RT Journal Article
T1 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.
A1 Diez-Domingo, Javier
A1 de Martino, Maurizio
A1 Garcia-Sicilia Lopez, Jose
A1 Zuccotti, Gian Vincenzo
A1 Icardi, Giancarlo
A1 Villani, Alberto
A1 Moreno-Perez, David
A1 Méndez Hernández, María
A1 Álvarez Aldeán, Javier
A1 Mateen, Ahmed Abdul
A1 Enweonye, Igwebuike
A1 de Rooij, Richard
A1 Chandra, Richa
K1 Safety
K1 Cell culture-derived
K1 Influenza vaccine
K1 At-risk children
K1 Vacunas contra la Influenza
K1 Niño
K1 Adolescente
K1 Vacunación
K1 Humanos
K1 Preescolar
K1 Estaciones del año
AB 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).
PB Elsevier
SN 1201-9712
YR 2016
FD 2016-08
LK http://hdl.handle.net/10668/2676
UL http://hdl.handle.net/10668/2676
LA en
NO Diez-Domingo J, de Martino M, Lopez JG, Zuccotti GV, Icardi G, Villani A, et al. 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. Int. J. Infect. Dis. 2016 ; 49:171-8
NO Journal Article;
NO This study was sponsored by Novartis Vaccines and Diagnostics, Inc.
DS RISalud
RD Apr 5, 2025