tetano
Editor, Senior Moderator
Int J Infect Dis. 2016 Jun 22. pii: S1201-9712(16)31103-1. doi: 10.1016/j.ijid.2016.06.018. [Epub ahead of print]
[h=1]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.[/h] Diez-Domingo J[SUP]1[/SUP], de Martino M[SUP]2[/SUP], Lopez JG[SUP]3[/SUP], Zuccotti GV[SUP]4[/SUP], Icardi G[SUP]5[/SUP], Villani A[SUP]6[/SUP], Moreno-Perez D[SUP]7[/SUP], Hern?ndez MM[SUP]8[/SUP], Alde?n J?[SUP]9[/SUP], Mateen AA[SUP]10[/SUP], Enweonye I[SUP]11[/SUP], de Rooij R[SUP]11[/SUP], Chandra R[SUP]12[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] 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.
[h=4]METHODS:[/h] 430 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.
[h=4]RESULTS:[/h] 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 3 to <6, 6 to <9, and 9- to <18-year olds, 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 diseases was reported in ≤1% of subjects.
[h=4]CONCLUSION:[/h] TIVc and TIV had acceptable tolerability and similar safety profiles in at-risk children (NCT01998477).
Copyright ? 2016. Published by Elsevier Ltd.
[h=4]KEYWORDS:[/h] At-risk children; Cell culture-derived; Influenza vaccine; Safety
PMID: 27343983 DOI: 10.1016/j.ijid.2016.06.018
[PubMed - as supplied by publisher]
[h=1]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.[/h] Diez-Domingo J[SUP]1[/SUP], de Martino M[SUP]2[/SUP], Lopez JG[SUP]3[/SUP], Zuccotti GV[SUP]4[/SUP], Icardi G[SUP]5[/SUP], Villani A[SUP]6[/SUP], Moreno-Perez D[SUP]7[/SUP], Hern?ndez MM[SUP]8[/SUP], Alde?n J?[SUP]9[/SUP], Mateen AA[SUP]10[/SUP], Enweonye I[SUP]11[/SUP], de Rooij R[SUP]11[/SUP], Chandra R[SUP]12[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] 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.
[h=4]METHODS:[/h] 430 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.
[h=4]RESULTS:[/h] 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 3 to <6, 6 to <9, and 9- to <18-year olds, 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 diseases was reported in ≤1% of subjects.
[h=4]CONCLUSION:[/h] TIVc and TIV had acceptable tolerability and similar safety profiles in at-risk children (NCT01998477).
Copyright ? 2016. Published by Elsevier Ltd.
[h=4]KEYWORDS:[/h] At-risk children; Cell culture-derived; Influenza vaccine; Safety
PMID: 27343983 DOI: 10.1016/j.ijid.2016.06.018
[PubMed - as supplied by publisher]