ID Administration of fIPV Using Intradermal Adapters vs. BCG Syringe

NCT ID: NCT02769923

Last Updated: 2017-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-11-30

Brief Summary

The investigators will assess the usability and immune response following fractional dose inactivated polio virus vaccine (fIPV) administration with two novel intradermal adapters (ID adapter by West Pharmaceutical services Inc. and Star Intradermal syringe by Star Syringe Ltd.) and compare the response with the one achieved with fIPV administered with traditional BCG needle syringe.

Detailed Description

The study will be conducted in following two phases.

1. Phase I: Ergonometric evaluation and serology: Phase I is based on community based randomized controlled trial with three arms. List of households with child aged 6-12 months will be retrieved from demographic surveillance system. Train CHWs will visit the household and provide relevant information regarding the study to the parents. The children of the parents who provide written informed consent will be screened for eligibility and enrolled into the study. The children accompanied with parents/guardians will be carried to the primary health center of the Dept. of pediatrics and child health, AKU. Baseline 3ml of blood will be collected by trained study phlebotomist in EDT tubes and will be transported to infectious disease research laboratory (IDRL) at AKU. A sample of 450 children will be randomized using sealed envelopes into one of the three study arms. Arm 1, will receive fIPV using WestPharma device, arm 2 will receive fIPV using Star ID syringe and arm 3 will receive fIPV using BCG syringe. The child will be observed for 30 minutes for any adverse event. The research Assistants will interview the parents to fill the socio-demographic questionnaire and vaccinators will fill ergonometric and injection quality questionnaires. The child will be followed after 28 days (4 weeks) of enrollment and another 3ml of blood will be collected by trained phlebotomist. Details of the visit will be recorded in follow-up questionnaire. Both baseline and endline blood samples will be tested for immune response against polio virus 1,2 and 3.

2. Phase II: Pilot campaign demonstration: In this phase, investigators will conduct a door to door campaign in the high risk community to provide fIPV using either WestPharma device or Star ID syringe or BCG needle syringe. In this campaign, any child less than 5 years of age, living in the study area and whose parents provide verbal consent will receive intradermal injection of fIPV using any of the three devices by the trained research assistants. This will be a one day campaign in coordination with provincial polio emergency operation center (EOC). About 300 children will receive fIPV using any of the three devices.

Conditions

IPV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Arm A

Westpharma ID Adapter

Group Type: ACTIVE_COMPARATOR

Westpharma ID adapter

Intervention Type: DEVICE

device used for administering intradermal injection

Arm B

Star ID syringe

Group Type: ACTIVE_COMPARATOR

Star ID syringe

Intervention Type: DEVICE

device used for administering intradermal injection

Arm C

BCG NS

Group Type: ACTIVE_COMPARATOR

BCG NS

Intervention Type: DEVICE

syringe used for administering intradermal injection

Interventions

Westpharma ID adapter

device used for administering intradermal injection

Intervention Type: DEVICE

Star ID syringe

device used for administering intradermal injection

Intervention Type: DEVICE

BCG NS

syringe used for administering intradermal injection

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Children aged 6-12 months living in four peri-urban slums of Bin Qasim Town, Karachi (Rehri Goth, Bhains Colony, Ali Akber Shah, Ibrahim Hydri).

Exclusion Criteria

• Child found acutely ill at the time of enrolment and requiring emergent medical care/hospitalization.
• Refusal of blood testing.
• Any contraindication for ID injection.
• A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family.

• e.g. several early infant deaths, household member on chemotherapy) will render the newborn ineligible for the study.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

World Health Organization

OTHER

Sponsor Role: collaborator

Aga Khan University

OTHER

Sponsor Role: lead

Responsible Party

Ali Faisal Saleem

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ali F Saleem, FCPS,MSc

Role: PRINCIPAL_INVESTIGATOR

The Aga Khan University, Karachi

Mohammad T Yousafzai, MPH, MSc

Role: PRINCIPAL_INVESTIGATOR

The Aga Khan University, Karachi

Other Identifiers

3519-Ped-ERC-15

Identifier Type: -

Identifier Source: org_study_id