PMID- 28302411
OWN - NLM
STAT- MEDLINE
DCOM- 20171214
LR  - 20220408
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Linking)
VI  - 35
IP  - 15
DP  - 2017 Apr 4
TI  - Immunogenicity and safety of a quadrivalent inactivated influenza vaccine 
      compared with two trivalent inactivated influenza vaccines containing alternate B 
      strains in adults: A phase 3, randomized noninferiority study.
PG  - 1856-1864
LID - S0264-410X(17)30291-8 [pii]
LID - 10.1016/j.vaccine.2017.02.066 [doi]
AB  - BACKGROUND: Vaccination is the most effective means of influenza prevention. 
      Efficacy of trivalent vaccines may be enhanced by including both B strain 
      lineages. This phase 3, double-blind study assessed the immunogenicity and 
      safety/tolerability of a quadrivalent inactivated influenza vaccine (IIV4) versus 
      the United States (US)-licensed 2014-2015 trivalent inactivated influenza vaccine 
      (IIV3-Yamagata [IIV3-YAM]; Afluria) and IIV3 containing the alternate Victoria B 
      strain (IIV3-VIC) in adults >/=18years. METHODS: Participants (n=3484) were 
      randomized 2:1:1 and stratified by age to receive IIV4 (n=1741), IIV3-YAM 
      (n=871), or IIV3-VIC (n=872). The primary objective was to demonstrate 
      noninferiority of the immunological response to IIV4 versus IIV3-YAM and 
      IIV3-VIC. Noninferiority was assessed by hemagglutination inhibition geometric 
      mean titer (GMT) ratio (IIV3/IIV4; upper bound of two-sided 95% confidence 
      interval [CI]</=1.5) and seroconversion rate (SCR) difference (IIV3 - IIV4; upper 
      bound of two-sided 95% CI</=10%) for vaccine strains. Solicited local and systemic 
      adverse events (AEs) were assessed for 7days postvaccination, AEs recorded for 
      28days postvaccination, and serious AEs for 6months postvaccination. RESULTS: 
      IIV4 elicited a noninferior immune response for matched strains, and superior 
      response for unmatched B strains not contained in IIV3 comparators. Adjusted GMT 
      ratios (95% CI) for A/H1N1, A/H3N2, B/YAM, and B/VIC strains were 0.93 (0.88, 
      0.99), 0.93 (0.88, 0.98), 0.87 (IIV3-YAM; 0.82, 0.93), and 0.95 (IIV3-VIC; 0.88, 
      1.03), respectively. Corresponding values for SCR differences (95% CI) were -1.1 
      (-4.5, 2.3), -1.7 (-5.0, 1.7), -3.2 (IIV3-YAM; -7.4, 0.9), and -1.6 (IIV3-VIC; 
      -5.8, 2.5). AEs were generally mild and experienced by 52.9% of participants. 
      Serious AEs were reported with a slightly higher frequency with IIV4 (2.3%) 
      versus IIV3-YAM (1.6%) and IIV3-VIC (1.5%). CONCLUSIONS: IIV4 demonstrated 
      immunological noninferiority to the US-licensed IIV3, and superiority for 
      unmatched B strains not contained in IIV3 comparators. Safety/tolerability 
      profiles were similar across vaccine groups. FUNDING: Seqirus; 
      Clinicaltrials.gov: NCT02214225.
CI  - Copyright (c) 2017. Published by Elsevier Ltd.
FAU - Treanor, John T
AU  - Treanor JT
AD  - University of Rochester Medical Center, School of Medicine and Dentistry, 
      Rochester, NY, United States.
FAU - Albano, Frank R
AU  - Albano FR
AD  - Clinical Development, Seqirus Pty Ltd, Parkville, Victoria, Australia. Electronic 
      address: frank.albano@seqirus.com.
FAU - Sawlwin, Daphne C
AU  - Sawlwin DC
AD  - Pharmacovigilance and Risk Management, Seqirus Pty Ltd, Parkville, Victoria, 
      Australia.
FAU - Graves Jones, Alison
AU  - Graves Jones A
AD  - Pharmacovigilance and Risk Management, Seqirus Pty Ltd, Parkville, Victoria, 
      Australia.
FAU - Airey, Jolanta
AU  - Airey J
AD  - Clinical Development, Seqirus Pty Ltd, Parkville, Victoria, Australia.
FAU - Formica, Neil
AU  - Formica N
AD  - Clinical Development, Seqirus Pty Ltd, Parkville, Victoria, Australia.
FAU - Matassa, Vince
AU  - Matassa V
AD  - Clinical Development, Seqirus Pty Ltd, Parkville, Victoria, Australia.
FAU - Leong, Jane
AU  - Leong J
AD  - Medical Affairs, Seqirus Pty Ltd, Parkville, Victoria, Australia.
LA  - eng
SI  - ClinicalTrials.gov/NCT02214225
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20170313
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  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies, Viral/blood
MH  - Double-Blind Method
MH  - Drug-Related Side Effects and Adverse Reactions/epidemiology/pathology
MH  - Female
MH  - Hemagglutination Inhibition Tests
MH  - Humans
MH  - Influenza Vaccines/administration & dosage/*adverse effects/*immunology
MH  - Male
MH  - Middle Aged
MH  - United States
MH  - Vaccines, Inactivated/administration & dosage/adverse effects/immunology
MH  - Young Adult
OTO - NOTNLM
OT  - Immunogenicity
OT  - Inactivated
OT  - Influenza vaccine
OT  - Noninferiority
OT  - Quadrivalent
OT  - Safety
EDAT- 2017/03/18 06:00
MHDA- 2017/12/15 06:00
CRDT- 2017/03/18 06:00
PHST- 2016/12/06 00:00 [received]
PHST- 2017/02/24 00:00 [revised]
PHST- 2017/02/28 00:00 [accepted]
PHST- 2017/03/18 06:00 [pubmed]
PHST- 2017/12/15 06:00 [medline]
PHST- 2017/03/18 06:00 [entrez]
AID - S0264-410X(17)30291-8 [pii]
AID - 10.1016/j.vaccine.2017.02.066 [doi]
PST - ppublish
SO  - Vaccine. 2017 Apr 4;35(15):1856-1864. doi: 10.1016/j.vaccine.2017.02.066. Epub 
      2017 Mar 13.