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NCT01216332 · ClinicalTrials.gov registry record · Phase 1
Standard Versus High-Dose Trivalent Inactivated Flu Vaccine in Pediatric Acute Lymphoblastic Leukemia Patients
A Phase 1 study, sponsored by Vanderbilt University.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT01216332: Completed Phase 1 study, sponsored by Vanderbilt University.
NCT01216332 is a Phase 1 study that has completed, run by Vanderbilt University. The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01216332, a Phase 1 study, has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
This is a phase I safety and immunogenicity trial comparing high-dose (HD)trivalent inactivated influenza vaccine (TIV) to standard dose (SD) TIV in pediatric patients with Acute Lymphoblastic Leukemia.
Primary Outcome
Number of participants with local reactions after each vaccination
Interventions
- DRUG High-dose trivalent inactivated influenza vaccine
- DRUG Standard dose trivalent inactivated influenza vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2010-10 |
| Est. Completion | 2013-05 |
| Phase | Phase 1 |
What the finished NCT01216332 record still lists
NCT01216332 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 2 interventions - of which High-dose trivalent inactivated influenza vaccine is the first listed.
NCT01216332 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01216332 about?
NCT01216332 is a clinical study titled "Standard Versus High-Dose Trivalent Inactivated Flu Vaccine in Pediatric Acute Lymphoblastic Leukemia Patients". This is a phase I safety and immunogenicity trial comparing high-dose (HD)trivalent inactivated influenza vaccine (TIV) to standard dose (SD) TIV in pediatric patients with Acute Lymphoblastic Leukemia.
What is the current status of trial NCT01216332?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2010-10. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01216332?
The interventions under investigation include: High-dose trivalent inactivated influenza vaccine (DRUG), Standard dose trivalent inactivated influenza vaccine (DRUG).
Who is sponsoring clinical trial NCT01216332?
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 NCT01216332's enrollment target sits among peer trials
50 973rd of 2000 higher than 984 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
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