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
Articolo
Data di Pubblicazione:
2016
Citazione:
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 / J. Diez Domingo, M. de Martino, J.G. Lopez, G.V. Zuccotti, G. Icardi, A. Villani, D. Moreno Perez, M.M. Hernández, J.Á. Aldeán, A.A. Mateen, I. Enweonye, R. de Rooij, R. Chandra. - In: INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES. - ISSN 1201-9712. - 49:(2016 Aug), pp. 171-178. [10.1016/j.ijid.2016.06.018]
Abstract:
Background
This 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.
Methods
Four 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.
Results
After 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.
Conclusion
TIVc and TIV had acceptable tolerability and similar safety profiles in at-risk children (NCT01998477).
Tipologia IRIS:
01 - Articolo su periodico
Keywords:
at-risk children; cell culture-derived; Influenza vaccine; safety
Elenco autori:
J. Diez Domingo, M. de Martino, J.G. Lopez, G.V. Zuccotti, G. Icardi, A. Villani, D. Moreno Perez, M.M. Hernández, J.Á. Aldeán, A.A. Mateen, I. Enweonye, R. de Rooij, R. Chandra
Link alla scheda completa: