Immunogenicity, reactogenicity and safety of two-dose versus three-dose (standard care) hepatitis B immunisation of healthy adolescents aged 11-15 years: a randomised controlled trial.
This trial assessed the immunogenicity, safety and reactogenicity of a two-dose hepatitis B immunisation regimen (thiomersal-free Engerix-B 20 microg HBsAg doses 6 months apart) compared to the standard three-dose vaccination regimen (preservative-free Engerix-B 10 microg HBsAg doses, 0, 1, 6 month dose schedule) in healthy adolescents aged 11-15 years. Subjects were randomly assigned (2:1 ratio) to one of the two regimens (258 to the two-dose [20 microg] and 126 to the three-dose [10 microg] regimen) (Study ID 103860/280). One month after the final vaccine dose, the seroprotection (anti-HBs >or=10mIU/ml) rate in the two-dose (20 microg) group (233/241 individuals -96.7% seroprotected) was non-inferior to the seroprotection rate in the three-dose (10 microg) group (111/113 individuals -98.2% seroprotected). Both regimens were shown to be safe and well tolerated. Two doses of Engerix-B (20 microg HBsAg) could be considered as an alternative to standard three-dose Engerix-B (10 microg HBsAg) immunisation for adolescents aged 11-15 years.
Heron
Leon
L
National Center for Immunisation Research and Surveillance of Vaccine Preventable Diseases, Childrens Hospital, Westmead, Australia.
Selnikova
Olga
O
Moiseieva
Anna
A
Van Damme
Pierre
P
van der Wielen
Marie
M
Levie
Karin
K
Hoet
Bernard
B
Stoffel
Michel
M
D000293:Adolescent; D002648:Child; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D006801:Humans; D007115:Immunization Schedule; D016037:Single-Blind Method; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
C075654:Engerix-B; D017325:Hepatitis B Vaccines; D014614:Vaccines, Synthetic