%0 Journal Article
%A Diez-Domingo, Javier
%A de Martino, Maurizio
%A Garcia-Sicilia Lopez, Jose
%A Zuccotti, Gian Vincenzo
%A Icardi, Giancarlo
%A Villani, Alberto
%A Moreno-Perez, David
%A Méndez Hernández, María
%A Álvarez Aldeán, Javier
%A Mateen, Ahmed Abdul
%A Enweonye, Igwebuike
%A de Rooij, Richard
%A Chandra, Richa
%T Safety and tolerability of cell culture-derived and egg-derived trivalent influenza vaccines in 3 to <18-year-old children and adolescents at risk of influenza-related complications.
%D 2016
%@ 1201-9712
%U http://hdl.handle.net/10668/2676
%X BACKGROUNDThis descriptive, non-comparative, phase III study evaluated the safety and tolerability of cell culture-derived (TIVc) and egg-derived (TIV) seasonal influenza vaccines in children at risk of influenza-related complications.METHODSFour hundred and thirty subjects were randomized 2:1 to TIVc or TIV. Subjects aged 3 to <9 years received one dose (if previously vaccinated, n=89) or two doses (if not previously vaccinated, n=124) of the study vaccines; the 9 to <18-year-olds (n=213) received one dose. Reactogenicity was assessed for 7 days after vaccination; safety was monitored for 6 months.RESULTSAfter any vaccination, the most frequently reported solicited local adverse event (AE) was tenderness/pain (TIVc 44%, 66%, 53% and TIV 56%, 51%, 65% in the age groups 3 to <6 years, 6 to <9 years, and 9 to <18 years, respectively) and the systemic AE was irritability (22% TIVc, 24% TIV) in 3 to <6-year-olds and headache in 6 to <9-year-olds (20% TIVc, 13% TIV) and 9 to <18-year-olds (21% TIVc, 26% TIV). There were no cases of severe fever (≥40°C). No vaccine-related serious AEs were noted. New onset of chronic disease was reported in ≤1% of subjects.CONCLUSIONTIVc and TIV had acceptable tolerability and similar safety profiles in at-risk children (NCT01998477).
%K Safety
%K Cell culture-derived
%K Influenza vaccine
%K At-risk children
%K Vacunas contra la Influenza
%K Niño
%K Adolescente
%K Vacunación
%K Humanos
%K Preescolar
%K Estaciones del año
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