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Translating randomized controlled trial data to an external target population: a secondary analysis of data from the RV1 trial in South Africa and Malawi








Translating randomized controlled trial data to an external target population: a secondary analysis of data from the RV1 trial in South Africa and Malawi


Denise St. Jean


University of North Carolina at Chapel Hill, Department of Epidemiology






14 January 2021


Although the burden of rotavirus has steadily declined over the past decade, rotavirus continues to be a leading cause of acute gastroenteritis among children younger than five years. Annually, rotavirus accounts for about 258 million diarrhea episodes and 128,500 deaths. However, low-and-middle- income countries (LMIC) experience a disproportionate amount of the world's rotavirus infections compared to high-income settings.As new vaccines move down the pipeline it is increasingly important that estimates from vaccine trials are transportable to external target populations. While randomized controlled trials (RCTs) are popularly considered the “gold standard” for verifying the safety and efficacy of disease interventions, they suffer from a lack of external validity and may not be applicable to real-world populations or alternate settings that may utilize the intervention.The aim of this study to utilize propensity score methods to transport Rotarix vaccine efficacy estimate from the South Africa and Malawi trials to a target population of all eligible children in Malawi using the 2015/6 Malawi Demographic and Health Survey data to represent a random sample of our target population.A peer reviewed publication will be submitted summarizing the results. As additional rotavirus vaccines and other oral vaccines move down the pipeline, ministries of health can greatly benefit from this research when considering their vaccination implementation strategy.



[{ "PostingID": 1296, "Title": "GSK-102248", "Description": "Multi-Center Study to Assess the Efficacy, Safety and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine Given Concomitantly With Routine EPI Vaccinations in Healthy Infants" },{ "PostingID": 1297, "Title": "GSK-111274", "Description": "Multi-Center Study to Assess the Efficacy, Safety and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine Given Concomitantly With Routine EPI Vaccinations in Healthy Infants" }]

Statistical Analysis Plan