Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Immunization Coverage
  • Polio
  • Polio Sero Conversion
  • Polio Sero Prevalence
Type
Interventional
Phase
Phase 4
Design
Allocation: RandomizedIntervention Model: Factorial AssignmentMasking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Younger than 15 years
Gender
Both males and females

Description

This particular project has been designed to address the bottlenecks through innovations to address community mobilization and demand creation on one hand and assess the synergistic immune enhancement potential of combining Inject able Polio Vaccine (IPV) and Oral Polio Vaccine (OPV) in at-risk chil...

This particular project has been designed to address the bottlenecks through innovations to address community mobilization and demand creation on one hand and assess the synergistic immune enhancement potential of combining Inject able Polio Vaccine (IPV) and Oral Polio Vaccine (OPV) in at-risk children. This project will be implemented in high risk union councils of Karachi, district Kashmore in Sindh and Bajaur Agency in Federally administered Tribal areas (FATA) This will be a three cell cluster randomized trial to achieve the objectives of the study. The first cell of the study will receive all the routine activities being carried out by the polio program, the second cell will receive an expanded intervention with community support groups, enhanced communication package, education and counseling and involvement of private sector. While the third cell will receive all of the interventions of second cell with a combined OPV IPV approach during the polio immunization campaign through child health camps. We have calculated a total sample size of 120 clusters, 40 clusters per group for each study area i-e 120 for Karachi, 120 for Kashmore and 120 for Bajaur. Polio program in Pakistan has well established and demarcated vaccination areas assigned to a vaccination team, each vaccination area usually covers about 200 children therefore the area of vaccination team will be considered as one cluster in the proposed study. The implementation of the project will be followed by impact assessment activities that will include post vaccination coverage surveys and Immunity assessment activities and Environmental sample collection. A total sample size of 5310 children has been calculated for the immunity studies for seroprevalance and 5130 for stool virus shedding

Tracking Information

NCT #
NCT01908114
Collaborators
  • Pakistan Ministry of Health
  • Trust for Vaccines and Immunization, Pakistan
  • National Institutes of Health, Pakistan
  • Peshawar Medical College
  • World Health Organization
  • UNICEF
  • Bill and Melinda Gates Foundation
Investigators
Principal Investigator: Zulfiqar A Bhutta, PhD Aga Khan University