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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 is a Phase 1 study that has completed, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 44 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01215734
The ClinicalTrials.gov registry entry for NCT01215734 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt-Ingram Cancer Center, which has 189 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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