title: Safety of MF59-adjuvanted versus non-adjuvanted influenza vaccines in children and adolescents: an integrated analysis.
abstract: 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.
authors.affiliation: Center for Global Health and Division of Infectious Diseases, Cincinnati Children's Hospital, 3333 Burnet Ave, Cincinnati, OH 45326, USA. stevblack@gmail.com
authors.forename: Steven
authors.initials: S
authors.lastname: Black
authors.forename: Giovanni
authors.initials: G
authors.lastname: Della Cioppa
authors.forename: Anne
authors.initials: A
authors.lastname: Malfroot
authors.forename: Pantaleo
authors.initials: P
authors.lastname: Nacci
authors.forename: Uwe
authors.initials: U
authors.lastname: Nicolay
authors.forename: Michele
authors.initials: M
authors.lastname: Pellegrini
authors.forename: Etienne
authors.initials: E
authors.lastname: Sokal
authors.forename: André
authors.initials: A
authors.lastname: Vertruyen
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000009:adverse effects*; D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D006801:Humans; D007223:Infant; D007252:Influenza Vaccines / Q000009:adverse effects* / Q000276:immunology; D007251:Influenza, Human / Q000276:immunology / Q000517:prevention & control*; D011136:Polysorbates / Q000008:administration & dosage / Q000009:adverse effects*; D013185:Squalene / Q000008:administration & dosage / Q000009:adverse effects*
chemical_list: D000276:Adjuvants, Immunologic; D007252:Influenza Vaccines; C089950:MF59 oil emulsion; D011136:Polysorbates; D013185:Squalene