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Safety and immunogenicity profile of an experimental hepatitis B vaccine adjuvanted with AS04


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 (2004). Safety and immunogenicity profile of an experimental hepatitis B vaccine adjuvanted with AS04. Vaccine, 23(3):316-320.

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.

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.

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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > Epidemiology, Biostatistics and Prevention Institute (EBPI)
Dewey Decimal Classification:610 Medicine & health
Language:English
Date:2004
Deposited On:16 Jun 2009 15:00
Last Modified:06 Dec 2017 20:01
Publisher:Elsevier
ISSN:0264-410X
Publisher DOI:https://doi.org/10.1016/j.vaccine.2004.06.006
PubMed ID:15530674

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