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Trial record 2 of 3516 for:    adult stem cell transplants | Interventional Studies

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

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ClinicalTrials.gov Identifier: NCT01215734
Recruitment Status : Completed
First Posted : October 6, 2010
Results First Posted : March 8, 2013
Last Update Posted : March 8, 2013
Sponsor:
Information provided by (Responsible Party):
Natasha Halasa, MD, Vanderbilt-Ingram Cancer Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Condition Adult Stem Cell Hematopoetic Transplant
Interventions Biological: High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV)
Biological: Standard Dose Trivalent Inactivated Flu Vaccine
Enrollment 44
Recruitment Details This phase X, double-blind study was conducted from September 2011 - April 2012.
Pre-assignment Details Forty-seven patients consented to participate in this study, three were determined ineligible.
Arm/Group Title High-Dose Trivalent Inactivated Influenza Vaccine Standard Dose Trivalent Inactivated Flu Vaccine
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Forty adult hematopoetic stem cell transplant recipients at least 6 months post-transplant will receive high dose trivalent influenza vaccine

High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV) : 0.5 ml of HD-TIV on visit 1

Twenty Adult stem cell transplant recipients at least 6 months post-transplant will receive standard dose trivalent influenza vaccine.

Standard Dose Trivalent Inactivated Flu Vaccine : Twenty adult hematopoetic stem cell transplant recipients will receive 0.5 ml standard dose trivalent influenza vaccine on visit 1.

Period Title: Overall Study
Started 29 15
Completed 29 14
Not Completed 0 1
Reason Not Completed
Death             0             1
Arm/Group Title High-Dose Trivalent Inactivated Influenza Vaccine Standard Dose Trivalent Inactivated Flu Vaccine Total
Hide Arm/Group Description

Forty adult hematopoetic stem cell transplant recipients at least 6 months post-transplant will receive high dose trivalent influenza vaccine

High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV) : 0.5 ml of HD-TIV on visit 1

Twenty Adult stem cell transplant recipients at least 6 months post-transplant will receive standard dose trivalent influenza vaccine.

Standard Dose Trivalent Inactivated Flu Vaccine : Twenty adult hematopoetic stem cell transplant recipients will receive 0.5 ml standard dose trivalent influenza vaccine on visit 1.

Total of all reporting groups
Overall Number of Baseline Participants 29 15 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 15 participants 44 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
27
  93.1%
14
  93.3%
41
  93.2%
>=65 years
2
   6.9%
1
   6.7%
3
   6.8%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 15 participants 44 participants
50  (12) 49  (14) 50  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 15 participants 44 participants
Female
11
  37.9%
5
  33.3%
16
  36.4%
Male
18
  62.1%
10
  66.7%
28
  63.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 29 participants 15 participants 44 participants
29 15 44
1.Primary Outcome
Title Patients Experiencing at Least 1 Solicited Local and/or Systemic Adverse Event After High Dose (HD) Trivalent Influenza Vaccine (TIV) or Standard Dose (SD) Trivalent Influenza Vaccine in Adult Hematopoetic Stem Cell Transplant (SCT) Recipients
Hide Description 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.
Time Frame Day of TIV to 7 days after TIV
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Hide Analysis Population Description
Patients who received either the high-dose TIV or the standard dose TIV
Arm/Group Title High-Dose Trivalent Inactivated Influenza Vaccine Standard Dose Trivalent Inactivated Flu Vaccine
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High Dose: Adult hematopoetic stem cell transplant recipients at least 6 months post transplant will receive HD TIV (60 micrograms [µg] per antigen) on visit 1
Standard Dose TIV : Adult hematopoetic stem cell transplant recipients at least 6 months post-transplant will receive SD (15 µg/per antigen) TIV on visit 1.
Overall Number of Participants Analyzed 29 15
Measure Type: Number
Unit of Measure: participants
Local Adverse Events 18 4
Systemic Adverse Events 14 7
2.Secondary Outcome
Title Patients Receiving HD or SD TIV With a 4-fold Rise in Hemagglutination Inhibition (HAI) Titers Relative to Baseline for Each of 3 Influenza Viruses
Hide Description Adult hematopoetic stem cell transplant recipients at least 6 months post-transplant receiving either HD or SD TIV who had blood drawn at pre-vaccination and at 28-42 days post-vaccination and who experienced a 4-fold rise in each of three post-vaccination influenza antibody titers, relative to their baseline titers. Trivalent vaccine is for the H1N1/H3N2/B influenzas. A 4-fold rise in type-specific antibody titer is considered adequate antibody response to the specific influenza virus
Time Frame Before TIV and 28-42 days after TIV
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Hide Analysis Population Description
Patients who received either the high-dose or the standard dose TIV and who had blood drawn for HAI titers before TIV and at 28-42 days after TIV. Data not available for 5 HD and 1 SD patients.
Arm/Group Title High-Dose Trivalent Inactivated Influenza Vaccine Standard Dose Trivalent Inactivated Flu Vaccine
Hide Arm/Group Description:
High Dose: Adult hematopoetic stem cell transplant recipients at least 6 months post transplant will receive HD TIV (60 micrograms [µg] per antigen) on visit 1
Standard Dose TIV : Adult hematopoetic stem cell transplant recipients at least 6 months post-transplant will receive SD (15 µg/per antigen) TIV on visit 1.
Overall Number of Participants Analyzed 24 14
Measure Type: Number
Unit of Measure: participants
H1N1 Influenza 12 5
H3N2 Influenza 10 5
B Influenza 10 6
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title High-Dose Trivalent Inactivated Influenza Vaccine Standard Dose Trivalent Inactivated Flu Vaccine
Hide Arm/Group Description

