SPEAC has released a new overview video highlighting the Brighton Collaboration’s Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) case definition for preterm birth as an Adverse Event of Special Interest (AESI).
Preterm birth, defined as live birth before 37 completed weeks of gestation, is an important outcome monitored in maternal immunization studies. Standardized case definitions help ensure that events are identified, classified, and reported consistently, supporting the generation of comparable vaccine safety data across clinical trials and post-authorization surveillance.
Developed by the Brighton Collaboration, the GAIA project established standardized case definitions and guidance for assessing obstetric and neonatal outcomes in vaccine safety research.
This overview video covers:
- Definition and classification of preterm birth
- Background rates by region
- Clinical pathways and risk factors
- Gestational age assessment methods
- Brighton GAIA levels of diagnostic certainty
- Standardized data collection and reporting
- Application in vaccine safety studies and surveillance
The video is intended for researchers, clinicians, epidemiologists, pharmacovigilance professionals, and others involved in maternal immunization and vaccine safety research.
