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NCT05663463
Seasonal Influenza Vaccine High Dose Boosting in Solid Organ Transplant Recipients
NA trial testing Fluzone High-Dose - 2 doses in Solid Organ Transplant in 74 participants. Completed in 16 June 2025.
16 June 2025
Quick facts
| Lead sponsor | University of Minnesota |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | prevention |
| Enrollment | 74 |
| Start date | 11 September 2023 |
| Primary completion | 16 June 2025 |
| Estimated completion | 16 June 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Fluzone High-Dose - 2 doses — full drug profile →
- Fluzone High-Dose - 1 dose of HD — full drug profile →
Conditions studied
- Solid Organ Transplant — all drugs for Solid Organ Transplant →
Sponsor
University of Minnesota
Who can join
18 and older, any sex, with Solid Organ Transplant. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05663463
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Solid Organ Transplant
Currently open trials in the same condition.
- NCT05968807 — iParent2Parent Program for Parents of Pediatric Solid Organ Transplant Recipients · NA · recruiting
- NCT04613206 — High vs. Standard Dose Influenza Vaccine in Adult SOT Recipients · Phase 2 · active not recruiting
Other University of Minnesota trials
Trials by the same sponsor.
- NCT02421497 — MRI Technical Development and Applications in Kidney Disease · not yet recruiting
- NCT04100109 — Evaluating the Metabolic Effects of Polylactose: A Novel Prebiotic · NA · withdrawn
- NCT05454306 — Anser Clavicle Pin for Surgical Management of Midshaft Clavicle Fractures · NA · withdrawn
- NCT03192007 — Multi-Parametric MRI for Renal Transplantation · not yet recruiting
- NCT04940533 — Pharmacokinetics of CFTR Modulators in Pregnant Individuals and in Postpartum Breastfeeding Mothers · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05663463 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Minnesota
- Last refreshed: 15 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05663463.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing