PMID- 28870140
OWN - NLM
STAT- MEDLINE
DCOM- 20180529
LR  - 20180613
IS  - 1744-8395 (Electronic)
IS  - 1476-0584 (Linking)
VI  - 16
IP  - 11
DP  - 2017 Nov
TI  - Immunogenicity and safety of an inactivated quadrivalent influenza vaccine 
      candidate versus inactivated trivalent influenza vaccines in participants >/=3 
      years of age: a double-blind, randomized, parallel-controlled phase III clinical 
      trial in China.
PG  - 1155-1169
LID - 10.1080/14760584.2017.1374181 [doi]
AB  - BACKGROUND: Viruses from two antigenically distinct influenza B strains have 
      co-circulated since the mid-1980s, yet inactivated trivalent influenza vaccines 
      (TIVs) with either the Victoria or Yamagata lineage could only provide limited 
      protection from influenza B strain. Quadrivalent influenza vaccine (QIV) 
      including both influenza B lineages can improve protection against circulating 
      influenza B viruses. METHODS: Participants >/ = 3 years of age were recruited, 
      stratified by age, and then randomly allocated at a ratio of 2:1:1 to receive 
      one-injection of the experimental QIV, TIV-Victoria (Vic) or TIV-Yamagata (Yam). 
      The primary objective of this study was to demonstrate that the 
      hemagglutination-inhibition (HI) antibodies induced by the QIV candidate are not 
      inferior to the licensed TIVs. RESULTS: First, 3661 participants received the 
      inoculation. The QIV was found to be non-inferior to TIVs in terms of the 
      geometric mean titers (GMTs) and seroconversion rates (SCRs) of the HI antibodies 
      against shared strains 28 days after completion of inoculation, and was superior 
      to the TIVs against the alternate B strain, which is absent from the TIVs. The 
      occurrences of adverse events (AEs) post-vaccination were similar across the 
      treatment groups. CONCLUSION: The experimental QIV showed good immunogenicity and 
      an acceptable safety profile.
FAU - Wang, Shi-Yuan
AU  - Wang SY
AD  - a Department of Public Health , Southeast University , Nanjing , PR China.
FAU - Liu, Shu-Zhen
AU  - Liu SZ
AD  - b Department of Respiratory Virus Vaccine , National Institutes for Food and Drug 
      Control , Beijing , PR China.
FAU - Chu, Kai
AU  - Chu K
AD  - c Vaccine Clinical Evaluation Department , Jiangsu Provincial Center for Disease 
      Control and Prevention , Nanjing , PR China.
FAU - Zhao, Yue
AU  - Zhao Y
AD  - d Corporate Representative , Jiangsu GDK Biotechnology Co., Ltd , Taizhou , PR 
      China.
FAU - Zhu, Feng-Cai
AU  - Zhu FC
AD  - c Vaccine Clinical Evaluation Department , Jiangsu Provincial Center for Disease 
      Control and Prevention , Nanjing , PR China.
FAU - Hu, Yue-Mei
AU  - Hu YM
AD  - c Vaccine Clinical Evaluation Department , Jiangsu Provincial Center for Disease 
      Control and Prevention , Nanjing , PR China.
FAU - Meng, Fan-Yue
AU  - Meng FY
AD  - c Vaccine Clinical Evaluation Department , Jiangsu Provincial Center for Disease 
      Control and Prevention , Nanjing , PR China.
FAU - Li, Jing-Xin
AU  - Li JX
AD  - c Vaccine Clinical Evaluation Department , Jiangsu Provincial Center for Disease 
      Control and Prevention , Nanjing , PR China.
FAU - Luo, Li
AU  - Luo L
AD  - a Department of Public Health , Southeast University , Nanjing , PR China.
FAU - Yang, Jia-Ying
AU  - Yang JY
AD  - a Department of Public Health , Southeast University , Nanjing , PR China.
FAU - Liu, Pei
AU  - Liu P
AD  - a Department of Public Health , Southeast University , Nanjing , PR China.
FAU - Yu, Jun
AU  - Yu J
AD  - d Corporate Representative , Jiangsu GDK Biotechnology Co., Ltd , Taizhou , PR 
      China.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20170918
PL  - England
TA  - Expert Rev Vaccines
JT  - Expert review of vaccines
JID - 101155475
RN  - 0 (Antibodies, Viral)
RN  - 0 (Influenza Vaccines)
RN  - 0 (Vaccines, Inactivated)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies, Viral/blood
MH  - Child
MH  - Child, Preschool
MH  - China
MH  - Double-Blind Method
MH  - Drug-Related Side Effects and Adverse Reactions/epidemiology
MH  - Female
MH  - Hemagglutination Inhibition Tests
MH  - Humans
MH  - Influenza Vaccines/administration & dosage/*adverse effects/*immunology
MH  - Male
MH  - Middle Aged
MH  - Seroconversion
MH  - Vaccines, Inactivated/administration & dosage/adverse effects/immunology
MH  - Young Adult
OTO - NOTNLM
OT  - Quadrivalent influenza vaccine
OT  - Victoria lineage
OT  - Yamagata lineage
OT  - clinical trial
OT  - immunogenicity
OT  - safety
OT  - seasonal influenza
EDAT- 2017/09/06 06:00
MHDA- 2018/05/31 06:00
CRDT- 2017/09/06 06:00
PHST- 2017/09/06 06:00 [pubmed]
PHST- 2018/05/31 06:00 [medline]
PHST- 2017/09/06 06:00 [entrez]
AID - 10.1080/14760584.2017.1374181 [doi]
PST - ppublish
SO  - Expert Rev Vaccines. 2017 Nov;16(11):1155-1169. doi: 
      10.1080/14760584.2017.1374181. Epub 2017 Sep 18.