GAIA 2nd Special Issue
Vaccine. Volume 35, Issue 48, Part A, Pages 6469-6582 (4 December 2017) – Harmonising Immunisation Safety Assessment in Pregnancy – Part II




Case classification tool for clinical trial and program monitoring (ABC-Tool)

The ABC-tool, which can be found on the Brighton Collaboration’s website and is accessible to registered members of the Brighton Collaboration through the Virtual Institute ACADEMY, allows users to apply a Brighton Collaboration case definition on a suspected event in order to determine the diagnostic certainty of a diagnosis (option: “Confirm diagnosis”). Furthermore, the ABC-tool can help users to diagnose a patient with observed signs and symptoms based on the case definitions (option: “Search diagnosis”). Under the option “Analyse database”, for each case within a database which contains listed signs and symptoms analogous to a specific case definition, the respective diagnostic certainty for the selected event can be indicated.

This tool also can contribute to bring about a standardisation in diagnosis and in the understanding of adverse events following vaccinations through its global and fast usability. It serves persons engaged in pharmacovigilance but also physicians, supporting the diagnosis of certain events.

Access to the Brighton Collaboration’s ACADEMY might be subject to an access fee, although this might be  waived for volunteers working onBrighton Collaboration’s projects, such as GAIA.

GAIA Terminology Browser

Part of GAIA’s focus has been the development of common standards, guidance, and tools to strengthen programs of immunization in pregnancy. This work will enhance the science of vaccine research by providing standardized, validated, and objective methods for monitoring safety profiles and benefit-to-risk ratios of vaccines. These terminology sets are maintained and published as part of the NCI Thesaurus (NCIt).

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Cancer Institute Enterprise Vocabulary Services (NCI EVS) have been collaborating with GAIA since 2014, to help develop standard terminology related to Fetal and Neonatal Events, Maternal Events, and Pregnancy Events and Outcomes. This expands on the Pediatric Terminology joint effort, ongoing since 2009, to establish a core library of harmonized pediatric terms that enable clinical investigators to more readily compare and aggregate data across clinical research portfolios. To this end, terminology data and draft standards were developed as part of the National Cancer Institute Thesaurus (NCIt) by experts from the NICHD, NCI EVS, and other participants.

All NCIt content is freely available without restriction and can be found in:

  • GAIA-NCIt terminology files. Description of the different files related to th GAIA terminology browser.
  • GAIA Terminology Browser. The specific subset of terms developed in collaboration with NICHD that focuses on developing common standards, guidance, and tools to strengthen programs of immunization in pregnancy.
GAIA 1st Special Issue
Vaccine. Volume 34, Issue 49, Pages 5991-6110 (1 December 2016) – Harmonising Immunisation Safety Assessment in Pregnancy


Reporting Template for the use of GAIA Outputs

The GAIA outputs are increasingly being utilized in current and forthcoming clinical and observational studies for Immunization in Pregnancy and for studies in the field of Maternal and Child Health. A word-based reporting template for the use of GAIA outputs can be downloaded in the following link.

Any key stakeholder in the field becoming aware of the use of GAIA outputs, is kindly requested to list current/future projects of Immunization in Pregnancy or Maternal and Child Health Studies, further details of the study, which GAIA documents are being used / planned to be used in each project, and any other information if available and email this word document to info@gaia-consortium.net and ct@gaia-consortium.net.

Your help in generating high quality safety data on Immunization in Pregnancy and the field of Maternal and Child Health is invaluable.