PMID- 28406746 OWN - NLM STAT- MEDLINE DCOM- 20180314 LR - 20181113 IS - 2164-554X (Electronic) IS - 2164-5515 (Print) IS - 2164-5515 (Linking) VI - 13 IP - 7 DP - 2017 Jul 3 TI - Immunogenicity and safety of a cell culture-derived inactivated quadrivalent influenza vaccine (NBP607-QIV): A randomized, double-blind, multi-center, phase III clinical trial in adults and elderly subjects. PG - 1653-1660 LID - 10.1080/21645515.2017.1297351 [doi] AB - BACKGROUND: The influenza B virus has two lineages; Yamagata and Victoria. The two lineages are antigenically distinct and it is difficult to expect cross-protection between the lineages. Actually, the mismatch between circulating influenza B viruses and vaccine strains has been occurred frequently. The cell-culture system for the production of influenza vaccine can contribute to improve vaccine strain selection and expand vaccine supplies. We investigated the immunogenicity and safety of cell culture-derived quadrivalent inactivated influenza vaccine (NBP607-QIV) in adults and elderly subjects. METHODS: A randomized controlled phase III trial was undertaken in 10 university hospitals in the Republic of Korea (Clinical trial Number-NCT02467842). Adults (aged 19-59 years) and elderly subjects (aged >/=60 years) were randomly assigned in a 2:1:1 ratio to NBP607-QIV versus cell culture-based trivalent inactivated influenza vaccine-Yamagata (NBP607-Y) and cell culture-based trivalent inactivated influenza vaccine-Victoria (NBP607-V). Immunogenicity was assessed 3 weeks after vaccination by hemagglutination inhibition assay. Safety was assessed for 6 months post-vaccination: solicited adverse events (AEs) for 7 days, unsolicited AEs for 21 days and serious adverse events (SAEs) for 6 months. AEs were sub-classified as adverse drug reactions (ADRs) according to the causality. RESULTS: A total of 1,503 participants were randomly assigned to NBP607-QIV (n = 752), NBP607-Y (n = 373) and NBP607-V (n = 378). The seroconversion rates of NBP607-QIV were 52.4%, 51.2%, 43.7% and 55.8% against A/H1N1, A/H3N2, B/Yamagata and B/Victoria, respectively. Non-inferiority against shared strains and superiority against alternate-lineage B strains were demonstrated for NBP607-QIV vs. NBP607-Y and NBP607-V. A total of 730 reactions occurred in 324 (43.1%) subjects of NBP607-QIV group. Majority of ADRs was solicited (99.2%) and mild (90.3%) in intensity. In adults (aged 19-59 years), solicited local AEs were slightly more frequent in NBP607-QIV group than NBP607-Y or NBP607-V group (40.9%, 33.4% and 32.5%, respectively). One SAE was observed among NBP607-QIV group, which was considered to be unrelated to the study vaccine within 3 weeks of vaccination and no vaccine-related SAEs were reported up to 6 months after vaccination. CONCLUSIONS: NBP607-QIV is a safe, well-tolerated and immunogenic influenza vaccine in Korean adults and elderly subjects. FAU - Choi, Won Suk AU - Choi WS AD - a Division of Infectious Diseases, Department of Internal Medicine , Korea University College of Medicine , Seoul , Republic of Korea. FAU - Noh, Ji Yun AU - Noh JY AD - a Division of Infectious Diseases, Department of Internal Medicine , Korea University College of Medicine , Seoul , Republic of Korea. FAU - Song, Joon Young AU - Song JY AD - a Division of Infectious Diseases, Department of Internal Medicine , Korea University College of Medicine , Seoul , Republic of Korea. FAU - Cheong, Hee Jin AU - Cheong HJ AD - a Division of