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NCT01688921 · ClinicalTrials.gov registry record · Phase 4
Jet Injection for Influenza
A Phase 4 study, sponsored by PharmaJet.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,250
- Enrollment target
NCT01688921: Completed Phase 4 study, sponsored by PharmaJet.
NCT01688921 is a Phase 4 study that has completed, run by PharmaJet. The registered enrollment target is 1,250 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (141% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01688921, a Phase 4 study, has completed, sponsored by PharmaJet.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,250 participants
- Enrollment target
Study 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.
Primary Outcome
The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for A/H1N1 antigen will not exceed 1.5 fold.
Interventions
- BIOLOGICAL AFLURIA vaccine (2012-2013 formulation)
- DEVICE Needle-Syringe
- DEVICE Stratis needle-free injection device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,250 participants |
| Start Date | 2012-10 |
| Est. Completion | 2013-03 |
| Phase | Phase 4 |
What the finished NCT01688921 record still lists
NCT01688921 is an interventional study that assigns participants to a tested intervention. Its 1,250 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (141% higher).
The record links to 0 conditions, and to 3 interventions - of which AFLURIA vaccine (2012-2013 formulation) is the first listed.
NCT01688921 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01688921 about?
NCT01688921 is a clinical study titled "Jet Injection for Influenza". 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.
What is the current status of trial NCT01688921?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,250 participants. The study started on 2012-10. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01688921?
The interventions under investigation include: AFLURIA vaccine (2012-2013 formulation) (BIOLOGICAL), Needle-Syringe (DEVICE), Stratis needle-free injection device (DEVICE).
Who is sponsoring clinical trial NCT01688921?
This trial is sponsored by PharmaJet, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01688921's enrollment target sits among peer trials
1,250 62nd of 2000 higher than 1,939 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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