Guidelines for collection, analysis and presentation of vaccine safety data in pre- and post-licensure clinical studies

Jan Bonhoeffer; Adwoa Bentsi-Enchill; Robert T. Chen; Margaret C. Fisher; Michael S. Gold; Katharina Hartman; Ulrich Heininger; Bernard Hoet; Thomas Jefferson; Najwa Khuri-Bulos; Katrin S. Kohl; S. Michael Marcy; David Nalin; Robert Pless; Hernan Sanabria-Rojas; Karen Sleeman; Robert Wise; The Brighton Collaboration Methods Working Group

doi:10.1016/j.vaccine.2008.11.036

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Guidelines for collection, analysis and presentation of vaccine safety data in pre- and post-licensure clinical studies

Journal article

Peer reviewed

Guidelines for collection, analysis and presentation of vaccine safety data in pre- and post-licensure clinical studies

Jan Bonhoeffer, Adwoa Bentsi-Enchill, Robert T. Chen, Margaret C. Fisher, Michael S. Gold, Katharina Hartman, Ulrich Heininger, Bernard Hoet, Thomas Jefferson, Najwa Khuri-Bulos, …

Vaccine, v 27(16), pp 2282-2288

06 Apr 2009

DOI: https://doi.org/10.1016/j.vaccine.2008.11.036

PMID: 19056451

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Title: Guidelines for collection, analysis and presentation of vaccine safety data in pre- and post-licensure clinical studies
Creators: Jan Bonhoeffer - University Children’s Hospital Basel
Adwoa Bentsi-Enchill - World Health Organization, Geneva, Switzerland
Robert T. Chen - Centers for Disease Control and Prevention, Atlanta, GA, USA
Margaret C. Fisher - Monmouth Medical Center
Michael S. Gold - South Australian Immunisation Coordination Unit, Adelaide, Australia
Katharina Hartman - Biotech
Ulrich Heininger - University Children’s Hospital Basel
Bernard Hoet - Biologicals
Thomas Jefferson - Cochrane Vaccines Field and Health Reviews Ltd., Rome, Italy
Najwa Khuri-Bulos - Jordan University Hospital, Amman, Jordan
Katrin S. Kohl - Centers for Disease Control and Prevention, Atlanta, GA, USA
S. Michael Marcy - University of Southern California, Los Angeles, CA, USA
David Nalin - Consultant in Vaccinology, PE, USA
Robert Pless - Centre for Infectious Disease Prevention and Control, Ottawa, Canada
Hernan Sanabria-Rojas - Instituto Nacional de Salud, Lima, Peru
Karen Sleeman - John Radcliffe Hospital
Robert Wise - Food and Drug Administration
The Brighton Collaboration Methods Working Group
Publication Details: Vaccine, v 27(16), pp 2282-2288
Publisher: Elsevier
Number of pages: 7
Resource Type: Journal article
Language: English
Academic Unit: Pediatrics
Web of Science ID: WOS:000264954500012
Scopus ID: 2-s2.0-61849094267
Other Identifier: 991021930431404721

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Collaboration types: Industry collaboration; Domestic collaboration; International collaboration
Web of Science research areas: Immunology; Medicine, Research & Experimental

Guidelines for collection, analysis and presentation of vaccine safety data in pre- and post-licensure clinical studies

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