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Jet Injection for Influenza

NCT01688921 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1250

Last updated 2017-11-01

Study results available
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Summary

The purpose of this study is to determine if the administration of a seasonal flu vaccine using a PharmaJet's needle-free injection device (STRATIS) is equivalent to needle and syringe administration, as measured by laboratory tests of immune response.

Conditions

  • Influenza, Human

Interventions

BIOLOGICAL

AFLURIA vaccine (2012-2013 formulation)

Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.

DEVICE

Needle-Syringe

DEVICE

Stratis needle-free injection device

Sponsors & Collaborators

  • PharmaJet, Inc.

    lead INDUSTRY

Principal Investigators

  • David K Cobb, MD, MPH · Rocky Mountain Infectious Disease Consultants

  • Linda McAllister, MD, PhD · PharmaJet, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United States

Study Locations

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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 NCT01688921 on ClinicalTrials.gov