Forty adult hematopoetic stem cell transplant recipients at least 6 months post transplant will receive high dose trivalent influenza vaccine

High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV) : 0.5 ml of HD-TIV on visit 1

Twenty Adult stem cell transplant recipients at least 6 months post transplant will receive standard dose trivalent influenza vaccine.

Standard Dose Trivalent Inactivated Flu Vaccine : Twenty adult hematopoetic stem cell transplant recipients will receive 0.5 ml standard dose trivalent influenza vaccine on visit 1.

All-Cause Mortality
High-Dose Trivalent Inactivated Influenza Vaccine Standard Dose Trivalent Inactivated Flu Vaccine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
High-Dose Trivalent Inactivated Influenza Vaccine Standard Dose Trivalent Inactivated Flu Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/29 (37.93%)      7/15 (46.67%)    
Blood and lymphatic system disorders     
Anemia  0/29 (0.00%)  0 1/15 (6.67%)  1
febrile neutropenia  0/29 (0.00%)  0 1/15 (6.67%)  1
Cardiac disorders     
chest pain, cardiac  0/29 (0.00%)  0 1/15 (6.67%)  2
heart failure  1/29 (3.45%)  1 0/15 (0.00%)  0
palpitations  0/29 (0.00%)  0 1/15 (6.67%)  1
pericardial effusion  1/29 (3.45%)  2 1/15 (6.67%)  1
Supraventricular tachycardia  1/29 (3.45%)  1 0/15 (0.00%)  0
Gastrointestinal disorders     
abdominal pain  1/29 (3.45%)  1 0/15 (0.00%)  0
diarrhea  1/29 (3.45%)  1 0/15 (0.00%)  0
nausea  2/29 (6.90%)  2 2/15 (13.33%)  2
vomiting  1/29 (3.45%)  1 1/15 (6.67%)  1
rectal abscess  1/29 (3.45%)  1 0/15 (0.00%)  0
General disorders     
fever  1/29 (3.45%)  1 1/15 (6.67%)  1
malaise  1/29 (3.45%)  1 0/15 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis  1/29 (3.45%)  1 0/15 (0.00%)  0
Infections and infestations     
Infections and infestations other  0/29 (0.00%)  0 1/15 (6.67%)  1
Laryngitis  0/29 (0.00%)  0 1/15 (6.67%)  1
Methicillin-resistant Staphylococcus aureus bacteremia  0/29 (0.00%)  0 1/15 (6.67%)  1
Investigations     
Alkaline phosphatase increased  0/29 (0.00%)  0 1/15 (6.67%)  1
Creatinine increased  0/29 (0.00%)  0 1/15 (6.67%)  1
Platelet count decreased  0/29 (0.00%)  0 1/15 (6.67%)  1
weight loss  1/29 (3.45%)  1 0/15 (0.00%)  0
Metabolism and nutrition disorders     
dehydration  0/29 (0.00%)  0 1/15 (6.67%)  1
Hyperglycemia  0/29 (0.00%)  0 1/15 (6.67%)  1
Hyperkalemia  1/29 (3.45%)  1 0/15 (0.00%)  0
Hypoalbuminemia  0/29 (0.00%)  0 1/15 (6.67%)  1
Hypomagnesemia  0/29 (0.00%)  0 1/15 (6.67%)  1
Musculoskeletal and connective tissue disorders     
Planned knee replacement surgery  1/29 (3.45%)  1 0/15 (0.00%)  0
