To Develop, Implement and Evaluate the Polio Demonstration Project Comprising of a Community Based Intervention Package for Polio Eradication in Pakistan

Polio Clinical Trial

Official title:

To Develop, Implement and Evaluate the Polio Demonstration Project Comprising of a Community Based Intervention Package for Polio Eradication in Pakistan

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01908114
• Other study ID #: 2432-PED-ERC-12
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: July 2013
• Est. completion date: December 2021

Study information

• Verified date: February 2021
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the projects is to Develop and implement a Package of interventions that will comprise of an augmented communication and counseling strategy coupled with private sector involvement and a combined Oral Polio Vaccine and Inject able Polio Vaccine approach during the Polio campaigns followed by the evaluation of this project for acceptability, feasibility and effectiveness of the intervention Package.

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 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60000
• Est. completion date: December 2021
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 5 Years

Eligibility

Inclusion Criteria:

• Healthy children aged 1 month to 5 years that reside within the study sites, and do not plan to travel away during entire the study period.

Exclusion Criteria:

• Children with known thrombocytopenia or bleeding disorders; children acutely ill or with signs of acute infection (e.g. fever = 101 F) at the time of NID and a diagnosis or suspicion of immunodeficiency disorder.

Related Conditions & MeSH terms

• Immunization Coverage
• Polio
• Polio Sero Conversion
• Polio Sero Prevalence
• Poliomyelitis

Intervention

Behavioral:
• Enhanced Community mobilization

Biological:
• Combined Oral Polio Vaccine and Inject able Polio Vaccine during SIA

Locations

Country	Name	City	State
Pakistan	Aga Khan University	Karachi	Sindh

Sponsors (8)

Lead Sponsor	Collaborator
Aga Khan University	Bill and Melinda Gates Foundation, National Institutes of Health, Pakistan, Pakistan Ministry of Health, Peshawar Medical College, Trust for Vaccines and Immunization, Pakistan, UNICEF, World Health Organization

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved immunization coverage	Improved coverage in both routine immunization and polio campaign Immunization compared to Baseline	At the completion of all recruitment and follow ups which will take an average time of 1 year
Secondary	Improved Polio Sero prevalence	Population bases Immunity level for polio antibodies will be assessed by; Sero prevalance and conversion at various time points	The immunity levels will be assessed at the time of recruitment, six weeks after recruitment and 18 weeks after recruitment
Secondary	Quantification of Polio virus in stool samples	Quantification of Polio virus will be assessed in stool samples collected at day 28, day 35 and day 49 after recruitment	The stool samples will be collected and analysed at day 28, day 35 and day 49 after recruitment
Secondary	Shedding of Polio virus in stool samples	Shedding of Polio virus in stool samples will be assessed at day day 28, day 35 and day 49 after recruitment	The stool samples will be collected and analysed at day 28, day 35 and day 49 after recruitment