PMID- 31335572
OWN - NLM
STAT- MEDLINE
DCOM- 20200514
LR  - 20200514
IS  - 1532-0987 (Electronic)
IS  - 0891-3668 (Linking)
VI  - 38
IP  - 9
DP  - 2019 Sep
TI  - A Randomized, Double-blind, Active-controlled Phase III Trial of a Cell 
      Culture-derived Quadrivalent Inactivated Influenza Vaccine in Healthy South 
      Korean Children and Adolescents 6 Months to 18 Years of Age.
PG  - e209-e215
LID - 10.1097/INF.0000000000002406 [doi]
AB  - BACKGROUND: Cell culture-derived influenza vaccines have several important 
      advantages over egg-based influenza vaccines. The quadrivalent influenza vaccine 
      may offer broader protection against seasonal influenza than trivalent influenza 
      vaccine by containing 1 more B strain. The purpose of this study was to evaluate 
      the immunogenicity and safety of NBP607-QIV, a novel cell culture-derived 
      inactivated quadrivalent influenza vaccine (cIIV4), in children and adolescents. 
      METHODS: This phase III, randomized, double-blind, multicenter trial in 
      children/adolescents (6 mo to 18 yr) was conducted in South Korea during 
      2014-2015 season. Subjects were randomized 4:1 to receive either NBP607-QIV or 
      control inactivated trivalent influenza vaccine. Hemagglutination inhibition 
      antibody titers were assessed in prevaccination and 28 days postvaccination sera. 
      Safety data were collected for up to 6 months postvaccination. RESULTS: A total 
      of 454 participants completed the study. Three-hundred sixty-six subjects 
      received cIIV4 and 88 subjects received inactivated trivalent influenza vaccine. 
      Overall, NBP607-QIV met the immunogenicity criteria of Committee for Medicinal 
      Products for Human Use for each of the 4 strains. Between the NBP607-QIV and 
      control groups, immunogenicity endpoints were comparable. Participants younger 
      than 3 years of age had lower immunologic responses to 2 influenza B strains in 
      both NBP607-QIV and control group. No deaths, vaccine-related serious adverse 
      events (AEs) or withdrawals because of AEs were reported. The solicited AEs 
      reported were generally of mild intensity. CONCLUSIONS: NBP607-QIV, a novel 
      cIIV4, showed good immunogenicity to all 4 influenza strains and had tolerable 
      safety profiles in children and adolescents. Moreover, NBP607-QIV was more 
      immunogenic against influenza B compared with the control, an egg-based subunit 
      vaccine.
FAU - Eun, Byung Wook
AU  - Eun BW
AD  - From the Department of Pediatrics, Eulji University Eulji General Hospital, 
      Seoul, Republic of Korea.
FAU - Lee, Taek Jin
AU  - Lee TJ
AD  - Department of Pediatrics, CHA Bundang Medical Center, CHA University, Seongnam, 
      Republic of Korea.
FAU - Lee, Jina
AU  - Lee J
AD  - Department of Pediatrics, Asan Medical Center, University of Ulsan College of 
      Medicine.
FAU - Kim, Ki Hwan
AU  - Kim KH
AD  - Department of Pediatrics, Severance Children's Hospital, Yonsei University 
      College of Medicine.
FAU - Kim, Dong Ho
AU  - Kim DH
AD  - Department of Pediatrics, Korea Cancer Center Hospital, Seoul, Republic of Korea.
FAU - Jo, Dae Sun
AU  - Jo DS
AD  - Department of Pediatrics, Chonbuk National University Children's Hospital, 
      Chonbuk National University Medical School, Jeonju, Republic of Korea.
FAU - Shin, Sun Hee
AU  - Shin SH
AD  - Department of Pediatrics, Dongtan Sacred Heart Hospital.
FAU - Kim, Hun
AU  - Kim H
AD  - SK Bioscience, Seongnam.
FAU - Kim, Kyung-Ho
AU  - Kim KH
AD  - SK Bioscience, Seongnam.
FAU - Kim, Yun-Kyung
AU  - Kim YK
AD  - Department of Pediatrics, Korea University Ansan Hospital, Gyeonggi-do, Republic 
      of Korea.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Pediatr Infect Dis J
JT  - The Pediatric infectious disease journal
JID - 8701858
RN  - 0 (Antibodies, Viral)
RN  - 0 (Influenza Vaccines)
RN  - 0 (Vaccines, Inactivated)
SB  - IM
MH  - Adolescent
MH  - Animals
MH  - Antibodies, Viral/blood
MH  - Child
MH  - Child, Preschool
MH  - Dogs
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - *Immunogenicity, Vaccine
MH  - Infant
MH  - Influenza Vaccines/administration & dosage/*immunology
MH  - Influenza, Human/*prevention & control
MH  - Madin Darby Canine Kidney Cells
MH  - Male
MH  - Republic of Korea
MH  - Seasons
MH  - Vaccines, Inactivated/administration & dosage/immunology
MH  - Virus Cultivation
EDAT- 2019/07/25 06:00
MHDA- 2020/05/15 06:00
CRDT- 2019/07/24 06:00
PHST- 2019/07/25 06:00 [pubmed]
PHST- 2020/05/15 06:00 [medline]
PHST- 2019/07/24 06:00 [entrez]
AID - 10.1097/INF.0000000000002406 [doi]
PST - ppublish
SO  - Pediatr Infect Dis J. 2019 Sep;38(9):e209-e215. doi: 
      10.1097/INF.0000000000002406.