"Much has been written about the lower point estimates of efficacy in these trials compared with trials performed in higher resource settings. Among the reasons given for the lower efficacy are higher maternal antibody in low-resource settings, environmental enteropathy, differences in the gut microbiome among children in different resource settings, nutritional status, breastfeeding practices and interference by oral poliovirus vaccines    . In addition to these factors, we propose that the contribution of study design differences should be considered when comparing point estimates of efficacy across trials. "
[Show abstract][Hide abstract] ABSTRACT: Oral rotavirus vaccines have yielded different point estimates of efficacy when tested in different populations. While population and environmental factors may account for these differences, study design characteristics should also be considered. We review the study design elements of rotavirus vaccine trials that may affect point estimates of efficacy, and propose a framework for evaluating new rotavirus vaccines.
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