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NCT01215734 · ClinicalTrials.gov registry record · Phase 1
Standard vs High-Dose Trivalent Inactivated Flu Vaccine in Adult Hematopoetic Stem Cell Transplant (HSCT) Recipients
A Phase 1 study, sponsored by Vanderbilt-Ingram Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
NCT01215734: Completed Phase 1 study, sponsored by Vanderbilt-Ingram Cancer Center.
NCT01215734 is a Phase 1 study that has completed, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 44 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01215734, a Phase 1 study, has completed, sponsored by Vanderbilt-Ingram Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
Study Summary
Hypothesis 1: The safety profile in adult allogeneic stem cell hematopoietic transplant (SCT) recipients after high dose (HD) trivalent inactivated influenza vaccine (TIV) will not be significantly different from adult stem cell transplant recipients receiving standard dose (SD) TIV. * Specific Aim 1: To compare safety profile of high dose trivalent inactivated influenza vaccine to standard dose trivalent inactivated influenza vaccine in adult hematopoietic stem cell transplant recipients. Hypothesis 2: Adult stem cell transplant recipients who received the higher dose trivalent influenza vaccine will have a greater frequency of (at least a 4-fold) rise in antibody titers to influenza antigens compared to those who receive standard dose trivalent influenza vaccine. * Specific Aim 2: To compare humoral immune responses of adult hematopoietic stem cell transplant recipients influenza virus antigens included in trivalent influenza vaccine after high dose or standard dose trivalent influenza vaccine.
Primary Outcome
Patients were questioned about the following adverse events related to TIV: Local: pain, tenderness, swelling/induration, or erythema at injection site. Systemic: fatigue/malaise, headache, nausea, vomiting, body ache not at injection site, fever \>= 100.4 degrees Fahrenheit, or change in activity level.
Interventions
- BIOLOGICAL High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV)
- BIOLOGICAL Standard Dose Trivalent Inactivated Flu Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2010-10 |
| Est. Completion | 2012-09 |
| Phase | Phase 1 |
What the finished NCT01215734 record still lists
NCT01215734 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 2 interventions - of which High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV) is the first listed.
NCT01215734 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01215734 about?
NCT01215734 is a clinical study titled "Standard vs High-Dose Trivalent Inactivated Flu Vaccine in Adult Hematopoetic Stem Cell Transplant (HSCT) Recipients". Hypothesis 1: The safety profile in adult allogeneic stem cell hematopoietic transplant (SCT) recipients after high dose (HD) trivalent inactivated influenza vaccine (TIV) will not be significantly different from adult stem cell transplant recipients receiving standard dose (SD) TIV. * Specific Aim...
What is the current status of trial NCT01215734?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2010-10. Estimated completion is 2012-09.
What interventions are being tested in trial NCT01215734?
The interventions under investigation include: High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV) (BIOLOGICAL), Standard Dose Trivalent Inactivated Flu Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01215734?
This trial is sponsored by Vanderbilt-Ingram Cancer Center, which has 189 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01215734's enrollment target sits among peer trials
44 1086th of 2000 higher than 901 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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