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Safety Study of Seasonal Influenza Vaccine by Jet Injection

NCT00987350 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-05-03

No results posted yet for this study

Summary

This research study involves testing of a device that can give injections (shots) without the use of a needle.

Conditions

  • Healthy Adults

Interventions

DEVICE

LectraJet

LectraJet is a new jet injector studied for the first time in humans. It is in the category known as disposable-syringe jet injectors that have the advantage of eliminating the risk of disease transmission between subjects. A new syringe and nozzle is used for each patient so that no splash back of blood can occur onto the jet apparatus itself.

DEVICE

TIV by jet injection

Administration of seasonal trivalent influenza vaccine (TIV) by jet injection

BIOLOGICAL

Seasonal Trivalent Influenza Vaccine

Licensed trivalent influenza vaccine provided by either jet injection or traditional needle and syringe.

Sponsors & Collaborators

  • D'Antonio Consultants International, Inc.

    collaborator OTHER

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Jakub K Simon, MD, MS · University of Maryland, College Park

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-05-31
Completion
2010-05-31

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 NCT00987350 on ClinicalTrials.gov