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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
Beck, Bernhard
Steffen, Robert
Genton, Blaise
d'Acremont, Valérie
Hartmann, Katharina
Herzog, Christian
Published in Vaccine. 2011, vol. 29, no. 31, p. 5000-6
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(®), 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.
Keywords AdolescentAdultAgedChildChild, PreschoolDrug Toxicity/epidemiologyFemaleHepatitis A/immunology/prevention & controlHepatitis A Vaccines/administration & dosage/adverse effectsHumansIncidenceMaleMiddle AgedProduct LabelingProduct Surveillance, Postmarketing/methodsQuestionnairesYoung Adult
PMID: 21569813
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Research group Groupe Louis Loutan (médecine des Voyages et des Migrations, Médecine Tropicale, Santé Internationale) (122)
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HATZ, Christoph et al. Real-life versus package insert: a post-marketing study on adverse-event rates of the virosomal hepatitis A vaccine Epaxal® in healthy travellers. In: Vaccine, 2011, vol. 29, n° 31, p. 5000-6. https://archive-ouverte.unige.ch/unige:25505

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Deposited on : 2013-01-14

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