title: [The study on the 0, 12 month vaccination schedule' of Healive inactivated hepatitis A vaccine in children].
abstract: OBJECTIVE
  To evaluate the safety, immunogenicity and fit dosage of Healive inactivated hepatitis A vaccine (HAV) in children.
  
  
  METHODS
  A total of 85 susceptible aged 4 - 10 years with HAV seronegative children, had been enrolled from two adjacent villages in a county. The volunteers were randomized allocated into two groups and to receive a priming dose of 250 U/0.5 ml/dose or 500 U/1.0 ml/dose of Healive vaccine, produced by Sinovac Biotech Co, Ltd. A booster of the same dose was given at 12th month. Local and systemic side effects were examined and seroconversion rate as well as geometric mean titers of anti-HAV antibody were tested at 3-week, 12-month after the primary dose and at 1 month after the booster dose.
  
  
  RESULTS
  The vaccine was well tolerated in both groups. At 21 days after the primary dose, the seroconversion rates were 94.4%, 100.0% and geometric mean titers (GMT) were 195 mIU/ml and 370 mIU/ml in 250 U and 500 U groups respectively. At 12 months after the primary dose, the seroconversion rate of anti-HAV was 100.0%, and GMT raised to 361 mIU/ml, 456 mIU/ml (P > 0.05) respectively. One month after the booster dose, GMT raised to 14 893 mIU/ml, 21 696 mIU/ml.
  
  
  CONCLUSIONS
  GMT of the 0, 12 month schedule was higher than other schedule after the booster vaccination. The Healive inactivated vaccine can be used for emergency vaccination. The Healive inactivated vaccine produced by Sinovac Company Ltd was safe and highly immunogenic. Two hundred and fifty U/dose was considered appropriate for children.
authors.affiliation: Health and Anti-eqidemic Station of Pingshan County, Pingshan 050400, China.
authors.forename: Yin-hai
authors.initials: YH
authors.lastname: Ren
authors.forename: Jiang-ting
authors.initials: JT
authors.lastname: Chen
authors.forename: Wen-ting
authors.initials: WT
authors.lastname: Wu
authors.forename: Xue-jie
authors.initials: XJ
authors.lastname: Gong
authors.forename: Yu-cheng
authors.initials: YC
authors.lastname: Zhang
authors.forename: Wei-hua
authors.initials: WH
authors.lastname: Xue
authors.forename: Yi-feng
authors.initials: YF
authors.lastname: Ren
authors.forename: Lian-jun
authors.initials: LJ
authors.lastname: Han
authors.forename: Wen-xue
authors.initials: WX
authors.lastname: Kang
authors.forename: Sheng-ping
authors.initials: SP
authors.lastname: Li
authors.forename: Chong-bai
authors.initials: CB
authors.lastname: Liu
mesh_terms: D002648:Child; D002675:Child, Preschool; D004306:Dose-Response Relationship, Immunologic; D004334:Drug Administration Schedule; D006506:Hepatitis A / Q000276:immunology / Q000517:prevention & control; D035922:Hepatitis A Antibodies / Q000032:analysis*; D022362:Hepatitis A Vaccines / Q000008:administration & dosage / Q000276:immunology*; D006801:Humans; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000276:immunology*
chemical_list: D035922:Hepatitis A Antibodies; D022362:Hepatitis A Vaccines; D015164:Vaccines, Inactivated