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

Author(s): Roberton D, Marshall H, Nolan TM, Sokal E, Diez-Domingo J, Flodmark CE, Rombo L, Lewald G, Flor Jde L, Casanovas JM, Verdaguer J, Mares J, Esso DV, Dieussaert I, Stoffel M

Affiliation(s): Department of Paediatrics, Children, Youth and Women's Health Service, North Adelaide SA 5006, Australia. don.roberton@adelaide.edu.au

Publication date & source: 2005-10-17, Vaccine., 23(43):5099-105.

Publication type: Multicenter Study; Randomized Controlled Trial

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).

Page last updated: 2006-01-31

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