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Global alignment of immunization safety assessment in pregnancy - The GAIA project.

Bonhoeffer, J; Kochhar, S; Hirschfeld, S; Heath, PT; Jones, CE; Bauwens, J; Honrado, Á; Heininger, U; Muñoz, FM; Eckert, L; et al. Bonhoeffer, J; Kochhar, S; Hirschfeld, S; Heath, PT; Jones, CE; Bauwens, J; Honrado, Á; Heininger, U; Muñoz, FM; Eckert, L; Steinhoff, M; Black, S; Padula, M; Sturkenboom, M; Buttery, J; Pless, R; Zuber, P; GAIA project participants (2016) Global alignment of immunization safety assessment in pregnancy - The GAIA project. Vaccine, 34 (49). pp. 5993-5997. ISSN 1873-2518 https://doi.org/10.1016/j.vaccine.2016.07.006
SGUL Authors: Heath, Paul Trafford Jones, Christine Elizabeth

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Abstract

Immunization in pregnancy provides a promising contribution to globally reducing neonatal and under-five childhood mortality and morbidity. Thorough assessment of benefits and risks for the primarily healthy pregnant women and their unborn babies is required. The GAIA project was formed in response to the call of the World Health Organization for a globally concerted approach to actively monitor the safety of vaccines and immunization in pregnancy programs. GAIA aims to improve the quality of outcome data from clinical vaccine trials in pregnant women with a specific focus on the needs and requirements for safety monitoring in LMIC. In the first year of the project, a large and functional network of experts was created. The first outputs include a guidance document for clinical trials of immunization in pregnancy, a basic data collection guide, ten case definitions of key obstetric and neonatal health outcomes, an ontology of key terms and a map of pertinent disease codes. The GAIA Network is designed as an open and growing forum for professionals sharing the GAIA vision and aim. Based on the initial achievements, tools and services are developed to support investigators and strengthen immunization in pregnancy programs with specific focus on LMIC.

Item Type: Article
Additional Information: © 2016 Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creative-commons.org/licenses/by/4.0/).
Keywords: 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
14 October 2016Published Online
16 January 2016Accepted
Publisher License: Creative Commons: Attribution 4.0
PubMed ID: 27751641
Web of Science ID: WOS:000390514000002
Go to PubMed abstract
URI: http://openaccess.sgul.ac.uk/id/eprint/108542
Publisher's version: https://doi.org/10.1016/j.vaccine.2016.07.006

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