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

Détails

ID Serval
serval:BIB_23466EBDFE27
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
Safety and immunogenicity profile of an experimental hepatitis B vaccine adjuvanted with AS04
Périodique
Vaccine
Auteur⸱e⸱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)
Statut éditorial
Publié
Date de publication
12/2004
Volume
23
Numéro
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
Résumé
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.
Mots-clé
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
Création de la notice
28/01/2008 12:49
Dernière modification de la notice
20/08/2019 14:00
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