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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 is a Phase 4 study that has completed, run by Inova Health Care Services. The registered enrollment target is 62 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01808456
The ClinicalTrials.gov registry entry for NCT01808456 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Inova Health Care Services, which has 75 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which influenza trivalent inactive vaccine is the first listed.
NCT01808456 reports 0 study locations.
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.
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