Safety, tolerability and immunogenicity of a mammalian cell-culture-derived influenza vaccine: A sequential Phase I and Phase II clinical trial

被引:37
作者
Groth, N. [1 ]
Montomoli, E. [2 ]
Gentile, C. [2 ]
Manini, I. [2 ]
Bugarini, R. [1 ]
Podda, A. [1 ]
机构
[1] Novartis Vaccines Global Clin Res & Dev, I-53100 Siena, Italy
[2] Univ Siena, Lab Mol Epidemiol, Dept Physiopatol Expt Med & Publ Hlth, I-53100 Siena, Italy
关键词
Influenza; Cell-culture; Vaccine; VIRUS; HEMAGGLUTININ; EPIDEMIOLOGY; MORTALITY; ANTIBODY; IMPACT;
D O I
10.1016/j.vaccine.2008.11.003
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
This sequential, observer-blind, randomised, single-centre, combined Phase I and Phase II clinical trial compared the tolerability and immunogenicity of a single intramuscular dose of a novel cell-culture-derived influenza vaccine (CCIV), produced in Madin-Darby canine kidney cells, with a conventional egg-based vaccine. The immunogenicity of both vaccines was assessed by SRH assay, a well-recognized test by EMEA, in compliance with the requirements of the EU Committee for Medicinal Products for Human Use(CHMP). The Phase I part of the trial comprised 40 healthy adults (18-40 years of age); the subsequent Phase II part involved 200 healthy adult (n = 80, 18-60 years of age)and elderly(n = 120, >= 61 years of age) subjects. Both vaccines showed similar reactogenicity and any solicited local or systemic reactions were mostly mild or moderate. Regarding immunogenicity, both the CCIV and the control vaccine met all of the EU Committee for Medicinal Products for Human Use criteria for influenza vaccines for each strain and in both age groups. In conclusion, the CCIV produced in mammalian cell-culture is as well tolerated and as immunogenic as the control egg-based vaccine in non-elderly and elderly adults. (C) 2008 Elsevier Ltd. All rights reserved.
引用
收藏
页码:786 / 791
页数:6
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