Document Detail


Research on vaccines during pregnancy: Protocol design and assessment of safety.
MedLine Citation:
PMID:  23906888     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
The Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases, National Institutes of Health organized a series of conferences, entitled "Enrolling Pregnant Women in Clinical Trials of Vaccines and Therapeutics", to discuss study design and the assessment of safety in clinical trials conducted in pregnant women. A panel of experts was charged with developing guiding principles for the design of clinical trials and the assessment of safety of vaccines during pregnancy. Definitions and a grading system to evaluate local and systemic reactogenicity, adverse events, and other events associated with pregnancy and delivery were developed. The purpose of this report is to provide investigators interested in vaccine research in pregnancy with a basic set of tools to design and implement maternal immunization studies which may be conducted more efficiently using consistent definitions and grading of adverse events that would allow the comparison of safety reports from different trials. These guidelines and safety assessment tools may be modified to meet the needs of each particular protocol and based on evidence collected as investigators use them in clinical trials in different settings and share their findings and expertise.
Authors:
Flor M Munoz; Jeanne S Sheffield; Richard H Beigi; Jennifer S Read; Geeta K Swamy; Indira Jevaji; Sonja A Rasmussen; Kathryn M Edwards; Kimberly B Fortner; Shital M Patel; Catherine Y Spong; Kevin Ault; R Philips Heine; Mirjana Nesin
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2013-7-29
Journal Detail:
Title:  Vaccine     Volume:  -     ISSN:  1873-2518     ISO Abbreviation:  Vaccine     Publication Date:  2013 Jul 
Date Detail:
Created Date:  2013-8-2     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8406899     Medline TA:  Vaccine     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2013. Published by Elsevier Ltd.
Affiliation:
Department of Pediatrics, Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX 77030, USA. Electronic address: florm@bcm.edu.
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