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

来源：

VACCINE | 2010年 / 28卷 / 45期

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

页码：7331 / 7336

页数：6

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