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Clinical Trial Assessing the Immunologic Response to a Influenza Vaccine Delivered Using an Jet Injection Device or a Needle Syringe

NCT01644149 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2019-06-20

Study results available
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Summary

The primary objective of this study was to evaluate if administration of a seasonal flu vaccine using a jet injector device is comparable to traditional needle and syringe delivery for eliciting an immune response. A secondary objective was to compare the safety of the two delivery methods.

Conditions

  • Influenza Prophylaxis

Interventions

DEVICE

Stratis Jet Injector

Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine

DEVICE

Needle and Syringe

Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine

BIOLOGICAL

2011-2012 Fluzone trivalent inactivated influenza vaccine

Sponsors & Collaborators

  • PharmaJet, Inc.

    lead INDUSTRY

Principal Investigators

  • Daniel Perlman, MD, MBA · Bel-Rea Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-02-29
Completion
2012-02-29

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 NCT01644149 on ClinicalTrials.gov