical_list: D000914:Antibodies, Viral; D007252:Influenza Vaccines; D015164:Vaccines, Inactivated
keywords: Cell culture techniques; Human; Inactivated; Influenza; Influenza vaccines; Vaccines