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NCT01644149 · ClinicalTrials.gov registry record · Phase 4
Clinical Trial Assessing the Immunologic Response to a Influenza Vaccine Delivered Using an Jet Injection Device or a Needle Syringe
A Phase 4 study of Influenza Prophylaxis, sponsored by PharmaJet.
- Completed
- Registry status
- Phase 4
- Development phase
- 83
- Enrollment target
- 1
- Study location
NCT01644149: Completed Phase 4 study of Influenza Prophylaxis, sponsored by PharmaJet.
NCT01644149 is a Phase 4 study of Influenza Prophylaxis that has completed, run by PharmaJet. The registered enrollment target is 83 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01644149, a Phase 4 study of Influenza Prophylaxis, has completed, sponsored by PharmaJet.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 83 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio (GMT with Needle-Free / GMT with Needle and Syringe) antigen will not exceed 1.5 fold.
Conditions Studied
Interventions
- DEVICE Stratis Jet Injector
- DEVICE Needle and Syringe
- BIOLOGICAL 2011-2012 Fluzone trivalent inactivated influenza vaccine
Study Locations (1)
Colorado
- Bel-Rea Institute - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2012-01 |
| Est. Completion | 2012-02 |
| Phase | Phase 4 |
What the finished NCT01644149 record still lists
NCT01644149 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Influenza Prophylaxis appearing as the primary indexed condition, and to 3 interventions - of which Stratis Jet Injector is the first listed.
NCT01644149 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT01644149 about?
NCT01644149 is a clinical study titled "Clinical Trial Assessing the Immunologic Response to a Influenza Vaccine Delivered Using an Jet Injection Device or a Needle Syringe". 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.
What is the current status of trial NCT01644149?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 83 participants. The study started on 2012-01. Estimated completion is 2012-02.
What conditions does trial NCT01644149 study?
This clinical trial studies the following conditions: Influenza Prophylaxis.
What interventions are being tested in trial NCT01644149?
The interventions under investigation include: Stratis Jet Injector (DEVICE), Needle and Syringe (DEVICE), 2011-2012 Fluzone trivalent inactivated influenza vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01644149?
This trial is sponsored by PharmaJet, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01644149 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01644149's enrollment target sits among peer trials
83 937th of 2000 higher than 1,062 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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