PMID- 33736920 OWN - NLM STAT- MEDLINE DCOM- 20210524 LR - 20210524 IS - 1873-2518 (Electronic) IS - 0264-410X (Linking) VI - 39 IP - 15 DP - 2021 Apr 8 TI - Active-controlled phase III study of an egg-cultivated quadrivalent inactivated split-virion influenza vaccine (GC3110A) in healthy Korean children aged 6-35 months. PG - 2103-2109 LID - S0264-410X(21)00273-5 [pii] LID - 10.1016/j.vaccine.2021.03.005 [doi] AB - The inactivated trivalent influenza vaccine (TIV) offers limited protection when two influenza B lineages co-circulate or when there is a vaccine mismatch (i.e., discordance in the predominant circulating B strain and WHO-recommended B strain). Inactivated quadrivalent influenza vaccine (QIV) may reduce the burden of influenza. Here, we report the results of a phase 3 clinical trial that evaluated the immunogenicity and safety of a novel QIV, GC3110A, in Korean children aged 6-35 months, which has been approved and is currently in use in Korea. The study involved two parts. In Part 1, the safety of GC3110A was evaluated in 10 subjects. After none of the subjects reported grade 3 adverse events (AEs), we proceeded to Part 2. Part 2 was a randomized, double-blind, multicenter phase 3 trial wherein we compared the immunogenicity and safety of GC3110A with those of a licensed control TIV. Immunogenicity was evaluated by measuring hemagglutination inhibition titers. The 200 participants enrolled in Part 2 were randomized in a 4:1 ratio to receive GC3110A or control TIV. The study vaccine group met both primary (i.e., the lower limit of 95% confidence interval [CI] of the seroconversion rate exceeds 40% for four strains) and secondary (i.e., the lower limit of 95% CI of the seroprotection rate exceeds 70% for four strains) immunogenicity endpoints. There was no significant between-group difference in the seroconversion rate, seroprotection rate, and geometric mean titer for the shared strains. However, the study vaccine group demonstrated significantly higher immunity for the additional strain B/Yamagata. In the safety analysis, there was no significant between-group difference in the proportion of participants with solicited local AEs, solicited systemic AEs, and unsolicited AEs. In conclusion, the results indicate that GC3110A has comparable immunogenicity and safety to those of TIV. Clinical Trial Registry Number: NCT03285997. CI - Copyright (c) 2021 Elsevier Ltd. All rights reserved. FAU - Choi, Ui Yoon AU - Choi UY AD - Department of Pediatrics, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 1021, Tongil-ro, Eunpyeong-gu, Seoul, 03312, Republic of Korea. Electronic address: uiyoon@catholic.ac.kr. FAU - Kim, Ki Hwan AU - Kim KH AD - Department of Pediatrics, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea. Electronic address: poohwa99@gmail.com. FAU - Lee, Kyung Yil AU - Lee KY AD - Department of Pediatrics, Daejeon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea. Electronic address: leekyungyil@catholic.ac.kr. FAU - Kim, Jong-Hyun AU - Kim JH AD - Department of Pediatrics, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea. Electronic address: jh00mn@catholic.ac.kr. FAU - Kim, Chun Soo AU - Kim CS AD - Department of Pediatrics, Dongsan Medical Center, Keimyung University School of Medicine, Daegu, Republic of Korea. Electronic address: cskim@dsmc.or.kr. FAU - Eun, Byung Wook AU - Eun BW AD - Department of Pediatrics, Nowon Eulji Medical Center, Eulji University School of Medicine, Seoul, Republic of Korea. Electronic address: acet0125@hanmail.net. FAU - Kim, Hwang Min AU - Kim HM AD - Department of Pediatrics, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea. Electronic address: khm9120@yonsei.ac.kr. FAU - Kim, Dong Ho AU - Kim DH AD - Department of Pediatrics, Korea Cancer Center Hospital, Seoul, Republic of Korea. Electronic address: kdh281920@gmail.com. FAU - Song, Song Eun AU - Song SE AD - Department of Pediatrics, Chonnam National University Children's Hospital, Gwangju, Republic of Korea. Electronic address: essong@jnu.ac.kr. FAU - Jo, Dae Sun AU - Jo DS AD - Department of Pediatrics, Chonbuk National University Children's Hospital, Jeonju, Republic of Korea. Electronic address: drjo@chonbuk.ac.kr. FAU - Lee, Jin AU - Lee J AD - Department of Pediatrics, Hanil General Hospital, Seoul, Republic of Korea. Electronic address: pedleejin@naver.com. FAU - Ma, Sang Hyuk AU - Ma SH AD - Department of Pediatrics, Changwon Fatima Hospital, Changwon, Republic of Korea. Electronic address: msh6517@hanmail.net. FAU - Kim, Kwang Nam AU - Kim KN AD - Department of Pediatrics, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea. Electronic address: kwangkim52@hanmail.net. FAU - Kang, Jin Han AU - Kang JH AD - Department of Pediatrics, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea; Vaccine Bio Research Institute, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea. Electronic address: kjhan@catholic.ac.kr. LA - eng SI - ClinicalTrials.gov/NCT03285997 PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20210316 PL - Netherlands TA - Vaccine JT - Vaccine JID - 8406899 RN - 0 (Antibodies, Viral) RN - 0 (Influenza Vaccines) RN - 0 (Vaccines, Inactivated) SB - IM MH - Antibodies, Viral MH - Child MH - Child, Preschool MH - Double-Blind Method MH - Hemagglutination Inhibition Tests MH - Humans MH - Immunogenicity, Vaccine MH - Infant MH - Influenza B virus MH - *Influenza Vaccines/adverse effects MH - *Influenza, Human/prevention & control MH - Republic of Korea MH - Vaccines, Inactivated/adverse effects MH - Virion OTO - NOTNLM OT - Children OT - Immunogenicity OT - Quadrivalent inactivated influenza vaccine OT - Safety COIS- Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: JH Kang's institution has received research grants from GC Pharma (Yoingin, Korea). Except that, they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. EDAT- 2021/03/20 06:00 MHDA- 2021/05/25 06:00 CRDT- 2021/03/19 06:11 PHST- 2020/08/07 00:00 [received] PHST- 2021/02/26 00:00 [revised] PHST- 2021/03/02 00:00 [accepted] PHST- 2021/03/20 06:00 [pubmed] PHST- 2021/05/25 06:00 [medline] PHST- 2021/03/19 06:11 [entrez] AID - S0264-410X(21)00273-5 [pii] AID - 10.1016/j.vaccine.2021.03.005 [doi] PST - ppublish SO - Vaccine. 2021 Apr 8;39(15):2103-2109. doi: 10.1016/j.vaccine.2021.03.005. Epub 2021 Mar 16.