Twinrix Pregnancy Registry

The purpose of the Twinrix Pregnancy Registry is to prospectively collect data describing exposure to Twinrix before or during pregnancy, potential confounding factors (such as exposure to other medications) and information related to the outcome of the pregnancy. This is a prospective, voluntary, observational, exposure-registration study. Twinrix is designated as Food and Drug Administration (FDA) Pregnancy Category C, which means that its safety in human pregnancy has not been determined. The Registry is intended to provide an early signal of potential risks in advance of results from formal epidemiologic studies. Registry statistics can supplement animal reproductive toxicology studies and assist clinicians in evaluating the potential risks and benefits of vaccination for individual patients.