PMID- 23228813
OWN - NLM
STAT- MEDLINE
DCOM- 20130701
LR  - 20220408
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Linking)
VI  - 31
IP  - 5
DP  - 2013 Jan 21
TI  - Safety and immunogenicity of a quadrivalent inactivated influenza vaccine 
      compared to licensed trivalent inactivated influenza vaccines in adults.
PG  - 770-6
LID - S0264-410X(12)01724-0 [pii]
LID - 10.1016/j.vaccine.2012.11.074 [doi]
AB  - PURPOSE: To evaluate the safety and immunogenicity of a prototype quadrivalent 
      inactivated influenza vaccine (QIV) containing two influenza B strains, one of 
      each lineage, compared with licensed trivalent inactivated influenza vaccines 
      (TIVs) containing either a Victoria B-lineage strain (2009-2010 TIV) or a 
      Yamagata B-lineage strain (2008-2009 TIV). METHODS: Healthy adults >/=18 years of 
      age were eligible to participate in this phase II, open-label, randomized, 
      controlled, multicenter study conducted in the US. Participants received a single 
      dose of 2009-2010 TIV, 2008-2009 TIV, or QIV. Sera were collected before and 21 
      days after vaccine administration to test for hemagglutination inhibition (HAI) 
      antibodies to each of the four influenza strains. Immunogenicity endpoints 
      included geometric mean HAI antibody titers (GMTs) and rates of seroprotection 
      (titer >/=1:40) and seroconversion (4-fold rise pre- to post-vaccination). Safety 
      endpoints included frequency of solicited injection-site and systemic reactions 
      occurring within 3 days of vaccination, and unsolicited non-serious adverse 
      events (AEs) and serious AEs (SAEs) within 21 days of vaccination. RESULTS: One 
      hundred and ninety participants were enrolled to each vaccine group. QIV induced 
      GMTs to each A and B strain that were noninferior to those induced by the 
      2009-2010 and 2008-2009 TIVs (i.e., lower limit of the two-sided 95% confidence 
      interval of the ratio of GMT(QIV)/GMT(TIV)>0.66 for each strain). Rates of 
      seroprotection and seroconversion were similar in all groups. Incidence and 
      severity of solicited injection-site and systemic reactions, AEs, and SAEs were 
      similar among groups. CONCLUSION: QIV, containing two B strains (one from each B 
      lineage), was as safe and immunogenic as licensed TIV. QIV has the potential to 
      be a useful alternative to TIV and offer protection against both B lineages.
CI  - Copyright (c) 2012 Elsevier Ltd. All rights reserved.
FAU - Greenberg, David P
AU  - Greenberg DP
AD  - Sanofi Pasteur, Swiftwater, PA 18370, USA. David.Greenberg@sanofipasteur.com
FAU - Robertson, Corwin A
AU  - Robertson CA
FAU - Noss, Michael J
AU  - Noss MJ
FAU - Blatter, Mark M
AU  - Blatter MM
FAU - Biedenbender, Rex
AU  - Biedenbender R
FAU - Decker, Michael D
AU  - Decker MD
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20121208
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  - 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  - Serum/immunology
MH  - United States
MH  - Vaccines, Inactivated/administration & dosage/adverse effects/immunology
MH  - Young Adult
EDAT- 2012/12/12 06:00
MHDA- 2013/07/03 06:00
CRDT- 2012/12/12 06:00
PHST- 2012/06/25 00:00 [received]
PHST- 2012/11/27 00:00 [accepted]
PHST- 2012/12/12 06:00 [entrez]
PHST- 2012/12/12 06:00 [pubmed]
PHST- 2013/07/03 06:00 [medline]
AID - S0264-410X(12)01724-0 [pii]
AID - 10.1016/j.vaccine.2012.11.074 [doi]
PST - ppublish
SO  - Vaccine. 2013 Jan 21;31(5):770-6. doi: 10.1016/j.vaccine.2012.11.074. Epub 2012 
      Dec 8.