期刊
VACCINE
卷 34, 期 49, 页码 5998-6006出版社
ELSEVIER SCI LTD
DOI: 10.1016/j.vaccine.2016.07.032
关键词
Adverse event; Immunization; Pregnancy; Guidelines; Clinical trials; Vaccines; Safety
资金
- Bill & Melinda Gates Foundation [OPP1119788]
- Bill and Melinda Gates Foundation [OPP1119788] Funding Source: Bill and Melinda Gates Foundation
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. (C) 2016 Published by Elsevier Ltd.
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