PMID- 30396317
OWN - NLM
STAT- MEDLINE
DCOM- 20200226
LR  - 20200309
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 15
IP  - 3
DP  - 2019
TI  - Immunogenicity and safety of an egg-based inactivated quadrivalent influenza 
      vaccine (GC3110A) versus two inactivated trivalent influenza vaccines with 
      alternate B strains: A phase Ⅲ randomized clinical trial in adults.
PG  - 710-716
LID - 10.1080/21645515.2018.1536589 [doi]
AB  - Two antigenically distinct influenza B lineage viruses (Yamagata/Victoria) have 
      been co-circulating globally since the mid-1980s. The quadrivalent influenza 
      vaccine (QIV) may provide better protection against unpredictable B strains. We 
      conducted a randomized, double-blind, phase III trial to evaluate the 
      immunogenicity and safety of an egg-based inactivated, split-virion QIV 
      (GC3110A). Subjects aged >/= 19 years were randomized 2:1:1 to be vaccinated with 
      QIV- GC3110A, trivalent influenza vaccine (TIV) containing the Yamagata lineage 
      strain (TIV-Yamagata), or TIV containing the Victoria lineage strain 
      (TIV-Victoria). Hemagglutination inhibition assays were performed 21 days 
      post-vaccination. Solicited/unsolicited adverse events (AEs) were assessed within 
      21 days after vaccination, while serious AEs were reported up to six months after 
      vaccination. A total of 1,299 were randomized to receive QIV-GC3110A (648 
      subjects), TIV-Yamagata (325 subjects), or TIV-Victoria (326 subjects). Compared 
      to the TIVs, the QIV-GC3110A met the non-inferiority criteria for all four 
      subtype/lineage strains with respect to the geometric mean titer (GMT) ratio and 
      the difference of seroconversion rate. The safety profiles of QIV-GC3110A were 
      consistent with those of TIV. In conclusion, QIV-GC3110A is safe, immunogenic, 
      and comparable to strain-matched TIV.
FAU - Song, Joon Young
AU  - Song JY
AUID- ORCID: 0000-0002-0148-7194
AD  - a Division of Infectious Diseases, Department of Internal Medicine , Korea 
      University College of Medicine1 , Seoul , Korea.
FAU - Lee, Jacob
AU  - Lee J
AD  - b Division of Infectious Diseases, Department of Internal Medicine, Kangnam 
      Sacred Heart Hospital , Hallym University College of Medicine , Seoul , Korea.
FAU - Woo, Heung Jeong
AU  - Woo HJ
AD  - c Division of Infectious Diseases, Department of Internal Medicine, Dongtan 
      Sacred Heart Hospital , Hallym University College of Medicine , Hwasung , Korea.
FAU - Wie, Seong-Heon
AU  - Wie SH
AD  - d Division of Infectious Diseases, Department of Internal Medicine , Catholic 
      University Medical College, St. Vincent's Hospital , Suwon , Korea.
FAU - Lee, Jin Soo
AU  - Lee JS
AD  - e Division of Infectious Diseases, Department of Internal Medicine , Inha 
      University College of Medicine , Incheon , Korea.
FAU - Kim, Shin Woo
AU  - Kim SW
AD  - f Division of Infectious Diseases, Department of Internal Medicine , Kyungpook 
      National University School of Medicine , Daegu , Korea.
FAU - Kim, Tae Hyong
AU  - Kim TH
AD  - g Division of Infectious Diseases, Department of Internal Medicine , Soon Chun 
      Hyang University Hospital, Soon Chun Hyang University College of Medicine , Seoul 
      , Korea.
FAU - Jung, Sook-In
AU  - Jung SI
AD  - h Division of Infectious Diseases, Department of Internal Medicine, Chonnam 
      National University Medical School , Chonnam National University Hospital , 
      Gwangju , Korea.
FAU - Noh, Ji Yun
AU  - Noh JY
AD  - a Division of Infectious Diseases, Department of Internal Medicine , Korea 
      University College of Medicine1 , Seoul , Korea.
FAU - Choi, Won Suk
AU  - Choi WS
AD  - a Division of Infectious Diseases, Department of Internal Medicine , Korea 
      University College of Medicine1 , Seoul , Korea.
FAU - Cheong, Hee Jin
AU  - Cheong HJ
AD  - a Division of Infectious Diseases, Department of Internal Medicine , Korea 
      University College of Medicine1 , Seoul , Korea.
FAU - Kim, Woo Joo
AU  - Kim WJ
AD  - a Division of Infectious Diseases, Department of Internal Medicine , Korea 
      University College of Medicine1 , Seoul , 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
DEP - 20181115
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Antibodies, Viral)
RN  - 0 (Antigens, Viral)
RN  - 0 (Influenza Vaccines)
RN  - 0 (Vaccines, Inactivated)
SB  - IM
MH  - Adult
MH  - Antibodies, Viral/*blood
MH  - Antigens, Viral/chemistry/immunology
MH  - Double-Blind Method
MH  - Drug-Related Side Effects and Adverse Reactions
MH  - Eggs
MH  - Female
MH  - Humans
MH  - *Immunogenicity, Vaccine
MH  - Influenza A virus/*immunology
MH  - Influenza B virus/*immunology
MH  - Influenza Vaccines/chemistry/*immunology
MH  - Influenza, Human/prevention & control
MH  - Male
MH  - Middle Aged
MH  - Seroconversion
MH  - Vaccination
MH  - Vaccines, Inactivated/chemistry/immunology
PMC - PMC6605850
OTO - NOTNLM
OT  - Inactivated quadrivalent influenza vaccine
OT  - Influenza B
OT  - victoria lineage
OT  - yamagata lineage
EDAT- 2018/11/07 06:00
MHDA- 2020/02/27 06:00
PMCR- 2019/11/15
CRDT- 2018/11/07 06:00
PHST- 2018/11/07 06:00 [pubmed]
PHST- 2020/02/27 06:00 [medline]
PHST- 2018/11/07 06:00 [entrez]
PHST- 2019/11/15 00:00 [pmc-release]
AID - 1536589 [pii]
AID - 10.1080/21645515.2018.1536589 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2019;15(3):710-716. doi: 10.1080/21645515.2018.1536589. 
      Epub 2018 Nov 15.