PMID- 26585940
OWN - NLM
STAT- MEDLINE
DCOM- 20160906
LR  - 20181202
IS  - 1878-3511 (Electronic)
IS  - 1201-9712 (Linking)
VI  - 41
DP  - 2015 Dec
TI  - Non-inferiority of mammalian cell-derived quadrivalent subunit influenza virus 
      vaccines compared to trivalent subunit influenza virus vaccines in healthy 
      children: a phase III randomized, multicenter, double-blind clinical trial.
PG  - 65-72
LID - S1201-9712(15)00264-7 [pii]
LID - 10.1016/j.ijid.2015.11.004 [doi]
AB  - OBJECTIVES: The safety and immunogenicity of mammalian cell-derived quadrivalent 
      influenza vaccine (QIVc) as compared with trivalent influenza vaccines 
      (TIV1c/TIV2c) was evaluated in children aged >/=4 to <18 years. METHODS: Two 
      thousand three hundred and thirty-three subjects were randomized 2:1:1 to receive 
      either one or two doses of study vaccine depending on previous vaccination 
      status. Hemagglutination inhibition antibody responses for all four influenza 
      strains were performed 3 weeks after the last dose. Reactogenicity and safety 
      were also assessed (ClinicalTrials.gov: NCT01992107). RESULTS: QIVc met the 
      non-inferiority criteria against all four vaccine strains and demonstrated 
      superiority for both influenza B strains over the unmatched B lineage included in 
      the comparator vaccines, when geometric mean titers and seroconversion rates were 
      compared at 3 weeks after the last vaccination. Similar percentages of subjects 
      experienced solicited and unsolicited adverse events (AEs) across all subgroups. 
      Unsolicited AEs, serious AEs, medically attended AEs, and new onset chronic 
      disease were reported in comparable percentages of subjects in all study groups. 
      No vaccine-related serious AEs or deaths occurred. CONCLUSIONS: QIVc demonstrated 
      a similar safety profile and immunogenicity responses against all four vaccine 
      strains without signs of immune interference on addition of an alternate lineage 
      B strain compared with TIV1c/TIV2c and may provide broader protection against 
      both influenza B lineages in children.
CI  - Copyright (c) 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.
FAU - Hartvickson, Robyn
AU  - Hartvickson R
AD  - Heartland Research Associates, LLC, Newton, Kansas, USA.
FAU - Cruz, Marilou
AU  - Cruz M
AD  - Premier Health Research Center, LLC, Downey, California, USA.
FAU - Ervin, John
AU  - Ervin J
AD  - The Center for Pharmaceutical Research, Kansas City, Missouri, USA.
FAU - Brandon, Donald
AU  - Brandon D
AD  - California Research Foundation, San Diego, California, USA.
FAU - Forleo-Neto, Eduardo
AU  - Forleo-Neto E
AD  - Novartis Vaccines and Diagnostics Inc., Cambridge, Massachusetts, USA.
FAU - Dagnew, Alemnew F
AU  - Dagnew AF
AD  - Novartis Vaccines and Diagnostics Inc., Cambridge, Massachusetts, USA.
FAU - Chandra, Richa
AU  - Chandra R
AD  - Novartis Vaccines and Diagnostics Inc., Cambridge, Massachusetts, USA.
FAU - Lindert, Kelly
AU  - Lindert K
AD  - Novartis Vaccines and Diagnostics Inc., Cambridge, Massachusetts, USA.
FAU - Mateen, Ahmed Abdul
AU  - Mateen AA
AD  - Novartis Pharmaceuticals Canada Inc., 385 Bouchard Blvd, Dorval, Quebec, H9S 1A9, 
      Canada. Electronic address: ahmed.abdul_mateen@novartis.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT01992107
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20151114
PL  - Canada
TA  - Int J Infect Dis
JT  - International journal of infectious diseases : IJID : official publication of the 
      International Society for Infectious Diseases
JID - 9610933
RN  - 0 (Antibodies, Viral)
RN  - 0 (Influenza Vaccines)
RN  - 0 (Vaccines, Inactivated)
SB  - IM
MH  - Adolescent
MH  - Antibodies, Viral/blood
MH  - Antibody Formation
MH  - Child
MH  - Child, Preschool
MH  - Double-Blind Method
MH  - Female
MH  - Hemagglutination Inhibition Tests
MH  - Humans
MH  - Influenza Vaccines/*immunology
MH  - Influenza, Human/*prevention & control
MH  - Male
MH  - Seroconversion
MH  - Vaccination
MH  - Vaccines, Inactivated/immunology
OTO - NOTNLM
OT  - Influenza
OT  - MDCK
OT  - Pediatric
OT  - Quadrivalent
OT  - Trivalent
OT  - Vaccine
EDAT- 2015/11/21 06:00
MHDA- 2016/09/07 06:00
CRDT- 2015/11/21 06:00
PHST- 2015/07/25 00:00 [received]
PHST- 2015/11/05 00:00 [revised]
PHST- 2015/11/06 00:00 [accepted]
PHST- 2015/11/21 06:00 [entrez]
PHST- 2015/11/21 06:00 [pubmed]
PHST- 2016/09/07 06:00 [medline]
AID - S1201-9712(15)00264-7 [pii]
AID - 10.1016/j.ijid.2015.11.004 [doi]
PST - ppublish
SO  - Int J Infect Dis. 2015 Dec;41:65-72. doi: 10.1016/j.ijid.2015.11.004. Epub 2015 
      Nov 14.