title: 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.
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.
  
  
  CONCLUSIONS
  TIVc and TIV had acceptable tolerability and similar safety profiles in at-risk children (NCT01998477).
authors.affiliation: Vaccine Research Department. FISABIO-Public Health, Valencia, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Diez-Domingo
authors.affiliation: Anna Meyer Children's University Hospital, Florence, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: de Martino
authors.affiliation: Hospital Universitario HM Sanchinarro, Madrid, Spain.
authors.forename: Jose Garcia-Sicilia
authors.initials: JG
authors.lastname: Lopez
authors.affiliation: Department of Paediatrics, Children Hospital V. Buzzi, University of Milan, Milan, Italy.
authors.forename: Gian Vincenzo
authors.initials: GV
authors.lastname: Zuccotti
authors.affiliation: 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.
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Icardi
authors.affiliation: Department of General Paediatrics and Infectious Diseases, Bambino Gesù Children Hospital, Rome, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Villani
authors.affiliation: Paediatrics Department, Hospital Materno Infantil, Málaga, Spain.
authors.forename: David
authors.initials: D
authors.lastname: Moreno-Perez
authors.affiliation: Hospital Germans Trias i Pujol, Barcelona, Spain.
authors.forename: María Méndez
authors.initials: MM
authors.lastname: Hernández
authors.affiliation: Agencia Sanitaria Hospital Costa del Sol, Marbella, Spain.
authors.forename: Javier Álvarez
authors.initials: JÁ
authors.lastname: Aldeán
authors.affiliation: Novartis Pharmaceuticals Canada Inc., 385, Bouchard Blvd, Dorval, Quebec H9S 1A9, Canada. Electronic address: ahmed.abdul_mateen@novartis.com.
authors.forename: Ahmed Abdul
authors.initials: AA
authors.lastname: Mateen
authors.affiliation: Novartis Pharma BV, Amsterdam, Netherlands.
authors.forename: Igwebuike
authors.initials: I
authors.lastname: Enweonye
authors.affiliation: Novartis Pharma BV, Amsterdam, Netherlands.
authors.forename: Richard
authors.initials: R
authors.lastname: de Rooij
authors.affiliation: Novartis Vaccines and Diagnostics Inc., Cambridge, Massachusetts, USA.
authors.forename: Richa
authors.initials: R
authors.lastname: Chandra
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007252:Influenza Vaccines / Q000009:adverse effects*; D007251:Influenza, Human / Q000150:complications*; D008297:Male; D014611:Vaccination / Q000009:adverse effects*
chemical_list: D007252:Influenza Vaccines
keywords: At-risk children; Cell culture-derived; Influenza vaccine; Safety