title: Reactogenicity and immunogenicity profile of a two-dose combined hepatitis A and B vaccine in 1-11-year-old children.
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).
authors.affiliation: Department of Paediatrics, Children, Youth and Women's Health Service, North Adelaide SA 5006, Australia. don.roberton@adelaide.edu.au
authors.forename: D
authors.initials: D
authors.lastname: Roberton
authors.forename: H
authors.initials: H
authors.lastname: Marshall
authors.forename: T M
authors.initials: TM
authors.lastname: Nolan
authors.forename: E
authors.initials: E
authors.lastname: Sokal
authors.forename: J
authors.initials: J
authors.lastname: Díez-Domingo
authors.forename: C-E
authors.initials: CE
authors.lastname: Flodmark
authors.forename: L
authors.initials: L
authors.lastname: Rombo
authors.forename: G
authors.initials: G
authors.lastname: Lewald
authors.forename: J de la
authors.initials: Jde L
authors.lastname: Flor
authors.forename: J M
authors.initials: JM
authors.lastname: Casanovas
authors.forename: J
authors.initials: J
authors.lastname: Verdaguer
authors.forename: J
authors.initials: J
authors.lastname: Marés
authors.forename: D Van
authors.initials: DV
authors.lastname: Esso
authors.forename: I
authors.initials: I
authors.lastname: Dieussaert
authors.forename: M
authors.initials: M
authors.lastname: Stoffel
mesh_terms: D002648:Child; D002675:Child, Preschool; D004334:Drug Administration Schedule; D006506:Hepatitis A / Q000276:immunology / Q000517:prevention & control*; D022362:Hepatitis A Vaccines / Q000008:administration & dosage* / Q000009:adverse effects; D006509:Hepatitis B / Q000276:immunology / Q000517:prevention & control*; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D017778:Vaccines, Combined
chemical_list: D022362:Hepatitis A Vaccines; D017325:Hepatitis B Vaccines; D017778:Vaccines, Combined