TY - JOUR
T1 - 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
AU - Diez-Domingo, Javier
AU - de Martino, Maurizio
AU - Lopez, Jose Garcia Sicilia
AU - Zuccotti, Gian Vincenzo
AU - Icardi, Giancarlo
AU - Villani, Alberto
AU - Moreno-Perez, David
AU - Hernández, María Méndez
AU - Aldeán, Javier Álvarez
AU - Mateen, Ahmed Abdul
AU - Enweonye, Igwebuike
AU - de Rooij, Richard
AU - Chandra, Richa
PY - 2016/8/1
Y1 - 2016/8/1
N2 - 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).
AB - 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).
KW - At-risk children
KW - Cell culture-derived
KW - Influenza vaccine
KW - Safety
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U2 - 10.1016/j.ijid.2016.06.018
DO - 10.1016/j.ijid.2016.06.018
M3 - Article
AN - SCOPUS:84990064452
VL - 49
SP - 171
EP - 178
JO - International Journal of Infectious Diseases
JF - International Journal of Infectious Diseases
SN - 1201-9712
ER -