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Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in INDIA (PROVIDE)

NCT01571505 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 372

Last updated 2017-08-31

No results posted yet for this study

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 breast milk antibodies, changes in gut microbiota, and genetic susceptibility.The primary Objective of this study is to determine whether decreased vaccine responsiveness to oral poliovirus or rotavirus vaccines is associated with the presence of tropical enteropathy.

Conditions

  • Poliomyelitis
  • Tropical Enteropathy

Interventions

BIOLOGICAL

IPV vaccination

Randomized IPV or OPV to children aged at 39weeks.

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • National Institute of Cholera and Enteric Diseases, India

    collaborator OTHER

  • University of Virginia

    collaborator OTHER

  • University of Vermont

    collaborator OTHER

  • International Vaccine Institute

    lead OTHER

Principal Investigators

  • Ayan Dey, Ph.D · International Vaccine Institute

  • William Petri, M.D · University of Virginia

  • Beth Kirkpatrick, M.D. · University of Vermont

  • Suman Kanungo, M.D. · National Institute of Cholera and Enteric Diseases, India

  • Ranjan K Nandy, M.D. · National Institute of Cholera and Enteric Diseases, India

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
42 Days
Max Age
49 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-01
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01571505 on ClinicalTrials.gov