CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,250 enrolled
Drug / intervention
AFLURIA vaccine (2012-2013 formulation) +2 morebiological
Likely dose
AFLURIA vaccine (2012-2013 formulation) 0.5 mLfrom 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/NCT01688921
NCT01688921Phase 4Completed
CompareCT.gov

Jet Injection for Influenza: A Randomized Controlled Clinical Trial to Demonstrate Non Inferiority of Jet Injection vs. Needle and Syringe for Administration of Trivalent Inactivated Influenza Vaccine

PharmaJet, Inc.·interventional·Posted Sep 20, 2012·Updated Nov 1, 2017

In Brief

A Phase 4 clinical trial evaluating AFLURIA vaccine (2012-2013 formulation), Needle-Syringe, and 1 other intervention for Influenza, Human. Completed, enrolled 1,250 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza, Human
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 20, 2012
Enrollment StartOct 1, 2012
Primary CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 13.8 years ago

Interventions

AFLURIA vaccine (2012-2013 formulation)biological

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

Needle-Syringedevice

Stratis needle-free injection devicedevice