Safety and immunogenicity profile of an experimental hepatitis B vaccine adjuvanted with AS04
Details
Serval ID
serval:BIB_23466EBDFE27
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Safety and immunogenicity profile of an experimental hepatitis B vaccine adjuvanted with AS04
Journal
Vaccine
ISSN
0264-410X (Print)
Publication state
Published
Issued date
12/2004
Volume
23
Number
3
Pages
316-20
Notes
Clinical Trial
Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial --- Old month value: Dec 2
Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial --- Old month value: Dec 2
Abstract
The reactogenicity and safety of an experimental hepatitis B (HB) vaccine containing adjuvant system (AS04) was compared with a licensed vaccine in a phase III, single-blind, randomised study in healthy volunteers >or=15 years of age. A total of 1303 subjects were enrolled to receive either two doses of HB-AS04 (0, 6 months) or three doses of the comparator vaccine (0, 1, 6 months). Two doses of HB-AS04 elicited seroprotection rates close to 100% and two-fold higher GMTs than the comparator vaccine. Results showed that both vaccines were well tolerated and the general safety profile of HB-AS04 was similar to that of the comparator vaccine.
Keywords
Adjuvants, Immunologic/*adverse effects
Adolescent
Adult
Aged
Female
Hepatitis B/immunology
Hepatitis B Antibodies/biosynthesis/blood
Hepatitis B Vaccines/*adverse effects/*immunology
Humans
Male
Middle Aged
Prospective Studies
Radioimmunoassay
Single-Blind Method
Pubmed
Web of science
Create date
28/01/2008 12:49
Last modification date
20/08/2019 14:00