NCT03818477

Brief Summary

This study will be used to develop a tool to streamline poliovirus environmental surveillance for the polio endgame and to provide a tool for detecting polio in places where there is no capacity to carry out the gold standard culture-based detection.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

June 9, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

October 3, 2019

Status Verified

October 1, 2019

Enrollment Period

9 months

First QC Date

January 24, 2019

Last Update Submit

October 1, 2019

Conditions

Polio

Outcome Measures

Primary Outcomes (1)

  • Polymerase Chain Reaction (PCR) detection of poliovirus, enteric pathogens and antimicrobial resistance genes from environmental samples

    Evaluate performance of the TaqMan Array Card (TAC) on environmental samples (sewage samples) collected in urban slum area of Mirpur. The primary purpose will be to use TAC to detect and monitor Sabin 1 and 3 polio viruses post SIA.

    through study completion, an average of 1 year

Eligibility Criteria

AgeUp to 4 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

The investigators will conduct a Supplementary Immunization Activity (SIA) using bivalent oral polio vaccine (bOPV) and administer bOPV to at least 70% of all children under the age of 5 in the participating wards in the urban slums of Mirpur, Dhaka

You may qualify if:

  • birth-4 years of age
  • reside in selected urban slums of Mirpur Dhaka, Bangladesh
  • receiving bOPV immunization

You may not qualify if:

  • parent unwilling to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Centre for Diarrhoeal Disease Research

Dhaka, Bangladesh

Location

MeSH Terms

Conditions

Poliomyelitis

Condition Hierarchy (Ancestors)

MyelitisCentral Nervous System InfectionsInfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeuroinflammatory DiseasesNeuromuscular Diseases

Study Officials

  • Mami Taniuchi

    University of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 24, 2019

First Posted

January 28, 2019

Study Start

June 9, 2019

Primary Completion

February 28, 2020

Study Completion

September 1, 2020

Last Updated

October 3, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

BA(1)