title: Global alignment of immunization safety assessment in pregnancy - The GAIA project.
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.
authors.affiliation: Brighton Collaboration Foundation, Basel, Switzerland; University of Basel Children's Hospital, Basel, Switzerland. Electronic address: contact@brightoncollaboration.org.
authors.forename: Jan
authors.initials: J
authors.lastname: Bonhoeffer
authors.affiliation: Global Healthcare Consulting, Delhi, India.
authors.forename: Sonali
authors.initials: S
authors.lastname: Kochhar
authors.affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, USA.
authors.forename: Steven
authors.initials: S
authors.lastname: Hirschfeld
authors.affiliation: St George's, University of London, London, UK.
authors.forename: Paul T
authors.initials: PT
authors.lastname: Heath
authors.affiliation: St George's, University of London, London, UK.
authors.forename: Christine E
authors.initials: CE
authors.lastname: Jones
authors.affiliation: Brighton Collaboration Foundation, Basel, Switzerland.
authors.forename: Jorgen
authors.initials: J
authors.lastname: Bauwens
authors.affiliation: Synapse Research Management Partners, Barcelona, Spain.
authors.forename: Ángel
authors.initials: Á
authors.lastname: Honrado
authors.affiliation: University of Basel Children's Hospital, Basel, Switzerland.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Heininger
authors.affiliation: Baylor College of Medicine, Houston, USA.
authors.forename: Flor M
authors.initials: FM
authors.lastname: Muñoz
authors.affiliation: University of Washington, Seattle, USA.
authors.forename: Linda
authors.initials: L
authors.lastname: Eckert
authors.affiliation: Cincinnati Children's Hospital Medical Center, USA.
authors.forename: Mark
authors.initials: M
authors.lastname: Steinhoff
authors.affiliation: Cincinnati Children's Hospital Medical Center, USA.
authors.forename: Steven
authors.initials: S
authors.lastname: Black
authors.affiliation: The Children's Hospital of Philadelphia, PA, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Padula
authors.affiliation: Erasmus University Medical Center, Rotterdam, The Netherlands.
authors.forename: Miriam
authors.initials: M
authors.lastname: Sturkenboom
authors.affiliation: Monash University, Melbourne, Australia.
authors.forename: Jim
authors.initials: J
authors.lastname: Buttery
authors.affiliation: Public Health Agency of Canada, Ottawa, Canada.
authors.forename: Robert
authors.initials: R
authors.lastname: Pless
authors.affiliation: World Health Organization, Geneva, Switzerland.
authors.forename: Patrick
authors.initials: P
authors.lastname: Zuber
mesh_terms: D002986:Clinical Trials as Topic; D005260:Female; D014943:Global Health; D006801:Humans; D007114:Immunization / Q000009:adverse effects*; D011247:Pregnancy; D014612:Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D014944:World Health Organization
chemical_list: D014612:Vaccines