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ID Administration of fIPV Using Intradermal Adapters vs. BCG Syringe

NCT02769923 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2017-09-13

No results posted yet for this study

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.

Conditions

  • IPV

Interventions

DEVICE

Westpharma ID adapter

device used for administering intradermal injection

DEVICE

Star ID syringe

device used for administering intradermal injection

DEVICE

BCG NS

syringe used for administering intradermal injection

Sponsors & Collaborators

Principal Investigators

  • Ali F Saleem, FCPS,MSc · The Aga Khan University, Karachi

  • Mohammad T Yousafzai, MPH, MSc · The Aga Khan University, Karachi

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-06-30
Completion
2016-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02769923 on ClinicalTrials.gov