PMID- 21569813
OWN - NLM
STAT- MEDLINE
DCOM- 20111018
LR  - 20191210
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Linking)
VI  - 29
IP  - 31
DP  - 2011 Jul 12
TI  - Real-life versus package insert: a post-marketing study on adverse-event rates of 
      the virosomal hepatitis A vaccine Epaxal(R) in healthy travellers.
PG  - 5000-6
LID - 10.1016/j.vaccine.2011.04.099 [doi]
AB  - 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.
CI  - Copyright (c) 2011 Elsevier Ltd. All rights reserved.
FAU - Hatz, Christoph
AU  - Hatz C
AD  - Medical Department, Swiss Tropical and Public Health Institute Basel, 
      Switzerland. Christoph.Hatz@unibas.ch
FAU - Beck, Bernhard
AU  - Beck B
FAU - Steffen, Robert
AU  - Steffen R
FAU - Genton, Blaise
AU  - Genton B
FAU - d'Acremont, Valerie
AU  - d'Acremont V
FAU - Loutan, Louis
AU  - Loutan L
FAU - Hartmann, Katharina
AU  - Hartmann K
FAU - Herzog, Christian
AU  - Herzog C
LA  - eng
PT  - Evaluation Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20110511
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Hepatitis A Vaccines)
RN  - 0 (epaxal berna)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Child
MH  - Child, Preschool
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology
MH  - Female
MH  - Hepatitis A/immunology/*prevention & control
MH  - Hepatitis A Vaccines/administration & dosage/*adverse effects
MH  - Humans
MH  - Incidence
MH  - Male
MH  - Middle Aged
MH  - *Product Labeling
MH  - Product Surveillance, Postmarketing/*methods
MH  - Surveys and Questionnaires
MH  - Young Adult
EDAT- 2011/05/17 06:00
MHDA- 2011/10/19 06:00
CRDT- 2011/05/17 06:00
PHST- 2010/09/02 00:00 [received]
PHST- 2011/04/12 00:00 [revised]
PHST- 2011/04/26 00:00 [accepted]
PHST- 2011/05/17 06:00 [entrez]
PHST- 2011/05/17 06:00 [pubmed]
PHST- 2011/10/19 06:00 [medline]
AID - S0264-410X(11)00654-2 [pii]
AID - 10.1016/j.vaccine.2011.04.099 [doi]
PST - ppublish
SO  - Vaccine. 2011 Jul 12;29(31):5000-6. doi: 10.1016/j.vaccine.2011.04.099. Epub 2011 
      May 11.