Safety and immunogenicity profile of an experimental hepatitis B vaccine adjuvanted with AS04
(2004) Vaccine — Vol. 23, n° 3, p. 316-320 (2004)
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- 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 greater than or equal to 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. (C) 2004 Elsevier Ltd. All rights reserved.
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Boland, G., Beran, J., Lievens, M., Sasadeusz, J., Dentico, P., Nothdurft, H., Zuckerman, J., 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. https://doi.org/10.1016/j.vaccine.2004.06.006 (Original work published 2004)