Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202308820044137 Date of Approval: 10/08/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluating the impact of an Intradermal Needle-free Delivery Device on a Polio Routine Immunization Program
Official scientific title Evaluating the impact of an Intradermal Needle-free Delivery Device on a Polio Routine Immunization Program
Brief summary describing the background and objectives of the trial The mixed methods study will evaluate the impact of intradermal (ID) polio vaccine administration using the Tropis® Needle-free Injection System (NFIS) in Nigeria. The evaluation will measure vaccine coverage and costs of using Tropis ID for fractional inactivated poliovirus vaccine (fIPV) delivery compared with standard intramuscular delivery using standard needles and autodisable syringes. The study will also assess the programmatic feasibility, acceptability, sustainability, and scalability of the introduction of Tropis IPV delivery into the Nigerian Expanded Immunization (EPI) program. The above overall aims will be addressed through three study aims: Aim 1: Assess effectiveness of fIPV Tropis administration compared to standard IPV administration. Aim 2: Assess program costs of implementation from the health system perspective and compare with standard IPV administration. Aim 3: Assess acceptability, feasibility (amongst caregivers and healthcare providers), scalability and sustainability of fIPV using Tropis to achieve scale and sustainability of the intervention.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Polio
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 13/07/2023
Actual trial start date
Anticipated date of last follow up 19/01/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 5200
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
IRB00023625 Bloomberg School of Public Health IRB
NHREC 01 01 2007 National Health Research Ethics Committee of Nigeria
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Tropis Needle free Injection System Twice at 6 and 14 weeks of age In the intervention group, vaccinators at apex facilities in randomly selected wards will be trained in the use of the PharmaJet Tropis device to provide needle-free IPV via the ID route at 6 and 14 weeks of age. The recipients of the intervention will be under-1 children that will be receiving intradermal fIPV during routine immunization days in the 22 selected intervention health facilities (11 per state). 2600
Control Group status quo IPV vaccine administration twice and 6 and 14 weeks Immunization with inactivated poliovirus vaccine in line with the existing standard of care for the government supported vaccination program 2600 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Previously unvaccinated against IPV Aged over 6 weeks Seeking immunization at an outreach or fixed site Previously vaccinated against IPV Aged less than 6 weeks Infant: 1 Month-23 Month 1 Month(s) 13 Month(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 08/05/2023 National Health Research Ethics Committee of Nigeria
Ethics Committee Address
Street address City Postal code Country
Federal Ministry of Health, 11th floor, Federal Secretariat Complex Phase III, Ahmadu Bello Way, Abuja Abuja 900001 Nigeria
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/05/2023 Johns Hopkins School of Public Health Institutional Review Board Office
Ethics Committee Address
Street address City Postal code Country
615 N. Wolfe Street / Room E1100 Baltimore 21218 United States of America
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome percentage of children 3-12 months old who receive two doses of IPV, defined as evidence of vaccination by documented vaccination card or by verbal history One month post-implementation
Secondary Outcome Percentage of children 3-12 months old who receive at least one dose of IPV, defined as evidence of vaccination by documented vaccination card or by verbal history 1 month post-implementation
Secondary Outcome Percentage of caregivers who report acceptability of the Tropis method 1 month post-implementation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Primary Health Care Development Agency Port Harcourt Crescent, Off Gimbiya Street, Area 11, Garki, Abuja, Plot 681/682 Abuja Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
United States Agency for International Development USAID MOAA Office of Acquisition and Assistance 1300 Pennsylvania Avenue NW Washington DC 20523 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor PharmaJet 400 Corporate Circle Suite N Golden 80401 United States of America Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
National Primary Health Care Development Agency Port Harcourt Crescent, Off Gimbiya Street, Area 11, Garki, Abuja, Plot 681/682 Abuja Nigeria
Jhpiego 1615 Thames Street Baltimore 21231 United States of America
PATH 2201 Westlake Ave Ste 200 Seattle 98121 United States of America
Sydani Group 1422 Independence Ave, Central Business Dis Abuja 900103 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Diwakar Mohan dmohan3@jhu.edu +14105024545 Johns Hopkins School of Public Health, Wolfe Street Building
City Postal code Country Position/Affiliation
Baltimore United States of America Assistant Scientist
Role Name Email Phone Street address
Principal Investigator Elizabeth Oliveras elizabeth.oliveras@jhpiego.org +14105371800 1615 Thames Street, Suite 301
City Postal code Country Position/Affiliation
Baltimore 21231 United States of America Director Monitoring Evaluation Research and Learning
Role Name Email Phone Street address
Public Enquiries Paul LaBarre paul.labarre@pharmajet.com +13602289815 400 Corporate Circle Suite N
City Postal code Country Position/Affiliation
Golden 80401 United States of America Vice President of Global Business Development
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported, after deidentification (text, tables, figures, and appendices). This will consist of sociodemographic data and vaccine uptake data collected in baseline and post-vaccination surveys Informed Consent Form,Study Protocol 6 months from end of data collection Application to the principal investigator with a valid scientific proposal to be reviewed at an institutional level.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information