Status:
COMPLETED
Polio End-game Strategies - Poliovirus Type 2 Challenge Study
Lead Sponsor:
Aga Khan University
Collaborating Sponsors:
World Health Organization
Centers for Disease Control and Prevention
Conditions:
Poliomyelitis
Eligibility:
All Genders
Up to 1 years
Phase:
PHASE4
Brief 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 o...
Detailed Description
The "Polio Endgame Strategy" consists of set of tasks and activities that will be implemented in the next five years. It includes gradual withdrawal of the widely used oral poliomyelitis vaccine (OPV)...
Eligibility Criteria
Inclusion
- Newborn of either gender born healthy with birth weight 2.0 kg or more, with immediate cry, at the study sites (home or health facility births)
- Not planning to travel away during entire the study period (birth-154 days; birth 22 weeks).
- Parents resident of the study area for last 3 month at the time of enrolment
- Parent/guardian provides informed consent
Exclusion
- Newborns found acutely ill at the time of enrolment and requiring emergent medical care/hospitalization, birth weight below 2.0 kg, cry \>2 minutes after birth, or family is planning to be absent during the birth - 154 days study period
- Refusal of blood testing and cord blood testing
- Receipt of OPV after birth before eligibility screen
- Newborns with certain medical conditions i.e., syndromic infants, neonate with petechial or purpura (contraindication of intramuscular injections)
- A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family - e.g. several early infant deaths, household member on chemotherapy) will render the newborn ineligible for the study.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT02189811
Start Date
September 1 2014
End Date
May 1 2016
Last Update
May 3 2016
Active Locations (1)
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1
Rehri goth, Ibrahim Hyderi, Ali Akbar Shah, and Bhens Colony
Karachi, Sindh, Pakistan