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Real-life versus package insert : a post-marketing study on adverse-event rates of the virosomal hepatitis A vaccine Epaxal® in healthy travellers

Hatz, Christoph and Beck, Bernhard and Steffen, Robert and Genton, Blaise and d'Acremont, Valérie and Loutan, Louis and Hartmann, Katharina and Herzog, Christian. (2011) Real-life versus package insert : a post-marketing study on adverse-event rates of the virosomal hepatitis A vaccine Epaxal® in healthy travellers. Vaccine, Vol. 29, H. 31. S. 5000-5006.

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Official URL: http://edoc.unibas.ch/dok/A6002320

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Abstract

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((R)), 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((R)) 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.
Faculties and Departments:?? 478834 ??
03 Faculty of Medicine > Departement Public Health > Sozial- und Präventivmedizin > Travel Clinic (Neumayr)
09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH) > Medicine > Travel Clinic (Neumayr)
09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH) > Department of Medical Parasitology and Infection Biology > Clinical Immunology (Daubenberger)
UniBasel Contributors:Genton, Blaise and Hatz, Christoph
Item Type:Article, refereed
Bibsysno:Link to catalogue
Publisher:Elsevier
ISSN:0264-410X
Note:Publication type according to Uni Basel Research Database: Journal article
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Last Modified:01 Mar 2013 11:08
Deposited On:08 Nov 2012 16:08

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