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Trial record 2 of 3355 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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This phase X, double-blind study was conducted from September 2011 - April 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Forty-seven patients consented to participate in this study, three were determined ineligible.

Reporting Groups
  Description
High-Dose Trivalent Inactivated Influenza Vaccine

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

Standard Dose Trivalent Inactivated Flu Vaccine

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.


Participant Flow:   Overall Study
    High-Dose Trivalent Inactivated Influenza Vaccine   Standard Dose Trivalent Inactivated Flu Vaccine
STARTED   29   15 
COMPLETED   29   14 
NOT COMPLETED   0   1 
Death                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
High-Dose Trivalent Inactivated Influenza Vaccine

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

Standard Dose Trivalent Inactivated Flu Vaccine

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 Total of all reporting groups

Baseline Measures
   High-Dose Trivalent Inactivated Influenza Vaccine   Standard Dose Trivalent Inactivated Flu Vaccine   Total 
Overall Participants Analyzed 
[Units: Participants]
 29   15   44 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   27   14   41 
>=65 years   2   1   3 
Age 
[Units: Years]
Mean (Standard Deviation)
 50  (12)   49  (14)   50  (12) 
Gender 
[Units: Participants]
     
Female   11   5   16 
Male   18   10   28 
Region of Enrollment 
[Units: Participants]
     
United States   29   15   44 


  Outcome Measures

1.  Primary:   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   [ Time Frame: Day of TIV to 7 days after TIV ]

2.  Secondary:   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   [ Time Frame: Before TIV and 28-42 days after TIV ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: natasha.halasa@vanderbilt.edu



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