drugset / Trial / NCT01215734

Standard vs High-Dose Trivalent Inactivated Flu Vaccine in Adult Hematopoetic Stem Cell Transplant (HSCT) Recipients

NCT01215734

Phase 1 Completed 44 enrolled Vanderbilt-Ingram Cancer Center
RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

Start
2010-10
Primary completion
2012-04
Completion
2012-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Influenza Virus Vaccine Vaccine 0.5 ml
Comparator Standard Dose Trivalent Inactivated Flu Vaccine Vaccine 0.5 ml