Virosomal influenza vaccine: a safe and effective influenza vaccine with high efficacy in elderly and subjects with low pre-vaccination antibody titers
Virosomal influenza vaccine: a safe and effective influenza vaccine with high efficacy in elderly and subjects with low pre-vaccination antibody titers
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DOI：
10.1016/j.virusres.2004.02.026
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发表时间：
2004-07-01
期刊：
影响因子：
5
通讯作者：
Palache, AM
中科院分区：
文献类型：
--
作者：
de Bruijn, IA;Nauta, J;Palache, AM
在14项临床研究中，在2865名受试者中评估了新型病毒体流感疫苗（Invivac（R））的各种有效性和安全性。病毒体流感疫苗完全符合专利药品委员会（CPMP）对流感疫苗免疫原性的要求。特别是，在接种前滴度较低的受试者亚组（即实际需要疫苗保护的受试者）中，76%至99%的受试者（取决于年龄、健康状况和疫苗组分）在接种病毒体流感疫苗后达到了保护性血凝抑制（HI）抗体滴度。在临床研究和上市后研究人群中，在健康成人和风险受试者中观察到已知局部和全身反应的可接受频率。这些反应是一过性的，通常不严重，不会造成重大不便。总之，Invivac（R）是一种有效和安全的疫苗，可保护健康和慢性病成人受试者免受流感感染。该疫苗在接种前免疫力低的受试者中特别有效。(C)2004 Elsevier B.V.保留所有权利。
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.