CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
Seasonal Trivalent Influenza Vaccine +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00987350
NCT00987350Phase 4Completed
CompareCT.gov

A Clinical Study to Assess the Safety, Tolerability, and Immunogenicity of Licensed Seasonal Trivalent Influenza Vaccine Administered by Needle-free Jet Injection in One Intramuscular Dose to Healthy Young Adults

University of Maryland, Baltimore·interventional·Posted Sep 30, 2009·Updated May 3, 2021

In Brief

A Phase 4 clinical trial evaluating LectraJet, TIV by jet injection, and 1 other intervention for Healthy Adults. Completed, enrolled 60 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Adults
CountriesUnited States
CollaboratorsD'Antonio Consultants International, Inc.

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 30, 2009
Enrollment StartJan 1, 2010
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 16.8 years ago

Interventions

LectraJetdevice

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.

TIV by jet injectiondevice

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

Seasonal Trivalent Influenza Vaccinebiological

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