NCT01908114

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60,000

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2013

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 25, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

Enrollment Period

4 years

First QC Date

July 15, 2013

Last Update Submit

February 16, 2021

Conditions

PolioPolio Sero ConversionPolio Sero PrevalenceImmunization Coverage

Keywords

Polio diseaseIntervention PackagePolio sero prevalence and sero conversionPolio high risk areas of Pakistan

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Improved Polio Sero prevalence

    The immunity levels will be assessed at the time of recruitment, six weeks after recruitment and 18 weeks after recruitment

  • Quantification of Polio virus in stool samples

    The stool samples will be collected and analysed at day 28, day 35 and day 49 after recruitment

  • Shedding of Polio virus in stool samples

    The stool samples will be collected and analysed at day 28, day 35 and day 49 after recruitment

Study Arms (3)

Group A

NO INTERVENTION

Routine Polio Program activities will be carried out with out any active intervention

Group B

EXPERIMENTAL

Expanded intervention with following components 1. Community support groups for both male and female at village/community level 2. Enhanced communication package and involvement of local social networks for group counseling on promotion of nutrition, hygiene and Expanded Program of Immunization (EPI) vaccinations 3. Involvement of Private sector (General Physicians,health care providers etc.) through advocacy and inclusion in Supplementary Immunization activities (SIAs) 4. Delivery of interventions \& commodities through low cost health camps during National Immunization days (NIDs) and SIAs (will also assist in mop-up campaigns)

Behavioral: Enhanced Community mobilization

Group C

EXPERIMENTAL

All Interventions of Group A and B Plus combined bOPV/IPV strategy in the SIAs during the project

Behavioral: Enhanced Community mobilizationBiological: Combined Oral Polio Vaccine and Inject able Polio Vaccine during SIA

Interventions

Enhanced Community mobilizationBEHAVIORAL
Group BGroup C
Combined Oral Polio Vaccine and Inject able Polio Vaccine during SIABIOLOGICAL
Group C

Eligibility Criteria

Age1 Month - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan University

Karachi, Sindh, Pakistan

Location

Related Publications (1)

  • Habib MA, Soofi S, Cousens S, Anwar S, Haque NU, Ahmed I, Ali N, Tahir R, Bhutta ZA. Community engagement and integrated health and polio immunisation campaigns in conflict-affected areas of Pakistan: a cluster randomised controlled trial. Lancet Glob Health. 2017 Jun;5(6):e593-e603. doi: 10.1016/S2214-109X(17)30184-5.

    PMID: 28495264DERIVED

MeSH Terms

Conditions

Poliomyelitis

Condition Hierarchy (Ancestors)

MyelitisCentral Nervous System InfectionsInfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeuroinflammatory DiseasesNeuromuscular Diseases

Study Officials

  • Zulfiqar A Bhutta, PhD

    Aga Khan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Founding Director, Centre of Excellence in Women and Child Health

Study Record Dates

First Submitted

July 15, 2013

First Posted

July 25, 2013

Study Start

July 1, 2013

Primary Completion

July 1, 2017

Study Completion

December 1, 2021

Last Updated

February 18, 2021

Record last verified: 2021-02

Locations

PA(1)