Background rates of maternal, fetal, neonatal, and infant outcomes and events of interest to inform maternal immunization clinical trials

GlaxoSmithKline Vaccines is currently preparing for clinical trials that evaluate the safety/reactogenicity and immunogenicity of a respiratory syncytial virus maternal vaccine candidate in pregnant women. Robust epidemiological data is needed to support the interpretation of maternal and neonatal outcomes in pregnant women who receive the investigational vaccine or placebo/control. We plan to conduct an observational study to estimate the rate of select maternal, fetal, and neonatal outcomes and AESIs. The aim of this study is to estimate rates of select maternal, fetal, and neonatal outcomes and adverse events in both the general population and a low-risk population that simulates the clinical trial cohort. This will provide context for interpreting maternal and neonatal outcomes in the low-risk population of pregnant women who will participate in upcoming clinical trials, and will also allow for comparison with maternal and neonatal outcomes in the general population.

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