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NCT01654224 · ClinicalTrials.gov registry record · Phase 4
Randomized Trial of High Dose Influenza Vaccine in Long Term Care Setting
A Phase 4 study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 4
- Development phase
- 205
- Enrollment target
NCT01654224: Completed Phase 4 study, sponsored by University of Pittsburgh.
NCT01654224 is a Phase 4 study that has completed, run by University of Pittsburgh. The registered enrollment target is 205 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01654224, a Phase 4 study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 205 participants
- Enrollment target
Study Summary
The purpose of the study is to compare the performance of two currently available influenza (flu) vaccines. This study will try and determine if the high dose flu vaccine provides protection that is the same or better than that of regular dose flu vaccine. Both the regular dose and the high dose flu vaccines are approved by the FDA for use in older adults.
Primary Outcome
The primary objective of this study is to determine the noninferiority of high- dose inactivated influenza vaccine (HDIV) versus standard dose inactivated influenza vaccine(SDIV)among residents of long term care(LTC)settings.Non-inferiority will be determined by comparing baseline and one month post vaccination HAI and MN titers using non-inferiority analysis.
Interventions
- BIOLOGICAL High Dose Inactivated Influenza Vaccine
- BIOLOGICAL Standard Dose Inactivated Influenza Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 205 participants |
| Start Date | 2011-11 |
| Est. Completion | 2014-06 |
| Phase | Phase 4 |
What the finished NCT01654224 record still lists
NCT01654224 is an interventional study that assigns participants to a tested intervention. The registered 205 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which High Dose Inactivated Influenza Vaccine is the first listed.
NCT01654224 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01654224 about?
NCT01654224 is a clinical study titled "Randomized Trial of High Dose Influenza Vaccine in Long Term Care Setting". The purpose of the study is to compare the performance of two currently available influenza (flu) vaccines. This study will try and determine if the high dose flu vaccine provides protection that is the same or better than that of regular dose flu vaccine. Both the regular dose and the high dose flu...
What is the current status of trial NCT01654224?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 205 participants. The study started on 2011-11. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01654224?
The interventions under investigation include: High Dose Inactivated Influenza Vaccine (BIOLOGICAL), Standard Dose Inactivated Influenza Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01654224?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01654224's enrollment target sits among peer trials
205 402nd of 2000 higher than 1,599 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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