title: Immunogenicity and safety of an inactivated hepatitis A vaccine when coadministered with Diphtheria-tetanus-acellular pertussis and haemophilus influenzae type B vaccines in children 15 months of age.
abstract: BACKGROUND
  This study (NCT00197236) evaluated the safety and immunogenicity of a hepatitis A virus (HAV) vaccine when coadministered with diphtheria-tetanus-acellular pertussis (DTaP) and Haemophilus influenzae type b (Hib) vaccines in children 15 months of age.
  
  
  METHODS
  This was an open-labeled, multicenter study with healthy subjects enrolled and randomized (1:1:1) into 3 treatment groups. A total of 394 subjects received the first study vaccinations at 15 months of age. Group HAV (N = 135) received 2 doses of HAV vaccine 6 to 9 months apart. Group HAV+DTaP+Hib (N = 127) received HAV vaccine coadministered with DTaP and Hib vaccines and the second dose of HAV vaccine, 6 to 9 months later. Group DTaP+Hib→HAV (N = 132) received the DTaP and Hib vaccines at 15 months of age, followed by HAV vaccine 30 days later and the second dose of HAV vaccine 7 to 10 months after the DTaP+Hib vaccines. Immune responses were evaluated before the first study vaccination and 30 days after each vaccine dose. Solicited, unsolicited, and serious adverse events were collected.
  
  
  RESULTS
  After 2 doses of the HAV vaccine, all subjects in the 3 groups were seropositive. The geometric mean concentration of anti-HAV antibodies ranged between 1625.1 and 1904.4 mIU/mL. Coadministration of the 3 vaccines did not impact immunogenicity of the HAV, DTaP, or Hib vaccines. Vaccines were well tolerated in all groups.
  
  
  CONCLUSIONS
  A 2-dose schedule of HAV vaccine was well tolerated and immunogenic when administered to children starting at 15 months of age. Immune responses to the DTaP or Hib vaccines were similar whether they were administered alone or were coadministered with the HAV vaccine.
authors.affiliation: GlaxoSmithKline, King of Prussia, PA, USA. Andrew.F.Trofa@gsk.com
authors.forename: Andrew F
authors.initials: AF
authors.lastname: Trofa
authors.forename: Nicola P
authors.initials: NP
authors.lastname: Klein
authors.forename: Ian M
authors.initials: IM
authors.lastname: Paul
authors.forename: Marian G
authors.initials: MG
authors.lastname: Michaels
authors.forename: Mary
authors.initials: M
authors.lastname: Goessler
authors.forename: Vijayalakshmi
authors.initials: V
authors.lastname: Chandrasekaran
authors.forename: Mark
authors.initials: M
authors.lastname: Blatter
mesh_terms: D000907:Antibodies, Bacterial / Q000276:immunology; D016667:Bacterial Capsules / Q000008:administration & dosage / Q000276:immunology*; D004165:Diphtheria / Q000276:immunology / Q000517:prevention & control; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000008:administration & dosage / Q000276:immunology*; D005260:Female; D006192:Haemophilus Infections / Q000276:immunology / Q000517:prevention & control; D018073:Haemophilus Vaccines / Q000008:administration & dosage / Q000276:immunology*; D006506:Hepatitis A / Q000276:immunology / Q000517:prevention & control; D035922:Hepatitis A Antibodies / Q000276:immunology; D022362:Hepatitis A Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D006801:Humans; D007223:Infant; D008297:Male; D013742:Tetanus / Q000276:immunology / Q000517:prevention & control; D014611:Vaccination; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D018073:Haemophilus Vaccines; C044237:Haemophilus influenzae type b polysaccharide vaccine; D035922:Hepatitis A Antibodies; D022362:Hepatitis A Vaccines; D015164:Vaccines, Inactivated