diffuse muscle pain  1/29 (3.45%)  1 0/15 (0.00%)  0
Nervous system disorders     
Chronic inflammatory demyelinating polyneuropathy  1/29 (3.45%)  1 0/15 (0.00%)  0
Presyncope  1/29 (3.45%)  1 0/15 (0.00%)  0
Transient ischemic attacks  1/29 (3.45%)  1 0/15 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury  2/29 (6.90%)  2 2/15 (13.33%)  2
Respiratory, thoracic and mediastinal disorders     
upper respiratory infection  1/29 (3.45%)  1 1/15 (6.67%)  1
cough  1/29 (3.45%)  1 0/15 (0.00%)  0
dyspnea  1/29 (3.45%)  1 2/15 (13.33%)  3
hypoxia  1/29 (3.45%)  1 0/15 (0.00%)  0
pleural effusion  0/29 (0.00%)  0 1/15 (6.67%)  1
respiratory failure  0/29 (0.00%)  0 1/15 (6.67%)  1
bonchitis obliterans  0/29 (0.00%)  0 1/15 (6.67%)  1
wheezing  0/29 (0.00%)  0 1/15 (6.67%)  1
Skin and subcutaneous tissue disorders     
Erythema multiforme  1/29 (3.45%)  1 0/15 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
High-Dose Trivalent Inactivated Influenza Vaccine Standard Dose Trivalent Inactivated Flu Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/29 (17.24%)      5/15 (33.33%)    
Gastrointestinal disorders     
anorexia  2/29 (6.90%)  2 0/15 (0.00%)  0
mucositits oral  0/29 (0.00%)  0 1/15 (6.67%)  1
vomiting  0/29 (0.00%)  0 1/15 (6.67%)  1
General disorders     
edema limbs  0/29 (0.00%)  0 1/15 (6.67%)  1
Hepatobiliary disorders     
hepatobiliary disorders, other  0/29 (0.00%)  0 1/15 (6.67%)  1
Investigations     
investigations, other  2/29 (6.90%)  2 1/15 (6.67%)  1
Metabolism and nutrition disorders     
hypokalemia  0/29 (0.00%)  0 1/15 (6.67%)  1
Respiratory, thoracic and mediastinal disorders     
upper respiratory infection  3/29 (10.34%)  3 1/15 (6.67%)  1
cough  1/29 (3.45%)  1 2/15 (13.33%)  2
nasal congestion  0/29 (0.00%)  0 1/15 (6.67%)  1
wheezing  0/29 (0.00%)  0 1/15 (6.67%)  1
Skin and subcutaneous tissue disorders     
dry skin  0/29 (0.00%)  0 1/15 (6.67%)  1
skin and other subcutaneous disorders-other  0/29 (0.00%)  0 1/15 (6.67%)  1
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Natasha Halasa, Associate Professor of Pediatrics
Organization: Vanderbilt University
Phone: 615-322-3346
Responsible Party: Natasha Halasa, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT01215734     History of Changes
Other Study ID Numbers: VICC BMT 1057
100980 ( Other Identifier: IRB number )
100980 ( Other Identifier: IRB number, no grant for this study )
First Submitted: October 5, 2010
First Posted: October 6, 2010
Results First Submitted: February 4, 2013
Results First Posted: March 8, 2013
Last Update Posted: March 8, 2013