Surveillance of vaccine safety: comparison of parental reports with routine surveillance and a clinical trial

Vaccine. 2009 Mar 23;27(14):2042-7. doi: 10.1016/j.vaccine.2009.01.131. Epub 2009 Feb 6.

Abstract

One way to maintain confidence in vaccination programmes is to improve monitoring of immunisation safety. We studied active parental reporting of adverse events after a booster dose of diphtheria-tetanus toxoid (DT). 7193 children received the vaccine. Questionnaires were submitted by 84.2% of the parents, who reported reactions for 9.2% of the children. Four percent of events were classified as moderate/severe by interviews. Relative risk of redness and swelling reported was 0.24 (95% CI, 0.13-0.42) compared to a clinical trial, while it was 71.0 (44-114) compared to passive surveillance. Active surveillance by parental reports is a useful complement to passive surveillance of childhood immunisations to generate hypotheses for evaluation in controlled studies.

Publication types

  • Comparative Study

MeSH terms

  • Child
  • Clinical Trials as Topic
  • Diphtheria-Tetanus Vaccine / administration & dosage*
  • Diphtheria-Tetanus Vaccine / adverse effects*
  • Edema / etiology
  • Humans
  • Immunization, Secondary / adverse effects*
  • Injections
  • Interviews as Topic
  • Safety
  • Sentinel Surveillance*
  • Surveys and Questionnaires
  • Sweden

Substances

  • Diphtheria-Tetanus Vaccine