title: An open, prospective, randomized study comparing the immunogenicity and safety of two inactivated hepatitis A pediatric vaccines in toddlers, children and adolescents in China.
abstract: BACKGROUND
  Vaccines against hepatitis A provide long-lasting protection in both adults and children. The aim of this study was to demonstrate that the inactivated hepatitis A vaccine AVAXIM 80U Pediatric is safe and not inferior in terms of seroprotection rate to HAVRIX 720 vaccine 1 month after booster vaccination.
  
  
  METHODS
  An open, randomized, single-center trial was conducted in China in healthy antihepatitis A virus seronegative individuals from 12 months to 15 years of age. Participants were randomized in a 2:1 ratio to receive either AVAXIM 80U Pediatric or HAVRIX 720, followed by a booster vaccination, using the same vaccine 6 months afterward.
  
  
  RESULTS
  A total of 720 individuals were included in the study, 480 in the AVAXIM 80U Pediatric group and 240 in the HAVRIX 720 group, and 686 individuals completed the full vaccination schedule. AVAXIM 80U Pediatric was statistically noninferior to HAVRIX 720 in terms of seroprotection rate for all individuals and in each of 3 age groups: toddlers (12-23 months), children (2-11 years) and adolescents (12-15 years). Antihepatitis A virus geometric mean titers were significantly higher with AVAXIM 80U Pediatric than with HAVRIX 720. Both inactivated hepatitis A vaccines were well-tolerated and had a similar incidence and type of adverse events.
  
  
  CONCLUSIONS
  AVAXIM 80U Pediatric is safe and immunogenic, with a seroprotection rate that is not inferior to HAVRIX 720 in a pediatric population of healthy individuals.
authors: Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control, Center for Vaccine Clinical Trials, Nanning Guangxi, China.
authors: Rong Cheng
authors: RC
authors: Li
authors: Yanping
authors: Y
authors: Li
authors: Nong
authors: N
authors: Yi
authors: Lirong
authors: L
authors: Huang
authors: Zongju
authors: Z
authors: Wan
authors: Yanping
authors: Y
authors: Zhang
authors: Anvar
authors: A
authors: Rasuli
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D002681:China; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; 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; D007115:Immunization Schedule; D007117:Immunization, Secondary; D007223:Infant; D008297:Male; D011446:Prospective Studies; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D035922:Hepatitis A Antibodies; D022362:Hepatitis A Vaccines; D015164:Vaccines, Inactivated