Trials / Completed
CompletedNCT01688921
Jet Injection for Influenza
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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 1,250 (actual)
- Sponsor
- PharmaJet, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | AFLURIA vaccine (2012-2013 formulation) | Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region. |
| DEVICE | Needle-Syringe | |
| DEVICE | Stratis needle-free injection device |
Timeline
- Start date
- 2012-10-01
- Primary completion
- 2013-03-01
- Completion
- 2013-03-01
- First posted
- 2012-09-20
- Last updated
- 2017-11-01
- Results posted
- 2014-10-22
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01688921. Inclusion in this directory is not an endorsement.