Infectious Diseases, Department of Internal Medicine , Korea University College of Medicine , Seoul , Republic of Korea. FAU - Wie, Seong-Heon AU - Wie SH AD - b Division of Infectious Diseases, Department of Internal Medicine , St. Vincent's Hospital, College of Medicine, The Catholic University of Korea , Seoul , Republic of Korea. FAU - Lee, Jin Soo AU - Lee JS AD - c Division of Infectious Diseases, Department of Internal Medicine , Inha University Hospital, Inha University School of Medicine , Incheon , Republic of Korea. FAU - Lee, Jacob AU - Lee J AD - d Division of Infectious Diseases, Department of Internal Medicine , Hallym University College of Medicine , Chuncheon , Republic of Korea. FAU - Kim, Shin-Woo AU - Kim SW AD - e Division of Allergic and Infectious Diseases, Department of Internal Medicine , Kyungpook National University School of Medicine , Daegu , Republic of Korea. FAU - Jeong, Hye Won AU - Jeong HW AD - f Division of Infectious Diseases, Department of Internal Medicine , Chungbuk University Hospital, Chungbuk National University College of Medicine , Cheongju , Republic of Korea. FAU - Jung, Sook-In AU - Jung SI AD - g Division of Infectious Diseases , Chonnam National University Medical School , Gwangju , Republic of Korea. FAU - Kim, Yeon-Sook AU - Kim YS AD - h Divisoin of Infectious Diseases , Chungnam National University School of Medicine , Daejeon , Republic of Korea. FAU - Woo, Heung Jeong AU - Woo HJ AD - d Division of Infectious Diseases, Department of Internal Medicine , Hallym University College of Medicine , Chuncheon , Republic of Korea. FAU - Kim, Kyung Ho AU - Kim KH AD - i Life Science Research Institute, SK Chemicals , Seongnam , Gyeonggi-do , Republic of Korea. FAU - Kim, Hun AU - Kim H AD - i Life Science Research Institute, SK Chemicals , Seongnam , Gyeonggi-do , Republic of Korea. FAU - Kim, Woo Joo AU - Kim WJ AD - a Division of Infectious Diseases, Department of Internal Medicine , Korea University College of Medicine , Seoul , Republic of Korea. LA - eng SI - ClinicalTrials.gov/NCT02467842 PT - Clinical Trial, Phase III PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20170413 PL - United States TA - Hum Vaccin Immunother JT - Human vaccines & immunotherapeutics JID - 101572652 RN - 0 (Antibodies, Viral) RN - 0 (Influenza Vaccines) RN - 0 (Vaccines, Inactivated) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Antibodies, Viral/blood MH - Cell Culture Techniques MH - Double-Blind Method MH - Drug-Related Side Effects and Adverse Reactions/epidemiology/pathology MH - Female MH - Hemagglutination Inhibition Tests MH - Humans MH - Influenza B virus/*immunology MH - Influenza Vaccines/administration & dosage/*adverse effects/*immunology MH - Male MH - Middle Aged MH - Republic of Korea MH - Technology, Pharmaceutical MH - Vaccines, Inactivated/administration & dosage/adverse effects/immunology MH - Young Adult PMC - PMC5512784 OTO - NOTNLM OT - cell culture techniques OT - clinical trial OT - human OT - inactivated OT - influenza B virus OT - influenza vaccine OT - vaccine EDAT- 2017/04/14 06:00 MHDA- 2018/03/15 06:00 PMCR- 2018/04/13 CRDT- 2017/04/14 06:00 PHST- 2017/04/14 06:00 [pubmed] PHST- 2018/03/15 06:00 [medline] PHST- 2017/04/14 06:00 [entrez] PHST- 2018/04/13 00:00 [pmc-release] AID - 1297351 [pii] AID - 10.1080/21645515.2017.1297351 [doi] PST - ppublish SO - Hum Vaccin Immunother. 2017 Jul 3;13(7):1653-1660. doi: 10.1080/21645515.2017.1297351. Epub 2017 Apr 13.