Beth D. Kirkpatrick|E. Ross Colgate|Josyf C. Mychaleckyj|Rashidul Haque|Dorothy M. Dickson|Marya P. Carmolli|Uma Nayak|Mami Taniuchi|C Naylor|Firdausi Qadri|Z. Jennie|Masud Alam|Mary Claire Walsh|Sean A. Diehl|William A. Petri
The “Performance of Rotavirus and Oral Polio Vaccines in Developing Countries” (PROVIDE) Study: Description of Methods of an Interventional Study Designed to Explore Complex Biologic Problems
University of Virginia|University of Vermont|University of Virginia|University of Vermont|University of Virginia|University of Vermont|University of Virginia|University of Vermont|University of Virginia|University of Vermont|University of Virginia|University of Vermont|University of Virginia|University of Vermont|University of Virginia|University of Vermont|University of Virginia|University of Vermont|University of Virginia|University of Vermont|University of Virginia|University of Vermont|University of Virginia|University of Vermont|University of Virginia|University of Vermont|University of Virginia|University of Vermont|University of Virginia|University of Vermont
oral vaccines appear less effective children developing world proposed biologic reasons include concurrent enteric infections malnutrition breast milk interference environmental enteropathy ee rigorous study design careful data management essential begin understand complex problem assuring research subject safety herein describe methodology lessons learned provide study dhaka bangladesh randomized clinical trial platform evaluated efficacy delayeddose oral rotavirus vaccine well benefit injectable polio vaccine replacing one dose oral polio vaccine rigorous infrastructure supported additional examination hypotheses vaccine underperformance primary secondary efficacy immunogenicity measures rotavirus polio vaccines measured well impact ee additional exploratory variables methods enrollment 2year followup 700 child birth cohort described including core laboratory safety regulatory data management practices intense efforts standardize clinical laboratory data management procedures developing world setting provide clinical trials rigor outcomes although study infrastructure requires extensive time effort allows optimized safety confidence validity data gathered complex developing country settings