Journal
VIRUS RESEARCH
Volume 103, Issue 1-2, Pages 139-145Publisher
ELSEVIER SCIENCE BV
DOI: 10.1016/j.virusres.2004.02.026
Keywords
influenza vaccine; virosomes; efficacy; safety; reactogenicity
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In 14 clinical studies, various efficacy and safety aspects of a new virosomal influenza vaccine (Invivac(R)) were assessed in 2865 subjects. The virosomal influenza vaccine fully complies with the Committee for Proprietary Medicinal Products (CPMP) requirement for immunogenicity of influenza vaccines. In particular, in a subset of subjects with low pre-vaccination titers (thus those persons who actually need protection by a vaccine), between 76 and 99% of subjects (dependent on age, health status and vaccine components) achieved protective hemagglutination inhibiting (HI) antibody titers after vaccination with the virosomal influenza vaccine. Acceptable frequencies of well-known local and systemic reactions were observed in healthy adults and risk subjects in clinical studies and in a post-marketing study population. These reactions were transient and generally not severe, and did not cause major inconvenience. In conclusion, Invivac(R) is an efficacious and safe vaccine for the protection against influenza in healthy and chronically ill adult subjects. The vaccine is especially efficacious in subjects with low pre-vaccination immunity. (C) 2004 Elsevier B.V. All rights reserved.
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