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
Author(s)
Boland  G., Beran  J., Lievens  M., Sasadeusz  J., Dentico  P., Nothdurft  H., Zuckerman  J. N., Genton  B., Steffen  R., Loutan  L., Van Hattum  J., Stoffel  M.
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
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 11:49
Last modification date
20/08/2019 13:00
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