Safety of MF59-adjuvanted versus non-adjuvanted influenza vaccines in children and adolescents: an integrated analysis.
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.
Black
Steven
S
Center for Global Health and Division of Infectious Diseases, Cincinnati Children's Hospital, 3333 Burnet Ave, Cincinnati, OH 45326, USA. stevblack@gmail.com
Della Cioppa
Giovanni
G
Malfroot
Anne
A
Nacci
Pantaleo
P
Nicolay
Uwe
U
Pellegrini
Michele
M
Sokal
Etienne
E
Vertruyen
André
A
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*
D000276:Adjuvants, Immunologic; D007252:Influenza Vaccines; C089950:MF59 oil emulsion; D011136:Polysorbates; D013185:Squalene