title: AS03B-adjuvanted H5N1 influenza vaccine in children 6 months through 17 years of age: a phase 2/3 randomized, placebo-controlled, observer-blinded trial.
abstract: BACKGROUND
  This phase 2/3, randomized, placebo-controlled, observer-blinded study assessed the immunogenicity, reactogenicity, and safety of an inactivated, split-virion H5N1 influenza vaccine (A/Indonesia/5/2005) in children aged 6 months through 17 years.
  
  
  METHODS
  Children received 2 influenza vaccine doses 21 days apart, each containing 1.9 µg of hemagglutinin and AS03B adjuvant (5.93 mg of α-tocopherol). The randomization ratio was 8:3 for vaccine to placebo, with equal allocation between 3 age strata (6-35 months, 3-8 years, and 9-17 years). Immunogenicity against the vaccine strain was assessed 21 days after the first and second vaccine doses for all vaccinees, at day 182 for half, and at day 385 for the remaining half. Reactogenicity after each dose and safety up to 1 year after vaccination were evaluated.
  
  
  RESULTS
  Within each age stratum, the lower limit of the 98.3% confidence interval for the day 42 seroprotection rate was ≥70%, thus fulfilling the US and European licensure criteria. The immune responses elicited by vaccine persisted well above baseline levels for 1 year. The vaccine was more reactogenic than placebo, but no major safety concerns were identified.
  
  
  CONCLUSIONS
  AS03B-adjuvanted H5N1 influenza vaccine was immunogenic and showed an acceptable safety profile in all age groups studied. Clinical Trials Registration: NCT01310413.
authors.affiliation: Department of Pediatrics, Khon Kaen University, Thailand.
authors.forename: Pope
authors.initials: P
authors.lastname: Kosalaraksa
authors.affiliation: Internal Medicine, Benchmark Research, Metairie, Louisiana.
authors.forename: Robert
authors.initials: R
authors.lastname: Jeanfreau
authors.affiliation: QT Research, Sherbrooke, Canada.
authors.forename: Louise
authors.initials: L
authors.lastname: Frenette
authors.affiliation: GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
authors.forename: Mamadou
authors.initials: M
authors.lastname: Drame
authors.affiliation: GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
authors.forename: Miguel
authors.initials: M
authors.lastname: Madariaga
authors.affiliation: GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
authors.forename: Bruce L
authors.initials: BL
authors.lastname: Innis
authors.affiliation: GlaxoSmithKline Vaccines, Wavre.
authors.forename: Olivier
authors.initials: O
authors.lastname: Godeaux
authors.affiliation: GlaxoSmithKline Vaccines, Wavre.
authors.forename: Patricia
authors.initials: P
authors.lastname: Izurieta
authors.affiliation: GlaxoSmithKline Vaccines, Rixensart, Belgium.
authors.forename: David W
authors.initials: DW
authors.lastname: Vaughn
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage*; D000293:Adolescent; D000914:Antibodies, Viral / Q000097:blood; D002648:Child; D002675:Child, Preschool; D004338:Drug Combinations; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D006801:Humans; D007223:Infant; D053124:Influenza A Virus, H5N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D007251:Influenza, Human / Q000276:immunology / Q000517:prevention & control* / Q000821:virology; D008297:Male; D010919:Placebos / Q000008:administration & dosage; D011136:Polysorbates / Q000008:administration & dosage* / Q000009:adverse effects; D016037:Single-Blind Method; D013185:Squalene / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D014611:Vaccination / Q000379:methods; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D024502:alpha-Tocopherol / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D004338:Drug Combinations; D007252:Influenza Vaccines; D010919:Placebos; D011136:Polysorbates; D015164:Vaccines, Inactivated; D013185:Squalene; C550253:AS03 adjuvant; D024502:alpha-Tocopherol
keywords: AS03B; H5N1; Prepandrix™; adjuvant; influenza vaccine; pandemic