The GAIA project has developed a core set of over 21 globally standardized case definitions of selected key obstetric and neonatal terms, a glossary of enabling terms critical to these obstetric and neonatal case definitions (e.g., an algorithm for determination of gestational age) to support stakeholders using the definitions, guideline documents for the standardized conduct of clinical trials of vaccines in pregnant women (including landscape analysis of regulatory guidance available for immunization in pregnancy from the Food and Drug Administration (FDA), European Medicines Agency (EMA) and International Conference on Harmonization) and guidance on study design and the standardization of data collection etc.
The GAIA outputs are developed based on global consultation of professionals from key regulatory organizations, public health institutes, investigators, vaccine manufacturers and academia to ensure their applicability, usefulness and acceptability especially in LMICs. These have been published in a special issue of Vaccine that can be accessed through the GAIA Outputs page: http://gaia-consortium.net/outputs/.
The GAIA case definitions, study design and data collection guidelines and tools will be applicable in immunization in pregnancy pre-and post-licensure safety and pharmacovigilance surveillance systems and will support enhanced surveillance and collection of safety data that can be consolidated and compared across sites, countries, and programs worldwide. A standardized approach to safety data collection and reporting is likely to improve the acceptability and implementation of immunizations in pregnancy and subsequently help reduce illness and death among pregnant women and young infants globally.