CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 44 enrolled
Drug / intervention
High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV) +1 morebiological
Likely dose
High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV) 0.5 mlfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01215734
NCT01215734Phase 1Completed
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Randomized Double-Blind, Comparison of Standard Dose Trivalent Inactivated Influenza Vaccine Versus High-Dose Trivalent Inactivated Influenza Vaccine in Adult Stem Cell Hematopoetic Transplant Recipients

Vanderbilt-Ingram Cancer Center·interventional·Posted Oct 6, 2010·Updated Mar 8, 2013

In Brief

A Phase 1 clinical trial evaluating High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV) and Standard Dose Trivalent Inactivated Flu Vaccine for Adult Stem Cell Hematopoetic Transplant. Completed, enrolled 44 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdult Stem Cell Hematopoetic Transplant
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 6, 2010
Enrollment StartOct 1, 2010
Primary CompletionApr 1, 2012
Study CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 15.7 years ago

Interventions

High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV)biological

0.5 ml of HD-TIV on visit 1

Standard Dose Trivalent Inactivated Flu Vaccinebiological

Twenty adult hematopoetic stem cell transplant recipients will receive 0.5 ml standard dose trivalent influenza vaccine on visit 1.