title: Immunogenicity and safety of an inactivated hepatitis A vaccine administered concomitantly with diphtheria-tetanus-acellular pertussis and haemophilus influenzae type B vaccines to children less than 2 years of age.
abstract: OBJECTIVE
  The availability of a hepatitis A virus vaccine for infant and early childhood immunization could reduce the transmission of hepatitis A virus in the United States. This study evaluated the immunogenicity and safety of a hepatitis A virus vaccine (Havrix, GlaxoSmithKline Biologicals, Rixensart, Belgium) administered concomitantly with diphtheria-tetanus-acellular pertussis and Haemophilus influenzae type b vaccines to children < 2 years.
  
  
  METHODS
  In this open, comparative, multicenter study, 1084 healthy children aged 11 to 25 months were allocated (4:4:3:3:4 ratio) to 5 treatment groups based on age and previous vaccination history. Subjects 11 to 13 months of age received 2 doses of hepatitis A virus vaccine 6 months apart (N = 243). Subjects aged 15 to 18 months received 2 doses of hepatitis A virus vaccine 6 months apart (N = 241); or hepatitis A virus vaccine, diphtheria-tetanus-acellular pertussis, and H influenzae type b at month 0 and the second dose of hepatitis A virus vaccine 6 months later (N = 183); or diphtheria-tetanus-acellular pertussis and H influenzae type b at month 0 and hepatitis A virus vaccine at months 1 and 7 (N = 175). Subjects 23 to 25 months of age received hepatitis A virus vaccine at months 0 and 6 (N = 242). Immune responses were measured at baseline and 30 days after vaccine doses, and solicited and unsolicited adverse events were collected.
  
  
  RESULTS
  After 2 doses of hepatitis A virus vaccine, all of the subjects in all of the groups were seropositive. Coadministration of hepatitis A virus vaccine with diphtheria-tetanus-acellular pertussis and H influenzae type b vaccines did not impact the immunogenicity of the 3 vaccines, except for the antipertussis toxoid vaccine response, which was slightly decreased. Hepatitis A virus vaccine was well tolerated in children 11 to 25 months of age.
  
  
  CONCLUSIONS
  The administration of 2 doses of hepatitis A virus vaccine on a 0- and 6-month schedule starting at 11 to 13 months of age or at 15 to 18 months of age was as immunogenic and well tolerated as the administration of 2 doses in children 2 years of age. Immune responses to diphtheria-tetanus-acellular pertussis and H influenzae type b either given alone or coadministered with hepatitis A virus vaccine were similar except for antipertussis toxoid response.
authors.affiliation: School of Population Health, University of Melbourne, Victoria 3010, Australia. t.nolan@unimelb.edu.au
authors.forename: Terry
authors.initials: T
authors.lastname: Nolan
authors.forename: Henry
authors.initials: H
authors.lastname: Bernstein
authors.forename: Mark M
authors.initials: MM
authors.lastname: Blatter
authors.forename: Kenneth
authors.initials: K
authors.lastname: Bromberg
authors.forename: Fernando
authors.initials: F
authors.lastname: Guerra
authors.forename: William
authors.initials: W
authors.lastname: Kennedy
authors.forename: Michael
authors.initials: M
authors.lastname: Pichichero
authors.forename: Shelly D
authors.initials: SD
authors.lastname: Senders
authors.forename: Andrew
authors.initials: A
authors.lastname: Trofa
authors.forename: Alix
authors.initials: A
authors.lastname: Collard
authors.forename: Diane C
authors.initials: DC
authors.lastname: Sullivan
authors.forename: Dominique
authors.initials: D
authors.lastname: Descamps
mesh_terms: D000917:Antibody Formation; D002675:Child, Preschool; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D005260:Female; D018073:Haemophilus Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D006506:Hepatitis A / Q000517:prevention & control / Q000635:transmission; D022362:Hepatitis A Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D008297:Male; D015164:Vaccines, Inactivated
chemical_list: D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; D022362:Hepatitis A Vaccines; D015164:Vaccines, Inactivated; C080881:diphtheria-tetanus-pertussis-haemophilus b conjugate vaccine