کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
10969147 | 1102925 | 2011 | 7 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Real-life versus package insert: A post-marketing study on adverse-event rates of the virosomal hepatitis A vaccine Epaxal® in healthy travellers
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کلمات کلیدی
SPCMedDRAHAVAEFISafety - ایمنیsummary of product characteristics - خلاصه ای از مشخصات محصولSelf-reporting - خود گزارش دادنMedical Dictionary for Regulatory Activities - دیکشنری پزشکی برای فعالیت های نظارتیAdverse Events Following Immunization - رویدادهای ناخوشایند بعد از ایمن سازیSOC - سیستم روی یک تراشهAdverse events - عوارض جانبیhepatitis A vaccine - واکسن هپاتیت Ahepatitis A virus - ویروس هپاتیت A
موضوعات مرتبط
علوم زیستی و بیوفناوری
ایمنی شناسی و میکروب شناسی
ایمونولوژی
پیش نمایش صفحه اول مقاله

چکیده انگلیسی
There are various methods to collect adverse events (AEs) in clinical trials. The methods how AEs are collected in vaccine trials is of special interest: solicited reporting can lead to over-reporting events that have little or no biological relationship to the vaccine. We assessed the rate of AEs listed in the package insert for the virosomal hepatitis A vaccine Epaxal®, comparing data collected by solicited or unsolicited self-reporting. In an open, multi-centre post-marketing study, 2675 healthy travellers received single doses of vaccine administered intramuscularly. AEs were recorded based on solicited and unsolicited questioning during a four-day period after vaccination. A total of 2541 questionnaires could be evaluated (95.0% return rate). Solicited self-reporting resulted in significantly higher (p < 0.0001) rates of subjects with AEs than unsolicited reporting, both at baseline (18.9% solicited versus 2.1% unsolicited systemic AEs) and following immunization (29.6% versus 19.3% local AEs; 33.8% versus 18.2% systemic AEs). This could indicate that actual reporting rates of AEs with Epaxal® may be substantially lower than described in the package insert. The distribution of AEs differed significantly between the applied methods of collecting AEs. The most common AEs listed in the package insert were reported almost exclusively with solicited questioning. The reporting of local AEs was more likely than that of systemic AEs to be influenced by subjects' sex, age and study centre. Women reported higher rates of AEs than men. The results highlight the need for detailing the methods how vaccine tolerability was reported and assessed.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Vaccine - Volume 29, Issue 31, 12 July 2011, Pages 5000-5006
Journal: Vaccine - Volume 29, Issue 31, 12 July 2011, Pages 5000-5006
نویسندگان
Christoph Hatz, Bernhard Beck, Robert Steffen, Blaise Genton, Valérie d'Acremont, Louis Loutan, Katharina Hartmann, Christian Herzog,