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NCT05663463 · ClinicalTrials.gov registry record · NA
Seasonal Influenza Vaccine High Dose Boosting in Solid Organ Transplant Recipients
A NA study of Solid Organ Transplant, sponsored by University of Minnesota.
- Completed
- Registry status
- NA
- Development phase
- 74
- Enrollment target
- 1
- Study location
NCT05663463: Completed NA study of Solid Organ Transplant, sponsored by University of Minnesota.
NCT05663463 is a NA study of Solid Organ Transplant that has completed, run by University of Minnesota. The registered enrollment target is 74 participants, below the 615-participant average among 4 other Solid Organ Transplant trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05663463, a NA study of Solid Organ Transplant, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- NA
- Development phase
- 74 participants
- Enrollment target
- 1
- Study location
Study Summary
In solid organ transplant (SOT) the receipt of influenza vaccine in an influenza season is associated with decreased disease severity as demonstrated by the presence of pneumonia and ICU admissions. Different strategies have been assessed to optimize vaccine efficacy and immunogenicity of the influenza vaccine in the solid organ transplant recipient (SOTR). The primary objective of the study is to evaluate the immunogenicity of 2 doses of the high dose influenza vaccine utilizing neutralizing antibody assays. A control group receiving 1 HD influenza vaccine will be included.
Primary Outcome
Geometric mean titers and geometric mean fold rise from baseline of homologue neutralizing antibodies in reporter microneutralization will be measured and compared across groups.
Conditions Studied
Interventions
- DRUG Fluzone High-Dose - 2 doses
- DRUG Fluzone High-Dose - 1 dose of HD
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2023-09-11 |
| Est. Completion | 2025-06-16 |
| Phase | NA |
What the finished NCT05663463 record still lists
NCT05663463 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 615-participant average among 4 other Solid Organ Transplant trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Solid Organ Transplant appearing as the primary indexed condition, and to 2 interventions - of which Fluzone High-Dose - 2 doses is the first listed.
NCT05663463 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT05663463 about?
NCT05663463 is a clinical study titled "Seasonal Influenza Vaccine High Dose Boosting in Solid Organ Transplant Recipients". In solid organ transplant (SOT) the receipt of influenza vaccine in an influenza season is associated with decreased disease severity as demonstrated by the presence of pneumonia and ICU admissions. Different strategies have been assessed to optimize vaccine efficacy and immunogenicity of the influe...
What is the current status of trial NCT05663463?
This trial is currently completed. It is a NA study. The enrollment target is 74 participants. The study started on 2023-09-11. Estimated completion is 2025-06-16.
What conditions does trial NCT05663463 study?
This clinical trial studies the following conditions: Solid Organ Transplant.
What interventions are being tested in trial NCT05663463?
The interventions under investigation include: Fluzone High-Dose - 2 doses (DRUG), Fluzone High-Dose - 1 dose of HD (DRUG).
Who is sponsoring clinical trial NCT05663463?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05663463 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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