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Immunogenicity of Fluzone High Dose in Immunocompromised Children and Young Adults

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01685372
First Posted: September 14, 2012
Last Update Posted: November 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Colorado Clinical & Translational Sciences Institute
Information provided by (Responsible Party):
University of Colorado, Denver
Results First Submitted: June 30, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Conditions: Solid Organ Transplant Recipient (Liver, Kidney, Heart)
Rheumatologic Disorder
Human Immunodeficiency Virus (HIV)
Bone Marrow Transplant (BMT)
Dialysis
Interventions: Biological: Fluzone High Dose
Biological: Fluzone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study subjects were recruited over two influenza seasons, 2013-2014 and 2014-2015. Subjects were recruited from the Dialysis unit and Rheumatology clinic in 2013-2014 by referral from clinicians. Subjects were recruited by mailed letter to Solid Organ Transplant recipients in 2014-2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In 2013-2014, 4 subjects chose not to enroll after learning more about the study. In 2014-2015, 2 subjects chose not to enroll after learning about the study. All potential subjects met pre-screening criteria. No subjects were excluded from the study by study personnel.

Reporting Groups
  Description
Fluzone High Dose A single-dose of high-dose influenza vaccine was administered to subjects randomized to this arm at T1
Fluzone Standard Dose A single-dose of standard-dose influenza vaccine was administered to subjects randomized to this arm at T1

Participant Flow for 3 periods

Period 1:   Timepoint 1 (T1): Vaccine,1st Blood Draw
    Fluzone High Dose   Fluzone Standard Dose
STARTED   7   9 
COMPLETED   7   9 
NOT COMPLETED   0   0 

Period 2:   Timepoint 2 (T2): 2nd Blood Draw
    Fluzone High Dose   Fluzone Standard Dose
STARTED   7   9 
COMPLETED   7   9 
NOT COMPLETED   0   0 

Period 3:   Timepoint 3 (T3): 3rd Blood Draw
    Fluzone High Dose   Fluzone Standard Dose
STARTED   7   9 
COMPLETED   4   5 
NOT COMPLETED   3   4 
Lost to Follow-up                3                4 



  Baseline Characteristics
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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
Fluzone High Dose

Fluzone High Dose 0.5 mL intramuscularly (IM) given once

Fluzone High Dose: A single-dose of high-dose influenza vaccine will be administered to subjects randomized to this arm

Fluzone Standard Dose

Fluzone 0.5mL IM given once

Fluzone: A single-dose of standard-dose influenza vaccine will be administered to subjects randomized to this arm

Total Total of all reporting groups

Baseline Measures
   Fluzone High Dose   Fluzone Standard Dose   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   9   16 
Age 
[Units: Years]
Median (Full Range)
 15 
 (9 to 18) 
 15 
 (10 to 23) 
 15 
 (9 to 23) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      5  71.4%      5  55.6%      10  62.5% 
Male      2  28.6%      4  44.4%      6  37.5% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      2  28.6%      4  44.4%      6  37.5% 
Not Hispanic or Latino      5  71.4%      5  55.6%      10  62.5% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      1  11.1%      1   6.3% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0% 
White      6  85.7%      8  88.9%      14  87.5% 
More than one race      1  14.3%      0   0.0%      1   6.3% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Cohort 
[Units: Participants]
Count of Participants
     
Dialysis   3   4   7 
Solid organ transplant   4   4   8 
Rheumatoloty   0   1   1 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Episodes of Influenza and Influenza-Like-Illness Reported in High Dose and Standard Dose Vaccination Groups   [ Time Frame: up to 10 months after vaccination ]

2.  Primary:   Number of Subjects Seroprotected at Timepoint 2 in High Dose and Standard Dose Vaccination Groups   [ Time Frame: blood draw at 10-45 days post-vaccination ]

3.  Secondary:   Number of Adverse Events Definitely or Possibly Related to Vaccination Reported Within 14 Days of Vaccination   [ Time Frame: 0-14 days after vaccination ]

4.  Secondary:   Number of Subjects With Seroconversion From T1 to T2 in the High Dose and Standard Dose Vaccine Groups   [ Time Frame: 10-45 days post-vaccination ]

5.  Secondary:   Number of Participants Seroprotected at Timepoint 3 in High Dose and Standard Dose Vaccination Groups   [ Time Frame: at least 5 months post vaccination ]

6.  Secondary:   Change in Disease Status From Vaccination Through June of the Following Year   [ Time Frame: up to 9 months post-vaccination ]

7.  Secondary:   Number of Adverse Events Considered Definitely or Possibly Related to Vaccination Through Sept 30 of the Year Following Vaccination.   [ Time Frame: (1) Date of vaccine through day 30 post-vaccine; (2) Day 31 post-vaccine through September 30 of the year following vaccine ]

8.  Other Pre-specified:   Numbers of Subjects Who Were Both Seroprotected and Who Seroconverted at T2 and T3 After Vaccination   [ Time Frame: (1) T2 measured 14-45 days post-vaccination; (2) T3 measured June 1-Sept 30 post-vaccination (end-of season), following vaccination ]

9.  Other Pre-specified:   Additional Measures of Immunogenicity in High Dose and Standard Dose Vaccinations   [ Time Frame: 10-45 days post-vaccination ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
The number of participants was very low, limiting statistical analysis and limiting the ability to perform any subgroup analysis. Data at T3, were even more limited given loss-to-follow-up.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Donna Curtis, MD, MPH
Organization: University of Colorado School of Medicine
phone: 720-777-6981
e-mail: donna.curtis@childrenscolorado.org



Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01685372     History of Changes
Other Study ID Numbers: 12-0829
First Submitted: August 27, 2012
First Posted: September 14, 2012
Results First Submitted: June 30, 2017
Results First Posted: November 30, 2017
Last Update Posted: November 30, 2017