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

{"article_title":"Guideline for collection, analysis and presentation of safety data in clinical trials of vaccines in pregnant women.","author":"Jones CE, Munoz FM, Spiegel HM, Heininger U, Zuber PL, Edwards KM, Lambach P, Neels P, Kohl KS, Gidudu J, Hirschfeld S, Oleske JM, Khuri-Bulos N, Bauwens J, Eckert LO, Kochhar S, Bonhoeffer J, Heath PT","journal_title":"Vaccine","issn":"1873-2518","isbn":"","publication_date":"2016-12-01","volume":"34","issue":"49","first_page":"5998","page_count":"","accession_number":"27481360","doi":"10.1016\/j.vaccine.2016.07.032","publisher":"Elsevier Science","doctype":"Guideline","subjects":"Clinical Trials as Topic; Pregnancy; Vaccination adverse effects; Vaccines adverse effects; Female; Humans; Infant; Pregnancy Complications, Infectious prevention & control; Statistics as Topic; Vaccines administration & dosage","interest_area":["Obstetrics & Gynecology"," Infectious Disease & Vaccines"],"abstract":"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 \u00c2\u00a9 2016. Published by Elsevier Ltd.","url":"https:\/\/search.ebscohost.com\/login.aspx?direct=true&db=mdl&AN=27481360","isPdfLink":false,"isSAML":false,"an":"27481360","number_other":"","type_pub":"","issn_electronic":"1873-2518","languages":"English","language":"eng","date_entry":"Date Created: 20160803 Date Completed: 20171204 Latest Revision: 20220129","date_update":"20240104","titleSource":"Vaccine [Vaccine] 2016 Dec 01; Vol. 34 (49), pp. 5998-6006. Date of Electronic Publication: 2016 Jul 29.","date_pub_cy":"","type_document":"","contract_publisher":"","authored_on":"2016-12-01","description":"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.<br \/> (Copyright © 2016. Published by Elsevier Ltd.)","upload_link":"https:\/\/search.ebscohost.com\/login.aspx?direct=true&site=eds-live&scope=site&db=mdl&AN=27481360&authtype=shib&custid=ns346513&group=main&profile=eds","no_of_pages":"","authored_by":"Jones CE, Munoz FM, Spiegel HM, Heininger U, Zuber PL, Edwards KM, Lambach P, Neels P, Kohl KS, Gidudu J, Hirschfeld S, Oleske JM, Khuri-Bulos N, Bauwens J, Eckert LO, Kochhar S, Bonhoeffer J, Heath PT"}