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Vaccine. 2016 Dec 1;34(49):5993-5997. doi: 10.1016/j.vaccine.2016.07.006. Epub 2016 Oct 14.

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

Author information

1
Brighton Collaboration Foundation, Basel, Switzerland; University of Basel Children's Hospital, Basel, Switzerland. Electronic address: contact@brightoncollaboration.org.
2
Global Healthcare Consulting, Delhi, India.
3
Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, USA.
4
St George's, University of London, London, UK.
5
Brighton Collaboration Foundation, Basel, Switzerland.
6
Synapse Research Management Partners, Barcelona, Spain.
7
University of Basel Children's Hospital, Basel, Switzerland.
8
Baylor College of Medicine, Houston, USA.
9
University of Washington, Seattle, USA.
10
Cincinnati Children's Hospital Medical Center, USA.
11
The Children's Hospital of Philadelphia, PA, USA.
12
Erasmus University Medical Center, Rotterdam, The Netherlands.
13
Monash University, Melbourne, Australia.
14
Public Health Agency of Canada, Ottawa, Canada.
15
World Health Organization, Geneva, Switzerland.

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.

PMID:
27751641
DOI:
10.1016/j.vaccine.2016.07.006
[Indexed for MEDLINE]
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