Javier Diez-Domingo1, Maurizio de Martino2, Jose Garcia-Sicilia Lopez3, Gian Vincenzo Zuccotti4, Giancarlo Icardi5, Alberto Villani6, David Moreno-Perez7, María Méndez Hernández8, Javier Álvarez Aldeán9, Ahmed Abdul Mateen10, Igwebuike Enweonye11, Richard de Rooij11, Richa Chandra12. 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.
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).
RCT Entities:
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).