Clare L Cutland, Shobna Sawry, Lee Fairlie, Shaun Barnabas, Vera Frajzyngier, Jean Le Roux, Alane Izu, Kebonethebe Emmanuel Kekane-Mochwari, Caroline Vika, Jeanne De Jager, Samantha Munson, Babalwa Jongihlati, James H Stark, Judith Absalon
BACKGROUND: Background epidemiologic population data from low- and middle-income countries (LMIC), on maternal, foetal and neonatal adverse outcomes are limited. We aimed to estimate the incidence of maternal, foetal and neonatal adverse outcomes at South African maternal vaccine trial sites as reported directly in the clinical notes as well as using the 'Global Alignment of Immunization Safety Assessment in Pregnancy' case definitions (GAIA-CDs). GAIA-CDs were utilized as a tool to standardise data collection and outcome assessment, and the applicability and utility of the GAIA-CDs was evaluated in a LMIC observational study...
February 2, 2024: Vaccine