Guidelines for collection, analysis and presentation of vaccine safety data in surveillance systems

The proposed guidelines are also relevant for assessment of adverse events following future vaccines, including those targeting chronic diseases, (e.g. diabetes mellitus, rheumatoid arthritis), therapeutic vaccines (e.g. tumor vaccines), as well as DNA vaccines, mucosal vaccines, or vaccines with sl...

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Bibliographic Details
Published in:Vaccine 2009-04, Vol.27 (16), p.2289-2297
Main Authors: Bonhoeffer, Jan, Bentsi-Enchill, Adwoa, Chen, Robert T, Fisher, Margaret C, Gold, Michael S, Hartman, Katharina, Heininger, Ulrich, Hoet, Bernard, Jefferson, Thomas, Khuri-Bulos, Najwa, Kohl, Katrin, Marcy, S. Michael, Nalin, David, Pless, Robert, Sanabria-Rojas, Hernan, Sleeman, Karen, Wise, Robert
Format: Article
Language:English
Subjects:
Allergy and Immunology
Applied microbiology
Biological and medical sciences
Clinical trials
Collaboration
Data Collection - methods
Fundamental and applied biological sciences. Psychology
Guidelines
Humans
Immunization
Immunization - adverse effects
Licenses
Methods
Microbiology
Rheumatoid arthritis
Safety
Statistics as Topic - methods
Surveillance
Vaccine
Vaccines
Vaccines - adverse effects
Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)
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Summary:The proposed guidelines are also relevant for assessment of adverse events following future vaccines, including those targeting chronic diseases, (e.g. diabetes mellitus, rheumatoid arthritis), therapeutic vaccines (e.g. tumor vaccines), as well as DNA vaccines, mucosal vaccines, or vaccines with slow-release delivery systems. [...]we would like to thank the members of the WHO/CIOMS Working Group on Vaccine Pharmacovigilance (http://www.cioms.ch/frame_current_programme.htm) for the review of, constructive comments on, and endorsement of this document.
ISSN:0264-410X
1873-2518
DOI:10.1016/j.vaccine.2008.11.035