Safety of MF59-adjuvanted versus non-adjuvanted influenza vaccines in children and adolescents: An integrated analysis

被引:37
作者
Black, Steven [1 ,2 ]
Della Cioppa, Giovanni [3 ]
Malfroot, Anne [4 ]
Nacci, Pantaleo [3 ]
Nicolay, Uwe [5 ]
Pellegrini, Michele [3 ]
Sokal, Etienne [6 ]
Vertruyen, Andre [7 ]
机构
[1] Cincinnati Childrens Hosp, Ctr Global Hlth, Cincinnati, OH 45326 USA
[2] Cincinnati Childrens Hosp, Div Infect Dis, Cincinnati, OH 45326 USA
[3] Novartis Vaccines & Diagnost, Global Clin Res & Dev, Siena, Italy
[4] Univ Ziekenhuis Brussel, Dept Pediat, Clin Pediat Resp Dis Infect Dis & Travel, Cyst Fibrosis Clin, Brussels, Belgium
[5] Novartis Vaccines & Diagnost, Global Clin Res & Dev, Marburg, Germany
[6] Catholic Univ Louvain, Clin St Luc, B-1200 Brussels, Belgium
[7] Sint Vincentiushosp GZA Grp, Dept Pediat, Antwerp, Belgium
关键词
Influenza vaccine; MF59; adjuvant; Children; Adolescents; HEALTHY-CHILDREN; MF59; ADJUVANT; A H1N1; IMMUNOGENICITY; VACCINATION; SQUALENE;
D O I
10.1016/j.vaccine.2010.08.075
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 reviewed the safety of MF59-adjuvanted versus non-adjuvanted influenza vaccines in children and adolescents (aged 6 months-18 years) in an integrated analysis of all pediatric trials evaluating MF59-containing influenza vaccines completed to date (5 trials). In the MF59-adjuvanted group (n = 1181) versus the non-adjuvanted group (n = 545) there was no increase in the incidence of unsolicited adverse events and serious adverse events. As expected, solicited local or systemic reactions occurred more frequently in MF59-adjuvanted subjects; however, a majority of reactions were mild and transient. These data support the safety of MF59-adjuvanted influenza vaccines in the pediatric population. (C) 2010 Elsevier Ltd. All rights reserved.
引用
收藏
页码:7331 / 7336
页数:6
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