Reactogenicity and immunogenicity profile of a two-dose combined hepatitis A and B vaccine in 1-11-year-old children.
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).
Roberton
D
D
Department of Paediatrics, Children, Youth and Women's Health Service, North Adelaide SA 5006, Australia. don.roberton@adelaide.edu.au
Marshall
H
H
Nolan
T M
TM
Sokal
E
E
Díez-Domingo
J
J
Flodmark
C-E
CE
Rombo
L
L
Lewald
G
G
Flor
J de la
Jde L
Casanovas
J M
JM
Verdaguer
J
J
Marés
J
J
Esso
D Van
DV
Dieussaert
I
I
Stoffel
M
M
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
D022362:Hepatitis A Vaccines; D017325:Hepatitis B Vaccines; D017778:Vaccines, Combined