title: Safety and immunogenicity profiles of an adjuvanted seasonal influenza vaccine in Guatemalan children.
abstract: BACKGROUND
  The efficacy of non-adjuvanted seasonal influenza vaccine in young children is considered to be suboptimal. This study compared the safety and immunogenicity profiles of MF59-adjuvanted, trivalent, influenza vaccine (ATIV) and non-adjuvanted, trivalent, influenza vaccine (TIV) in Guatemalan children (N = 360) between 6 and < 60 months of age.
  
  
  METHODS
  Children received two doses of ATIV or TIV administered four weeks apart. Solicited adverse reactions were recorded for seven days after each vaccination. Serious adverse events were recorded throughout the entire study period. Antibody responses were assessed by hemagglutination inhibition (HI) assay at baseline, four weeks after administration of the first vaccine dose, and three weeks after administration of the second dose.
  
  
  RESULTS
  Both ATIV and TIV were well tolerated, with similar rates of solicited reactions and adverse events observed in response to both vaccines. MF59-adjuvanted vaccine induced considerably higher antibody titers than did TIV. After two doses, the B strain-specific antibody response to TIV was insufficient to meet the Center for Biologics Evaluation and Research (CBER) licensure criterion for seroprotection, whereas responses to the MF59-adjuvanted vaccine met the seroprotection criterion against all three strains. Cross-reactive antibody responses to MF59-adjuvanted vaccine met the CBER seroprotection criterion against all three strains after two doses; B strain-specific heterologous responses to non-adjuvanted TIV were inadequate.
  
  
  CONCLUSIONS
  The MF59-adjuvanted seasonal influenza vaccine was well-tolerated and highly immunogenic in children 6 to < 60 months of age, inducing seroprotective antibody titers against both the vaccine strains and antigenically distinct heterologous strains.
authors.affiliation: Hospital Infantil de Infectologia y Rehabilitacion, Ciudad de Guatemala, Guatemala. adib.rodriguez@gmail.com.
authors.forename: Adib Rodriguez
authors.initials: AR
authors.lastname: Solares
authors.forename: Carlos Grazioso
authors.initials: CG
authors.lastname: Aragon
authors.forename: Rodolfo Urruela
authors.initials: RU
authors.lastname: Pivaral
authors.forename: David
authors.initials: D
authors.lastname: Prado-Cohrs
authors.forename: Victor
authors.initials: V
authors.lastname: Sales-Carmona
authors.forename: Michele
authors.initials: M
authors.lastname: Pellegrini
authors.forename: Nicola
authors.initials: N
authors.lastname: Groth
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage* / Q000009:adverse effects*; D000914:Antibodies, Viral / Q000097:blood; D002675:Child, Preschool; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D006166:Guatemala; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D007223:Infant; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D007251:Influenza, Human / Q000517:prevention & control*; D008297:Male; D011136:Polysorbates / Q000008:administration & dosage / Q000009:adverse effects; D013185:Squalene / Q000008:administration & dosage / Q000009:adverse effects; D014611:Vaccination / Q000379:methods
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D007252:Influenza Vaccines; C089950:MF59 oil emulsion; D011136:Polysorbates; D013185:Squalene