ID Administration of fIPV Using Intradermal Adapters vs. BCG Syringe
Condition: IPV
Study type: Interventional

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.
    

Intervention name(s): Westpharma ID adapter; Star ID syringe; BCG NS
Intervention type(s): Device; Device; Device
Intervention description(s): device used for administering intradermal injection; device used for administering intradermal injection; syringe used for administering intradermal injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: WestPharma ID-adapter; Star ID syringe; BCG needle syringe; fractional dose IPV; fIPV; polio; Polio Endgame; IPV