Status:
UNKNOWN
Comparison of Immunity Following IPV Versus fIPV: a Community Based Randomized Controlled Trial in Pakistan
Lead Sponsor:
Aga Khan University
Collaborating Sponsors:
World Health Organization
Conditions:
Poliovirus Vaccine, Inactivated
Poliomyelitis
Eligibility:
All Genders
14-10 years
Phase:
PHASE4
Brief Summary
This study will be conducted in four low-income areas of Bin Qasim Town Karachi. This will be a community based randomized control trial of 21 months duration. The trial will include four arms; arm A ...
Detailed Description
Background In April 2016, there was globally synchronized switch from tOPV to bivalent OPV (bOPV). The Strategic Advisory Group of Experts on immunization (SAGE) from WHO endorsed the use of IPV in ro...
Eligibility Criteria
Inclusion
- Children aged 14 weeks for arms A and B and 9 months for arms C and D living in four peri-urban slums of Bin Qasim Town, Karachi (Rehri Goth, Bhains Colony, Ali Akber Shah, Ibrahim Hydri) who have not received IPV vaccine during routine immunization for arms A and B and who have documentary evidence of receiving IPV vaccine at 14 weeks of age for arms C and D.
Exclusion
- Child found acutely ill at the time of enrolment and requiring emergent medical care/hospitalization
- Parents planning to shift out of the four communities during the study time (at least 18 months for arms A and B, and 1 year for arms C and D)
- Refusal of blood testing
- Already enrolled in any other clinical trial
Key Trial Info
Start Date :
August 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2019
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT03286803
Start Date
August 1 2017
End Date
June 30 2019
Last Update
January 9 2019
Active Locations (1)
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1
Rehri goth, Ibrahim Hyderi, Ali Akbar Shah, and Bhens Colony
Karachi, Sindh, Pakistan