Reactogenicity and immunogenicity profile of a two-dose combined hepatitis A and B vaccine in 1-11-year-old children

Vaccine. 2005 Oct 17;23(43):5099-105. doi: 10.1016/j.vaccine.2005.06.003.

Abstract

This study was conducted to compare the reactogenicity, immunogenicity and safety of a combined two-dose (0, 6 months) hepatitis A and B vaccine (720ELU HAV, 20 mcg HBsAg) with the established three-dose (0, 1 and 6 months) hepatitis A and B vaccine (360ELU HAV, 10 mcg HBsAg). A total of 511 children aged 1-11 years who had not previously received a hepatitis A or B vaccine were enrolled in the study. Both vaccines were well tolerated, and were shown to be safe and immunogenic. The analysis, stratified according to two age groups (1-5 year and 6-11-year-old children) demonstrated that the reactogenicity profile of the two-dose schedule was at least as good as that of the established schedule. Both vaccines and schedules provided at least 98% seroprotection against hepatitis B and 100% seroconversion against hepatitis A, 1 month after the end of the vaccination course (Month 7).

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Child
  • Child, Preschool
  • Drug Administration Schedule
  • Hepatitis A / immunology
  • Hepatitis A / prevention & control*
  • Hepatitis A Vaccines / administration & dosage*
  • Hepatitis A Vaccines / adverse effects
  • Hepatitis B / immunology
  • Hepatitis B / prevention & control*
  • Hepatitis B Vaccines / administration & dosage*
  • Hepatitis B Vaccines / adverse effects
  • Humans
  • Immunization Schedule
  • Infant
  • Vaccines, Combined*

Substances

  • Hepatitis A Vaccines
  • Hepatitis B Vaccines
  • Vaccines, Combined