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Polio End-game Strategies - Poliovirus Type 2 Challenge Study

NCT02189811 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2016-05-03

No results posted yet for this study

Summary

Poliomyelitis eradication has entered its last phase with only three remaining endemic countries, of which Pakistan is one. There hasn't been a case of wild type poliovirus 2 since 1999, and no case of wild type poliovirus 3 since November 2012. However, paralytic polio resulting from circulating strains of Sabin poliovirus type 2 have become a challenge, and reported from several areas with low population immunity to polio, including in Pakistan. This study will provide data to National Immunization Authorities in order to make strategic decisions about their polio vaccination schedules in anticipation of the global tOPV to bOPV switch and will provide data on the proposed responses to type 2 poliovirus outbreaks.

Conditions

  • Poliomyelitis

Interventions

BIOLOGICAL

IPV

IPV at birth, 6, 10, 14 weeks of age and tOPV at 18 and 22 weeks of age

BIOLOGICAL

bOPV

bOPV at birth, 6, 10, 14 weeks and tOPV at 18 and 22 weeks of age

BIOLOGICAL

bOPV and IPV

bOPV till week 10, bOPV+IPV at 14 and tOPV at 18 and 22 weeks of age

BIOLOGICAL

bOPV and IPV and IPV2

bOPV till week 10, bOPV+IPV at 14, tOPV+IPV2 at 18 and tOPV at 22 weeks of age

BIOLOGICAL

tOPV

tOPV till 22 weeks of age

Sponsors & Collaborators

Principal Investigators

  • Ali F Saleem, MBBS,FCPS,MSc · Aga Khan University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
1 Day
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2016-04-30
Completion
2016-05-31

Countries

  • Pakistan

Study Locations

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Entities

Companies

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 NCT02189811 on ClinicalTrials.gov