Vaccine 27 (2009) 2282–2288 Contents lists available at ScienceDirect Vaccine journal homepage: www.elsevier.com/locate/vaccine Guidelines for collection, analysis and presentation of vaccine safety data in pre- and post-licensure clinical studies  Jan Bonhoeffer a,∗ , Adwoa Bentsi-Enchill b , Robert T. Chen c , Margaret C. Fisher d , Michael S. Gold e , Katharina Hartman f , Ulrich Heininger a , Bernard Hoet g , Thomas Jefferson h , Najwa Khuri-Bulos i , Katrin S. Kohl c , S. Michael Marcy j , David Nalin k , Robert Pless l , Hernan Sanabria-Rojas m , Karen Sleeman n , Robert Wise o , The Brighton Collaboration Methods Working Group 1 a University Children’s Hospital Basel, Basel, Switzerland b World Health Organization, Geneva, Switzerland c Centers for Disease Control and Prevention, Atlanta, GA, USA d The Children’s Hospital at Monmouth Medical Center, Long Branch, NJ, USA e South Australian Immunisation Coordination Unit, Adelaide, Australia f Berna Biotech AG, Bern, Switzerland g GlaxoSmithKline Biologicals, Rixensart, Belgium h Cochrane Vaccines Field and Health Reviews Ltd., Rome, Italy i Jordan University Hospital, Amman, Jordan j University of Southern California, Los Angeles, CA, USA k Consultant in Vaccinology, PE, USA l Centre for Infectious Disease Prevention and Control, Ottawa, Canada m Instituto Nacional de Salud, Lima, Peru n John Radcliffe Hospital, Oxford, United Kingdom o Food and Drug Administration, Rockville, MD, USA article info Article history: Received 9 November 2008 Accepted 12 November 2008 Available online 3 December 2008 Keywords: Vaccine Immunization Safety Guidelines 1. Preamble The following guidelines seek to standardize vaccine safety assessment by improving the accuracy and completeness of col-  Disclaimer: The findings, opinions and assertions contained in this consensus document are those of the individual scientific professional members of the working group. They do not necessarily represent the official positions of each participant’s organization (e.g., government, university, or corporation). Specifically, the findings and conclusions in this paper are those of the authors and do not necessarily rep- resent the views of the Centers for Disease Control and Prevention or the Food and Drug Administration. ∗ Corresponding author. Tel.: +41 616856565. E-mail address: secretariat@brightoncollaboration.org (J. Bonhoeffer). 1 Brighton Collaboration. lection, analysis, and presentation of information about Adverse Events Following Immunization (AEFI) in pre-and post-licensure clinical studies (e.g., randomized controlled trials, cohort studies, case-control studies, self-controlled case series). 1.1. Need for developing guidelines for collection, analysis and presentation of vaccine safety data in pre- and post-licensure clinical studies Collection of accurate and complete safety data is essential in both pre- and post-licensure studies, as well as in post-licensure passive surveillance. However, the nature of safety data collected in clinical studies, comparative or non-comparative, differs from data obtained from passive surveillance monitoring. 0264-410X/$ – see front matter. Published by Elsevier Ltd. doi:10.1016/j.vaccine.2008.11.036