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

• Main Authors: Javier Diez-Domingo, Maurizio de Martino, Jose Garcia-Sicilia Lopez, Gian Vincenzo Zuccotti, Giancarlo Icardi, Alberto Villani, David Moreno-Perez, María Méndez Hernández, Javier Álvarez Aldeán, Ahmed Abdul Mateen, Igwebuike Enweonye, Richard de Rooij, Richa Chandra
• Format: Article
• Language: English
• Published: Elsevier 2016-08-01
• Series: International Journal of Infectious Diseases
• Subjects: Safety; Cell culture-derived; Influenza vaccine; At-risk children
• Online Access: http://www.sciencedirect.com/science/article/pii/S1201971216311031
• ISSN: 1201-9712; 1878-3511

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).