Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01525004 · ClinicalTrials.gov registry record · Phase 1
Standard Dose Versus High-Dose Inactivated Flu Vaccine in Pediatric Solid Organ Transplant Patients
A Phase 1 study, sponsored by Vanderbilt University.
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
NCT01525004: Completed Phase 1 study, sponsored by Vanderbilt University.
NCT01525004 is a Phase 1 study that has completed, run by Vanderbilt University. The registered enrollment target is 38 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01525004, a Phase 1 study, has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
Study Summary
This is a phase I trial in which the both the safety and immunogenicity of the standard dose flu vaccine will be compared with high dose flu vaccine in children that have undergone solid organ transplantation (SOT).
Primary Outcome
We will record local and systemic reactions after each vaccination for seven days. Patients will fill out a diary card. We will collect adverse events for 28 days and SAE for 6 months.
Interventions
- DRUG Standard dose trivalent inactivated influenza vaccine
- DRUG High-Dose trivalent inactivated influenza vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2011-09 |
| Est. Completion | 2012-12 |
| Phase | Phase 1 |
What the finished NCT01525004 record still lists
NCT01525004 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard dose trivalent inactivated influenza vaccine is the first listed.
NCT01525004 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01525004 about?
NCT01525004 is a clinical study titled "Standard Dose Versus High-Dose Inactivated Flu Vaccine in Pediatric Solid Organ Transplant Patients". This is a phase I trial in which the both the safety and immunogenicity of the standard dose flu vaccine will be compared with high dose flu vaccine in children that have undergone solid organ transplantation (SOT).
What is the current status of trial NCT01525004?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2011-09. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01525004?
The interventions under investigation include: Standard dose trivalent inactivated influenza vaccine (DRUG), High-Dose trivalent inactivated influenza vaccine (DRUG).
Who is sponsoring clinical trial NCT01525004?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01525004's enrollment target sits among peer trials
38 1197th of 2000 higher than 797 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01684904 · 38 participants · NA
Proton Therapy for Esophageal Cancer
- NCT03310879 · 38 participants · Phase 2
Study of the CDK4/6 Inhibitor Abemaciclib in Solid Tumors Harboring Genetic Alterations in Genes Encoding D-Type Cyclins or Amplification of CDK4 or CDK6
- NCT03896269 · 38 participants · Phase 1
CPX-351 in Treating Patients With Relapsed or Refractory High Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
- NCT04085315 · 38 participants · Phase 1
Alisertib in Combination With Osimertinib in Metastatic EGFR-mutant Lung Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia