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

共 25 条

[11] The Global State of Influenza in Children [J].

Esposito, Susanna ;

Marchisio, Paola ;

Principi, Nicola .

PEDIATRIC INFECTIOUS DISEASE JOURNAL, 2008, 27 (11) :S149-S153

[12] The rational use of influenza vaccines in healthy children and children with underlying conditions [J].

Esposito, Susanna ;

Principi, Nicola .

CURRENT OPINION IN INFECTIOUS DISEASES, 2009, 22 (03) :244-249

[13] Adjuvanted H5N1 vaccine induces early CD4+ T cell response that predicts long-term persistence of protective antibody levels [J].

Galli, Grazia ;

Medini, Duccio ;

Borgogni, Erica ;

Zedda, Luisanna ;

Bardelli, Monia ;

Malzone, Carmine ;

Nuti, Sandra ;

Tavarini, Simona ;

Sammicheli, Chiara ;

Hilbert, Anne K. ;

Brauer, Volker ;

Banzhoff, Angelika ;

Rappuoli, Rino ;

Del Giudice, Giuseppe ;

Castellino, Flora .

PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA, 2009, 106 (10) :3877-3882

[14] The arthritogenic adjuvant squalene does not accumulate in joints, but gives rise to pathogenic cells in both draining and non-draining lymph nodes [J].

Holm, BC ;

Svelander, L ;

Bucht, A ;

Lorentzen, JC .

CLINICAL AND EXPERIMENTAL IMMUNOLOGY, 2002, 127 (03) :430-435

[15] Vaccines for preventing influenza in healthy children [J].

Jefferson, T. ;

Rivetti, A. ;

Harnden, A. ;

Di Pietrantonj, C. ;

Demicheli, V .

COCHRANE DATABASE OF SYSTEMATIC REVIEWS, 2008, (02)

[16] Critically Ill Patients With 2009 Influenza A(H1N1) Infection in Canada [J].

Kumar, Anand ;

Zarychanski, Ryan ;

Pinto, Ruxandra ;

Cook, Deborah J. ;

Marshall, John ;

Lacroix, Jacques ;

Stelfox, Tom ;

Bagshaw, Sean ;

Choong, Karen ;

Lamontagne, Francois ;

Turgeon, Alexis F. ;

Lapinsky, Stephen ;

Ahern, Stephane P. ;

Smith, Orla ;

Siddiqui, Faisal ;

Jouvet, Philippe ;

Khwaja, Kosar ;

McIntyre, Lauralyn ;

Menon, Kusum ;

Hutchison, Jamie ;

Hornstein, David ;

Joffe, Ari ;

Lauzier, Francois ;

Singh, Jeffrey ;

Karachi, Tim ;

Wiebe, Kim ;

Olafson, Kendiss ;

Ramsey, Clare ;

Sharma, Sat ;

Dodek, Peter ;

Meade, Maureen ;

Hall, Richard ;

Fowler, Robert A. .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2009, 302 (17) :1872-1879

[17] Pediatric Hospitalizations Associated with 2009 Pandemic Influenza A (H1N1) in Argentina [J].

Libster, Romina ;

Bugna, Jimena ;

Coviello, Silvina ;

Hijano, Diego R. ;

Dunaiewsky, Mariana ;

Reynoso, Natalia ;

Cavalieri, Maria L. ;

Guglielmo, Maria C. ;

Soledad Areso, M. ;

Gilligan, Tomas ;

Santucho, Fernanda ;

Cabral, Graciela ;

Gregorio, Gabriela L. ;

Moreno, Rina ;

Lutz, Maria I. ;

Panigasi, Alicia L. ;

Saligari, Liliana ;

Caballero, Mauricio T. ;

Eguees Almeida, Rodrigo M. ;

Gutierrez Meyer, Maria E. ;

Neder, Maria D. ;

Davenport, Maria C. ;

Del Valle, Maria P. ;

Santidrian, Valeria S. ;

Mosca, Guillermina ;

Garcia Dominguez, Mercedes ;

Alvarez, Liliana ;

Landa, Patricia ;

Pota, Ana ;

Bolonati, Norma ;

Dalamon, Ricardo ;

Sanchez Mercol, Victoria I. ;

Espinoza, Marco ;

Carlos Peuchot, Juan ;

Karolinski, Ariel ;

Bruno, Miriam ;

Borsa, Ana ;

Ferrero, Fernando ;

Bonina, Angel ;

Ramonet, Margarita ;

Albano, Lidia C. ;

Luedicke, Nora ;

Alterman, Elias ;

Savy, Vilma ;

Baumeister, Elsa ;

Chappell, James D. ;

Edwards, Kathryn M. ;

Melendi, Guillermina A. ;

Polack, Fernando P. .

NEW ENGLAND JOURNAL OF MEDICINE, 2010, 362 (01) :45-55

[18] Safety and immunogenicity of an inactivated subunit influenza virus vaccine combined with MF59 adjuvant emulsion in elderly subjects, immunized for three consecutive influenza seasons [J].

Minutello, M ;

Senatore, F ;

Cecchinelli, G ;

Bianchi, M ;

Andreani, T ;

Podda, A ;

Crovari, P .

VACCINE, 1999, 17 (02) :99-104

[19] MF59-adjuvanted versus non-adjuvanted influenza vaccines: Integrated analysis from a large safety database [J].

Pellegrini, Michele ;

Nicolay, Uwe ;

Lindert, Kelly ;

Groth, Nicola ;

Della Cioppa, Giovanni .

VACCINE, 2009, 27 (49) :6959-6965

[20]

Principi N, 2003, PEDIATR INFECT DIS J, V22, pS207, DOI 10.1097/01.inf.0000092188.48726.e4

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