Guideline for collection, analysis and presentation of safety data in clinical trials of vaccines in pregnant women.

Autor: Jones CE; Paediatric Infectious Diseases Research Group, Institute for Infection and Immunity, St George's, University of London, UK., Munoz FM; Baylor College of Medicine, Houston, TX, United States., Spiegel HM; Henry Jackson Foundation, Bethesda, MD, United States., Heininger U; University of Basel Children's Hospital, Basel, Switzerland., Zuber PL; Safety and Vigilance (SAV), Regulation of Medicines and other Health Technologies (RHT), Department of Essential Medicines and Health Products (EMP), Health Systems and Innovation (HIS), World Health Organization, Geneva, Switzerland., Edwards KM; Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University, Nashville, TN, United States., Lambach P; Initiative for Vaccine Research, World Health Organization, Geneva, Switzerland., Neels P; International Alliance of Biological Standardization, IABS-EU, Lyon, France., Kohl KS; Centers for Disease Control and Prevention, Atlanta, GA, United States., Gidudu J; Global Immunization Division, Center for Global Health, CDC, Atlanta, GA, United States., Hirschfeld S; Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, United States., Oleske JM; Division of Pediatrics Allergy, Immunology & Infectious Diseases, Rutgers, New Jersey Medical School, Newark, NJ, United States., Khuri-Bulos N; Infectious Disease and Vaccine Center, University of Jordan, Amman, Jordan., Bauwens J; Brighton Collaboration Foundation, Switzerland., Eckert LO; University of Washington, Seattle, WA, United States., Kochhar S; Global Healthcare Consulting, India., Bonhoeffer J; University of Basel Children's Hospital, Basel, Switzerland., Heath PT; Paediatric Infectious Diseases Research Group, Institute for Infection and Immunity, St George's, University of London, UK. Electronic address: contact@brightoncollaboration.org.
Jazyk: angličtina
Zdroj: Vaccine [Vaccine] 2016 Dec 01; Vol. 34 (49), pp. 5998-6006. Date of Electronic Publication: 2016 Jul 29.
DOI: 10.1016/j.vaccine.2016.07.032
Abstrakt: Vaccination during pregnancy is increasingly being used as an effective approach for protecting both young infants and their mothers from serious infections. Drawing conclusions from published studies in this area can be difficult because of the inability to compare vaccine trial results across different studies and settings due to the heterogeneity in the definitions of terms used to assess the safety of vaccines in pregnancy and the data collected in such studies. The guidelines proposed in this document have been developed to harmonize safety data collection in all phases of clinical trials of vaccines in pregnant women and apply to data from the mother, fetus and infant. Guidelines on the prioritization of the data to be collected is also provided to allow applicability in various geographic, cultural and resource settings, including high, middle and low-income countries.
(Copyright © 2016. Published by Elsevier Ltd.)
Databáze: MEDLINE
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