کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
3361626 | 1592045 | 2016 | 8 صفحه PDF | دانلود رایگان |
• This is the first study to assess the safety of cell-derived vaccine in at-risk children.
• The cell culture-derived (TIVc) and egg-derived (TIV) trivalent influenza vaccines were generally well tolerated in children at risk of influenza.
• The TIVc and TIV had similar safety profiles in children at risk of influenza.
• There were no cases of severe fever or serious adverse events (AEs) with either TIVc or TIV.
• The most common solicited AEs were pain, irritability, and headache.
SummaryBackgroundThis 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.MethodsFour 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.ResultsAfter 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.ConclusionTIVc and TIV had acceptable tolerability and similar safety profiles in at-risk children (NCT01998477).
Journal: International Journal of Infectious Diseases - Volume 49, August 2016, Pages 171–178