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  3. 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

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

Fecha de publicación:

Autores de FISABIO

  • Javier Diez Domingo

    Autor

Autores ajenos a FISABIO

  • de Martino M
  • Lopez JG
  • Zuccotti GV
  • Icardi G
  • Villani A
  • Moreno-Perez D
  • Hernández MM
  • Aldeán JÁ
  • Mateen AA
  • Enweonye I
  • de Rooij R
  • Chandra R

Grupos de Investigación

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 degrees 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). (C) 2016 The Author(s). Published by Elsevier Ltd on behalf of International Society for Infectious Diseases.

Datos de la publicación

ISSN/ISSNe:
1201-9712, 1878-3511

INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES  ELSEVIER SCI LTD

Tipo:
Article
Páginas:
171-178
PubMed:
27343983

Citas Recibidas en Web of Science: 3

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Keywords

  • Safety; Cell culture-derived; Influenza vaccine; At-risk children

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