Safety and tolerability of cell culture-derived and egg-derived trivalent influenza vaccines in 3 to Javier Diez-Domingo  1 , Maurizio de Martino  2 , Jose Garcia-Sicilia Lopez  3 , Gian Vincenzo Zuccotti  4 , Giancarlo Icardi  5 , Alberto Villani  6 , David Moreno-Perez  7 , María Méndez Hernández  8 , Javier Álvarez Aldeán  9 , Ahmed Abdul Mateen  10 , Igwebuike Enweonye  11 , Richard de Rooij  11 , Richa Chandra  12 Affiliations Expand Affiliations 1 Vaccine Research Department. FISABIO-Public Health, Valencia, Spain. 2 Anna Meyer Children's University Hospital, Florence, Italy. 3 Hospital Universitario HM Sanchinarro, Madrid, Spain. 4 Department of Paediatrics, Children Hospital V. Buzzi, University of Milan, Milan, Italy. 5 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. 6 Department of General Paediatrics and Infectious Diseases, Bambino Gesù Children Hospital, Rome, Italy. 7 Paediatrics Department, Hospital Materno Infantil, Málaga, Spain. 8 Hospital Germans Trias i Pujol, Barcelona, Spain. 9 Agencia Sanitaria Hospital Costa del Sol, Marbella, Spain. 10 Novartis Pharmaceuticals Canada Inc., 385, Bouchard Blvd, Dorval, Quebec H9S 1A9, Canada. Electronic address: ahmed.abdul_mateen@novartis.com. 11 Novartis Pharma BV, Amsterdam, Netherlands. 12 Novartis Vaccines and Diagnostics Inc., Cambridge, Massachusetts, USA. PMID: 27343983 DOI: 10.1016/j.ijid.2016.06.018 Free article Item in Clipboard

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).

Keywords: At-risk children; Cell culture-derived; Influenza vaccine; Safety.

Copyright © 2016 The Author(s). Published by Elsevier Ltd.. All rights reserved.