Standard Article

Statistical Issues in Vaccine Safety Evaluation

  1. C. Paddy Farrington1,
  2. Heather J. Whitaker1,
  3. Mounia N. Hocine1,2

Published Online: 15 MAR 2008

DOI: 10.1002/9780470061572.eqr326

Encyclopedia of Statistics in Quality and Reliability

Encyclopedia of Statistics in Quality and Reliability

How to Cite

Farrington, C. P., Whitaker, H. J. and Hocine, M. N. 2008. Statistical Issues in Vaccine Safety Evaluation. Encyclopedia of Statistics in Quality and Reliability. IV.

Author Information

  1. 1

    Open University, Milton Keynes, UK

  2. 2

    INSERM, Villejuif, France

Publication History

  1. Published Online: 15 MAR 2008

Abstract

This article describes some of the main statistical methods used to evaluate the safety of vaccines. The methods are illustrated using examples of public health concerns that arose following claims of associations, both real and unproven, between vaccination and adverse events. Prelicensure evaluation, surveillance methods, and observational study designs including case-control, cohort, and case-only methods are discussed.

Keywords:

  • case-control study;
  • case series;
  • cohort study;
  • randomized controlled trial;
  • safety;
  • surveillance;
  • vaccine