Safety and immunogenicity of a trivalent, inactivated, mammalian cell culture-derived influenza vaccine in healthy adults, seniors, and children

被引:74
作者
Halperin, SA
Smith, B
Mabrouk, T
Germain, M
Trépanier, P
Hassell, T
Treanor, J
Gauthier, R
Mills, EL
机构
[1] Dalhousie Univ, Clin Trials Res Ctr, IWK Hlth Ctr, Dept Pediat, Halifax, NS B3J 3G9, Canada
[2] Dalhousie Univ, Clin Trials Res Ctr, IWK Hlth Ctr, Dept Microbiol & Immunol, Halifax, NS B3J 3G9, Canada
[3] Dalhousie Univ, Dept Math, Halifax, NS B3J 3G9, Canada
[4] Dalhousie Univ, Dept Stat, Halifax, NS B3J 3G9, Canada
[5] BioChem Pharma, Laval, PQ, Canada
[6] Univ Rochester, Dept Med, Rochester, NY USA
[7] Hop Maison Neuve Rosemont, Montreal, PQ H1T 2M4, Canada
[8] McGill Univ, Laval, PQ, Canada
关键词
influenza vaccine; cell culture; influenza;
D O I
10.1016/S0264-410X(01)00428-5
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
We performed randomized, double-blind, controlled trials to assess the safety and immunogenicity of an inactivated, Madin Darby Canine Kidney (MDCK)-derived cell line produced influenza vaccine in healthy adults (19-50 years), children (3-12 years) and the elderly (greater than or equal to65 years). We studied three lots of cell culture-derived vaccine and one lot of licensed egg-derived vaccine in healthy adults (n = 462), two lots of cell culture-derived vaccine and one lot of egg-derived vaccine in seniors (n = 269), and one lot of each vaccine in children (n = 209). Adverse events were collected during the first 3 days post-immunization; serum was collected before and I month after immunization. Rates of local and system adverse reactions were similar with both vaccines. An injection site adverse event rated at least moderate severity was reported by 21.9% of children who received the egg-derived vaccine and 25.0% of those who received the cell culture-derived vaccine. In healthy adults the proportions were 12.1 and 15.3%, respectively and 6.7 and 6.3%, respectively in seniors. Systemic events of at least moderate severity were 12.4 and 12.5% in children, 19.8 and 13.6% in healthy adults, and 14.1 and 9.7% in seniors; none of these differences were statistically significant. The antibody response against all three viruses was similar between the two vaccines. From 83 to 100% of children, healthy adults and seniors achieved hemagglutination inhibition titers in excess of 40 post-immunization. We conclude that the cell culture-derived vaccine was safe and immunogenic in children, healthy adults and seniors. (C) 2002 Elsevier Science Ltd. All rights reserved.
引用
收藏
页码:1240 / 1247
页数:8
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