Research Questions • Aim 1 will seek to describe the reporting of the allocation method used to assign study units to treatment group in controlled trials using vaccines directed against infectious disease pathogens or food safety pathogens, and if changes in the prevalence of reporting have occurred post-2010. The rationale for this aim is that allocation approaches are an important aspect of assessing bias in clinical trials; however, as several REFLECT statement checklist items are conditional on random allocation, this information would not be captured by assessing only the REFLECT items. Our working hypothesis is that reporting of the allocation methods has improved; however, reporting will likely still be incomplete.