PMID- 32284272
OWN - NLM
STAT- MEDLINE
DCOM- 20210413
LR  - 20210413
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Linking)
VI  - 38
IP  - 22
DP  - 2020 May 8
TI  - Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in 
      healthy subjects aged 3 to 17 years old: A phase III, open label, single-arm 
      study.
PG  - 3839-3846
LID - S0264-410X(20)30437-0 [pii]
LID - 10.1016/j.vaccine.2020.03.048 [doi]
AB  - BACKGROUND: Quadrivalent influenza vaccines are particularly valuable during 
      seasons in which a mismatch occurs between the predicted influenza B lineage for 
      the trivalent influenza vaccine and the circulating strain. This study evaluated 
      the immunogenicity and safety of a quadrivalent inactivated influenza vaccine 
      AdimFlu-S manufactured in Taiwan for the 2016-2017 influenza season in healthy 
      children. METHODS: A total of 174 healthy children aged 3 to 17 years old were 
      separated into 3 groups (Group A: 3-8 years old, vaccine naive; Group B: 
      3-8 years old, vaccine non-naive; Group C: 9-17 years old, any vaccine status). 
      Sera was collected pre and post vaccination for each participant. A 
      hemagglutination inhibition (HAI) assay was utilized to calculate geometric mean 
      titer (GMT), seroprotection rate, and seroconversion rate. RESULTS: All enrolled 
      participants completed the study. For the four vaccine strains four weeks after 
      the last vaccination, geometric mean titer ratios (GMTRs) were between 2.9 and 
      20.9, seroconversion rates were between 42.9% and 90.9%, and seroprotection rates 
      were all above 96.4%. This achieved all immunogenicity endpoints and fulfilled 
      the criteria of the European Medical Agency's Committee for Medicinal Products 
      for Human Use (CHMP). No serious adverse events (AEs) were reported during the 
      follow-up period of 6 months. CONCLUSION: This quadrivalent influenza vaccine is 
      demonstrated to be well tolerated and displays robust immunogenicity for each 
      influenza strain. This could potentially improve protection against the 
      antigenically distinct B/Yamagata and B/Victoria lineages.
CI  - Copyright (c) 2020 Elsevier Ltd. All rights reserved.
FAU - Chang, Chia-Yuan
AU  - Chang CY
AD  - Division of Infectious Diseases, Department of Pediatrics, Taipei Veterans 
      General Hospital and National Yang-Ming University, Taipei, Taiwan.
FAU - Cho, Ching-Yi
AU  - Cho CY
AD  - Division of Infectious Diseases, Department of Pediatrics, Taipei Veterans 
      General Hospital and National Yang-Ming University, Taipei, Taiwan.
FAU - Lai, Chou-Cheng
AU  - Lai CC
AD  - Division of Infectious Diseases, Department of Pediatrics, Taipei Veterans 
      General Hospital and National Yang-Ming University, Taipei, Taiwan.
FAU - Lu, Chun-Yi
AU  - Lu CY
AD  - Departments of Pediatrics, National Taiwan University Children's Hospital and 
      National Taiwan University College of Medicine, Taipei, Taiwan.
FAU - Chang, Luan-Yin
AU  - Chang LY
AD  - Departments of Pediatrics, National Taiwan University Children's Hospital and 
      National Taiwan University College of Medicine, Taipei, Taiwan.
FAU - Hung, Miao-Chiu
AU  - Hung MC
AD  - Division of Infectious Diseases, Department of Pediatrics, Taipei Veterans 
      General Hospital and National Yang-Ming University, Taipei, Taiwan.
FAU - Huang, Li-Min
AU  - Huang LM
AD  - Departments of Pediatrics, National Taiwan University Children's Hospital and 
      National Taiwan University College of Medicine, Taipei, Taiwan. Electronic 
      address: lmhuang@ntu.edu.tw.
FAU - Wu, Keh-Gong
AU  - Wu KG
AD  - Division of Infectious Diseases, Department of Pediatrics, Taipei Veterans 
      General Hospital and National Yang-Ming University, Taipei, Taiwan. Electronic 
      address: kgwu@vghtpe.gov.tw.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20200410
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Antibodies, Viral)
RN  - 0 (Influenza Vaccines)
RN  - 0 (Vaccines, Inactivated)
SB  - IM
MH  - Adolescent
MH  - Antibodies, Viral/*blood
MH  - Child
MH  - Child, Preschool
MH  - Healthy Volunteers
MH  - Hemagglutination Inhibition Tests
MH  - Humans
MH  - *Immunogenicity, Vaccine
MH  - Influenza B virus/immunology
MH  - Influenza Vaccines/adverse effects/*immunology
MH  - *Influenza, Human/prevention & control
MH  - Taiwan
MH  - Vaccines, Inactivated/adverse effects/immunology
OTO - NOTNLM
OT  - Children
OT  - Immunogenicity
OT  - Influenza
OT  - Quadrivalent
OT  - Safety
OT  - Split viron vaccine
COIS- Declaration of Competing Interest The authors declare that they have no known 
      competing financial interests or personal relationships that could have appeared 
      to influence the work reported in this paper.
EDAT- 2020/04/15 06:00
MHDA- 2021/04/14 06:00
CRDT- 2020/04/15 06:00
PHST- 2019/12/13 00:00 [received]
PHST- 2020/03/20 00:00 [revised]
PHST- 2020/03/27 00:00 [accepted]
PHST- 2020/04/15 06:00 [pubmed]
PHST- 2021/04/14 06:00 [medline]
PHST- 2020/04/15 06:00 [entrez]
AID - S0264-410X(20)30437-0 [pii]
AID - 10.1016/j.vaccine.2020.03.048 [doi]
PST - ppublish
SO  - Vaccine. 2020 May 8;38(22):3839-3846. doi: 10.1016/j.vaccine.2020.03.048. Epub 
      2020 Apr 10.