title: Immunogenicity and safety of an inactivated quadrivalent influenza vaccine candidate: a phase III randomized controlled trial in children.
abstract: BACKGROUND
  Mismatch between circulating influenza B viruses (Yamagata and Victoria lineages) and vaccine strains occurs frequently.
  
  
  METHODS
  In a randomized controlled trial, immunogenicity and safety of an inactivated quadrivalent influenza vaccine candidate (QIV) versus trivalent inactivated influenza vaccine (TIV)-Victoria(Vic) and TIV-Yamagata(Yam) in children 3-17 years of age was evaluated. In an open-label study arm, QIV only was assessed in children 6-35 months of age.
  
  
  RESULTS
  A total of 3094 children (932 QIV, 929 TIV-Vic, 932 TIV-Yam, and 301 QIV only) were vaccinated. QIV was noninferior to the TIVs for shared strains (A/H3N2 and A/H1N1) based on hemagglutination-inhibition (HI) antibodies 28 days after last vaccination, and superior for the unique B strains Victoria and Yamagata (geometric mean titer ratios 2.61, 3.78; seroconversion rate differences 33.96%, 44.63%). Among children in the randomized trial, adverse event rates were similar except for injection site pain (dose 1: 65.4% QIV, 54.6% TIV-Vic, 55.7% TIV-Yam).
  
  
  CONCLUSIONS
  QIV elicited superior HI responses to the added B strains compared to TIV controls, potentially improving its effectiveness against influenza B. HI responses were similar between QIV and TIV controls for the shared strains. QIV had an acceptable safety profile relative to TIVs.
  
  
  BACKGROUND
  NCT01198756.
authors.affiliation: Canadian Center for Vaccinology, Dalhousie University and the IWK Health Centre, Halifax, Nova Scotia, Canada.
authors.forename: Joanne M
authors.initials: JM
authors.lastname: Langley
authors.forename: Alfonso
authors.initials: A
authors.lastname: Carmona Martinez
authors.forename: Archana
authors.initials: A
authors.lastname: Chatterjee
authors.forename: Scott A
authors.initials: SA
authors.lastname: Halperin
authors.forename: Shelly
authors.initials: S
authors.lastname: McNeil
authors.forename: Keith S
authors.initials: KS
authors.lastname: Reisinger
authors.forename: Naresh
authors.initials: N
authors.lastname: Aggarwal
authors.forename: Li-Min
authors.initials: LM
authors.lastname: Huang
authors.forename: Ching-Tien
authors.initials: CT
authors.lastname: Peng
authors.forename: José
authors.initials: J
authors.lastname: Garcia-Sicilia
authors.forename: Ignacio
authors.initials: I
authors.lastname: Salamanca de la Cueva
authors.forename: Fernando
authors.initials: F
authors.lastname: Cabañas
authors.forename: Consuelo
authors.initials: C
authors.lastname: Treviño-Garza
authors.forename: Miguel Angel
authors.initials: MA
authors.lastname: Rodríguez-Weber
authors.forename: Manuel
authors.initials: M
authors.lastname: de la O
authors.forename: Vijayalakshmi
authors.initials: V
authors.lastname: Chandrasekaran
authors.forename: Walthère
authors.initials: W
authors.lastname: Dewé
authors.forename: Aixue
authors.initials: A
authors.lastname: Liu
authors.forename: Bruce L
authors.initials: BL
authors.lastname: Innis
authors.forename: Varsha K
authors.initials: VK
authors.lastname: Jain
mesh_terms: D000293:Adolescent; D000914:Antibodies, Viral / Q000097:blood; D002648:Child; D002675:Child, Preschool; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D007223:Infant; D009980:Influenza A virus / Q000276:immunology; D009981:Influenza B virus / Q000276:immunology; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D008297:Male; D010146:Pain / Q000453:epidemiology / Q000473:pathology; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D014739:Victoria
chemical_list: D000914:Antibodies, Viral; D007252:Influenza Vaccines; D015164:Vaccines, Inactivated
keywords: children; immunogenicity; influenza vaccine