NCT01375647

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 700 (actual)
• Sponsor: University of Vermont · Academic / Other
• Sex: All
• Age: 7 Days
• Healthy volunteers: Accepted

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.

Conditions

• Rotavirus Diarrhea
• Vaccine Virus Shedding
• Tropical Enteropathy

Interventions

Type	Name	Description
BIOLOGICAL	IPV (inactivated polio vaccine)	Administered per protocol
BIOLOGICAL	Rotarix	Administered per protocol

Timeline

• Start date: 2011-05-01
• Primary completion: 2014-10-01
• Completion: 2014-11-01
• First posted: 2011-06-17
• Last updated: 2025-04-29
• Results posted: 2025-04-29

Locations

1 site across 1 country: Bangladesh