CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 83 enrolled
Drug / intervention
2011-2012 Fluzone trivalent inactivated 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/NCT01644149
NCT01644149Phase 4Completed
CompareCT.gov

A Randomized Controlled Clinical Trial Assessing the Immunologic Response to an FDA-approved Influenza Vaccine Delivered Using an FDA-Cleared Jet Injection Vaccine Delivery Device or a Needle and Syringe

PharmaJet, Inc.·interventional·Posted Jul 18, 2012·Updated Jun 20, 2019

In Brief

A Phase 4 clinical trial evaluating Stratis Jet Injector, Needle and Syringe, and 1 other intervention for Influenza Prophylaxis. Completed, enrolled 83 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza Prophylaxis
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 18, 2012
Enrollment StartJan 1, 2012
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 14.0 years ago

Interventions

Stratis Jet Injectordevice

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

Needle and Syringedevice

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

2011-2012 Fluzone trivalent inactivated influenza vaccinebiological