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
Por:
Diez-Domingo J, 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 and Chandra R
Publicada:
1 ago 2016
Resumen:
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.
Filiaciones:
:
Vaccine Research Department. FISABIO-Public Health, Valencia, Spain
de Martino M:
Anna Meyer Children's University Hospital, Florence, Italy
Lopez JG:
Hospital Universitario HM Sanchinarro, Madrid, Spain
Zuccotti GV:
Department of Paediatrics, Children Hospital V. Buzzi, University of Milan, Milan, Italy
Icardi G:
Department of Health Sciences, University of Genoa and I.R.C.C.S. University Hospital, San Martino-IST National Institute for Cancer Research, Genoa, Italy
Villani A:
Department of General Paediatrics and Infectious Diseases, Bambino Gesù Children Hospital, Rome, Italy
Moreno-Perez D:
Paediatrics Department, Hospital Materno Infantil, Málaga, Spain
Hernández MM:
Hospital Germans Trias i Pujol, Barcelona, Spain
Aldeán JÁ:
Agencia Sanitaria Hospital Costa del Sol, Marbella, Spain
Mateen AA:
Novartis Pharmaceuticals Canada Inc., 385, Bouchard Blvd, Dorval, Quebec H9S 1A9, Canada.
Enweonye I:
Novartis Pharma BV, Amsterdam, Netherlands
de Rooij R:
Novartis Pharma BV, Amsterdam, Netherlands
Chandra R:
Novartis Vaccines and Diagnostics Inc., Cambridge, Massachusetts, USA
Green Published, gold
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