CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 700 enrolled
Drug / intervention
IPV (inactivated polio vaccine) +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01375647
NCT01375647Phase 3Completed

Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in Bangladesh

University of Vermont·interventional·Posted Jun 17, 2011·Updated Apr 29, 2025

In Brief

A Phase 3 clinical trial evaluating IPV (inactivated polio vaccine) and Rotarix for Rotavirus Diarrhea and 2 related conditions. Completed, enrolled 700 participants across 1 site.

Detailed Summary

Oral polio and rotavirus vaccines are significantly less effective in children living in the developing world. Tropical enteropathy, which is associated with intestinal inflammation, decreased absorption and increased permeability, may contribute substantially to oral vaccine failure in developing country settings. Other possible causes of oral vaccine underperformance include malnutrition, interference with maternal or breastmilk antibodies, changes in gut microbiota, and genetic susceptibility. Primary Objective: to determine whether tropical enteropathy impairs the efficacy of oral polio and rotavirus vaccines in children in Bangladesh. Secondary Objectives: 1) to determine the impact of an IPV (inactivated polio vaccine) boost on the efficacy of OPV (oral polio vaccine) and 2) to determine the efficacy of Rotarix oral rotavirus vaccine to prevent rotavirus diarrhea The polio and rotavirus randomized clinical trials are embedded as secondary objectives within the exploratory study of tropical enteropathy. The primary and secondary outcome measures are relevant to the randomized clinical trials.

Study Details

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 17, 2011
Enrollment StartMay 1, 2011
Primary CompletionOct 1, 2014
Study CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 15.0 years ago

Interventions

IPV (inactivated polio vaccine)biological

Administered per protocol

Rotarixbiological

Administered per protocol