PolioPhase 4NCT01908114
To Develop, Implement and Evaluate the Polio Demonstration Project Comprising of a Community Based Intervention Package for Polio Eradication in Pakistan
A Phase 4 study testing Enhanced Community mobilization and Combined Oral Polio Vaccine and Inject able Polio Vaccine during SIA in people with Polio and Polio Sero Conversion, run by Aga Khan University at 1 site in Pakistan.
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… Read more about this study
- Who is it for?
- Ages 1 month to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Polio, Polio Sero Conversion, Polio Sero Prevalence
- What is being tested?
- Enhanced Community mobilization and Combined Oral Polio Vaccine and Inject able Polio Vaccine during SIA
- Type of treatment
- Vaccines, Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60,000 participants
- Where
- 1 sitePakistan
- Study dates
- Jul 2013to Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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
- Being tested
- Enhanced Community mobilization, Combined Oral Polio Vaccine and Inject able Polio Vaccine during SIA
- Keywords
- Polio disease, Intervention Package, Polio sero prevalence and sero conversion, Polio high risk areas of Pakistan
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Community mobilizationBehavioural
Combined Oral Polio Vaccine and Inject able Polio Vaccine during SIABiological
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Behavioral: Enhanced Community mobilization; Biological: Combined Oral Polio Vaccine and Inject able Polio Vaccine during SIA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved immunization coverage
Improved coverage in both routine immunization and polio campaign Immunization compared to Baseline
Measured: 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
Population bases Immunity level for polio antibodies will be assessed by
Sero prevalance and conversion at various time points
Measured: 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
Quantification of Polio virus will be assessed in stool samples collected at day 28, day 35 and day 49 after recruitment
Measured: 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
Shedding of Polio virus in stool samples will be assessed at day day 28, day 35 and day 49 after recruitment
Measured: The stool samples will be collected and analysed at day 28, day 35 and day 49 after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2017
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PolioStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 60,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Dr Zulfiqar Ahmed Bhutta, Aga Khan University
- Investigators
- Zulfiqar A Bhutta, PhD, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908114
- Sponsor's protocol ID
- 2432-PED-ERC-12
- Status last verified
- Feb 2021
- First submitted
- 15 Jul 2013
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28495264
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Develop, Implement and Evaluate the Polio Demonstration Project Comprising of a Community Based Intervention Package for Polio Eradication in Pakistan
- ClinicalTrials.gov ID
- NCT01908114
- Acronym / sponsor ID
- 2432-PED-ERC-12
- Keywords
- Polio disease, Intervention Package, Polio sero prevalence and sero conversion, Polio high risk areas of Pakistan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60,000 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- 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
- Study start
- Jul 2013 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Dec 2021 (estimated)
- First posted
- 25 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | No intervention | –Routine Polio Program activities will be carried out with out any active intervention |
| Group B | Experimental | Behavioral: Enhanced Community mobilizationExpanded 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) |
| Group C | Experimental | Behavioral: Enhanced Community mobilization, Biological: Combined Oral Polio Vaccine and Inject able Polio Vaccine during SIAAll Interventions of Group A and B Plus combined bOPV/IPV strategy in the SIAs during the project |
Who may qualify
- Ages
- 1 month to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Community mobilization | Behavioural | Group B, Group C |
| Combined Oral Polio Vaccine and Inject able Polio Vaccine during SIA | Biological | Group C |
Primary outcome
Improved immunization coverage
Time frame: At the completion of all recruitment and follow ups which will take an average time of 1 year
Improved coverage in both routine immunization and polio campaign Immunization compared to Baseline
3 secondary outcomes
Improved Polio Sero prevalence
Time frame: 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
Time frame: 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
Time frame: The stool samples will be collected and analysed at day 28, day 35 and day 49 after recruitment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Derived from this study: PubMed 28495264Habib 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.
Related trials for Polio
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
RecruitingPhase 1
Safety and Immunogenicity of a Recombinant Poliomyelitis Vaccine (rPV) in Comparison With IPOL Vaccine in Healthy Adults
Polio Immunity
Active, not recruiting
Effects of Virtual Walking on Chronic Pain and Psychological Distress for Individuals With Severe Mobility Impairment
Severe Mobility Impairment, Spinal Cord Injuries (SCI)
RecruitingPhase 3
A Study to Evaluate the Mucosal Intestinal Immunity to Poliovirus Type-2 of nOPV2 at Birth Dose in Healthy IPV Vaccinated Infants
Poliomyelitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zulfiqar A Bhutta, PhD principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enhanced Community mobilization and Combined Oral Polio Vaccine and Inject able Polio Vaccine during SIA in people with Polio and Polio Sero Conversion, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved immunization coverage (time frame: At the completion of all recruitment and follow ups which will take an average time of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01908114, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.