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Guidance for the collection of case report form variables to assess safety in clinical trials of vaccines in pregnancy.

Jones, CE; Munoz, FM; Kochhar, S; Vergnano, S; Cutland, CL; Steinhoff, M; Black, S; Heininger, U; Bonhoeffer, J; Heath, PT (2016) Guidance for the collection of case report form variables to assess safety in clinical trials of vaccines in pregnancy. Vaccine, 34 (49). pp. 6007-6014. ISSN 1873-2518 https://doi.org/10.1016/j.vaccine.2016.07.007
SGUL Authors: Heath, Paul Trafford Jones, Christine Elizabeth

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Abstract

Vaccination in pregnancy is an effective strategy to prevent serious infections in mothers and their infants. Safety of this strategy is of principal importance to all stakeholders. As the number of studies assessing safety of vaccines in pregnancy increases, the need to ensure consistent collection and reporting of critical data to allow comparisons and data pooling becomes more important. The Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) project aims to improve data collection and create a shared understanding of maternal, fetal and neonatal outcomes in order to progress the global agenda for vaccination in pregnancy. The guidance in this document has been developed to harmonize the data collected in case report forms used for safety monitoring in clinical trials of vaccination in pregnant women. Data to be collected is prioritized to allow applicability in diverse research settings, including low and middle-income countries. Standardized data will enable the research community to have a common base upon which to conduct meta-analyses, strengthening the applicability of outcomes to different settings.

Item Type: Article
Additional Information: © 2016 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
Keywords: Adverse event, Case report form, Clinical trials, Guidance, Immunization, Pregnancy, Safety, Vaccines, Adverse event, Immunization, Pregnancy, Guidance, Clinical trials, Vaccines, Safety, Case report form, Virology, 06 Biological Sciences, 07 Agricultural And Veterinary Sciences, 11 Medical And Health Sciences
SGUL Research Institute / Research Centre: Academic Structure > Infection and Immunity Research Institute (INII)
Journal or Publication Title: Vaccine
ISSN: 1873-2518
Language: eng
Dates:
DateEvent
1 December 2016Published
25 October 2016Published Online
6 July 2016Accepted
Publisher License: Creative Commons: Attribution 4.0
Projects:
Project IDFunderFunder ID
OPP1119788Bill and Melinda Gates Foundationhttp://dx.doi.org/10.13039/100000865
PubMed ID: 27793485
Web of Science ID: WOS:000390514000004
Go to PubMed abstract
URI: http://openaccess.sgul.ac.uk/id/eprint/108356
Publisher's version: https://doi.org/10.1016/j.vaccine.2016.07.007

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