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NCT01808456 · ClinicalTrials.gov registry record · Phase 4
Standard-dose Versus High-dose Flu Vaccine in Solid Organ Transplant.
A Phase 4 study, sponsored by Inova Health Care Services.
- Completed
- Registry status
- Phase 4
- Development phase
- 62
- Enrollment target
NCT01808456: Completed Phase 4 study, sponsored by Inova Health Care Services.
NCT01808456 is a Phase 4 study that has completed, run by Inova Health Care Services. The registered enrollment target is 62 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01808456, a Phase 4 study, has completed, sponsored by Inova Health Care Services.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 62 participants
- Enrollment target
Study Summary
Influenza infection in recipients of solid organ transplants recipients while on maintenance immunosuppressant therapy is associated with increased morbidity and mortality. Although influenza vaccination is recommended in these high-risk patients, safety and immunogenicity of commercially available different strengths of influenza vaccine have not been established. The primary study objective is to determine the safety and immunogenicity of Fluzone and Fluzone High-Dose, with a secondary objective to determine the tolerability and efficacy of two different strengths of trivalent influenza vaccine (TIV, flu vaccine). Both vaccines are commercially available for use in the general population. Fluzone is approved for use in 6 months of age and older, and Fluzone High-Dose is approved for use in 65 years of age and older. This is an exploratory, open-label, parallel group, observer blinded, prospective study. All recipients of kidney, lung, heart transplants who attend for post-transplant follow-up, at least 30-days after transplantation at Inova Fairfax Hospital Transplant Center will be eligible for enrollment. Enrolled patients will be followed for three months (a total of 4 visits) following enrollment and randomization: day 0 (enrollment) and follow-up visits at weeks 1, 4, 8, and 12.
Primary Outcome
Evaluation of local and systemic reactions, use of analgesics or antipyretics.
Interventions
- BIOLOGICAL influenza trivalent inactive vaccine
- BIOLOGICAL influenza trivalent inactive vaccine high dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2013-10 |
| Est. Completion | 2016-12 |
| Phase | Phase 4 |
What the finished NCT01808456 record still lists
NCT01808456 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which influenza trivalent inactive vaccine is the first listed.
NCT01808456 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01808456 about?
NCT01808456 is a clinical study titled "Standard-dose Versus High-dose Flu Vaccine in Solid Organ Transplant.". Influenza infection in recipients of solid organ transplants recipients while on maintenance immunosuppressant therapy is associated with increased morbidity and mortality. Although influenza vaccination is recommended in these high-risk patients, safety and immunogenicity of commercially available ...
What is the current status of trial NCT01808456?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 62 participants. The study started on 2013-10. Estimated completion is 2016-12.
What interventions are being tested in trial NCT01808456?
The interventions under investigation include: influenza trivalent inactive vaccine (BIOLOGICAL), influenza trivalent inactive vaccine high dose (BIOLOGICAL).
Who is sponsoring clinical trial NCT01808456?
This trial is sponsored by Inova Health Care Services, which has 75 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01808456's enrollment target sits among peer trials
62 1110th of 2000 higher than 882 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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