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

Roberton, D, Marshall, H, Nolan, T, Sokal, E, Diez-Domingo, J, Flodmark, C, Rombo, L, Lewald, G, de la Flor, J, Casanovas, J, Verdaguer, J, Mares, J, Van Esso, D, Dieussaert, I, Stoffel, M
This study was conducted to compare the reactogenicity, immunogenicity and safety of a combined two-dose (0, 6 months) hepatitis A and B vaccine (720 EL U HAV, 20 mcg HBsAg) with the established three-dose (0, 1 and 6 months) hepatitis A and B vaccine (360 EL U 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, I month after the end of the vaccination course (Month 7). (c) 2005 Elsevier Ltd. All rights reserved.
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