title: Heterologous prime-boost vaccination using an AS03B-adjuvanted influenza A(H5N1) vaccine in infants and children<3 years of age.
abstract: BACKGROUND
  Protecting young children from pandemic influenza should also reduce transmission to susceptible adults, including pregnant women.
  
  
  METHODS
  An open study assessed immunogenicity and reactogenicity of a heterologous booster dose of A/turkey/Turkey/1/2005(H5N1)-AS03B (AS03B is an Adjuvant System containing α-tocopherol and squalene in an oil-in-water emulsion [5.93 mg tocopherol]) in infants and children aged 6 to <36 months that was given 6 months following 2-dose primary vaccination with A/Indonesia/05/2005(H5N1)-AS03B. Vaccines contained 1.9 µg of hemagglutinin antigen and AS03B. Hemagglutinin inhibition (HI) responses, microneutralization titers, and antineuraminidase antibody levels were assessed for 6 months following the booster vaccination.
  
  
  RESULTS
  For each age stratum (defined on the basis of the subject's age at first vaccination as 6 to <12 months, 12 to <24 months, and 24 to <36 months) and overall (n=113), European influenza vaccine licensure criteria were fulfilled for responses to A/turkey/Turkey/1/2005(H5N1) 10 days following the booster vaccination. Local pain and fever increased with consecutive doses. Anamnestic immune responses were demonstrated for HI, neutralizing, and antineuraminidase antibodies against vaccine-homologous/heterologous strains. Antibody responses to vaccine-homologous/heterologous strains persisted in all children 6 months following the booster vaccination.
  
  
  CONCLUSIONS
  Prevaccination of young children with a clade 2 strain influenza A(H5N1) AS03-adjuvanted vaccine followed by heterologous booster vaccination boosted immune responses to the homologous strain and a related clade, with persistence for at least 6 months. The results support a prime-boost vaccination approach in young children for pandemic influenza preparedness.
  
  
  BACKGROUND
  NCT01323946.
authors: Murdoch Childrens Research Institute Melbourne School of Population and Global Health, University of Melbourne, Victoria.
authors: Terry
authors: T
authors: Nolan
authors: GlaxoSmithKline Vaccines, Wavre.
authors: Patricia
authors: P
authors: Izurieta
authors: Mount Elizabeth Medical Centre.
authors: Bee-Wah
authors: BW
authors: Lee
authors: National University Hospital, Singapore.
authors: Poh Chong
authors: PC
authors: Chan
authors: Vaccinology and Immunology Research Trials Unit, Women's and Children's Hospital, North Adelaide School of Paediatrics and Reproductive Health Robinson Research Institute, University of Adelaide.
authors: Helen
authors: H
authors: Marshall
authors: Children's Hospital at Westmead, National Centre for Immunisation Research and Surveillance, Australia.
authors: Robert
authors: R
authors: Booy
authors: GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
authors: Mamadou
authors: M
authors: Drame
authors: GlaxoSmithKline Vaccines, Rixensart, Belgium.
authors: David W
authors: DW
authors: Vaughn
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage*; D000914:Antibodies, Viral / Q000276:immunology; D002675:Child, Preschool; D005260:Female; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D007117:Immunization, Secondary; D007223:Infant; D053124:Influenza A Virus, H5N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D007251:Influenza, Human / Q000517:prevention & control*; D008297:Male; D012846:Singapore / Q000453:epidemiology; D014611:Vaccination
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D007252:Influenza Vaccines
keywords: H5N1; booster; children; influenza; pandemic