Immunogenicity of Fluzone HD,A High Dose Influenza Vaccine, In Children With Cancer or HIV

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT01205581
First received: September 17, 2010
Last updated: September 5, 2014
Last verified: July 2014
Results First Received: July 24, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: HIV
Cancer
Interventions: Biological: Fluzone High Dose Vaccine
Biological: Fluzone Standard Dose Vaccine

  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
Participants were ≥3-21 yrs. at study entry with diagnosis of cancer or HIV. Those with cancer were receiving chemotherapy and/or radiotherapy or had received chemotherapy in the prior 12 weeks. One participant was enrolled but was lost to follow up prior to randomization. 84 participants were randomized between 9/2010 and 10/2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants excluded if they had: pre-vaccination titer of ≥1:2560, severe hypersensitivity to egg proteins or any component of Fluzone, life-threatening reaction after prior influenza vaccine, history of Guillain-Barre syndrome in subject/subject's family, or unwilling to agree to acceptable birth control for 3 months after each dose.

Reporting Groups
  Description
Leukemia-HD Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
Leukemia-SD Patients with a diagnosis of leukemia who received the standard dose Fluzone.
Solid Tumor-HD Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.
Solid Tumor-SD Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
HIV-HD Patients with a diagnosis of HIV who received the high dose Fluzone HD.
HIV-SD Patients with a diagnosis of HIV who received the standard dose Fluzone.

Participant Flow:   Overall Study
    Leukemia-HD     Leukemia-SD     Solid Tumor-HD     Solid Tumor-SD     HIV-HD     HIV-SD  
STARTED     14     13     8     9     20     20  
COMPLETED     13     13     8     9     20     20  
NOT COMPLETED     1     0     0     0     0     0  
Withdrawal by Subject                 1                 0                 0                 0                 0                 0  



  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.
This was an open-label study where participants were randomized at a 1:1 ratio into Fluzone high-dose (HD) and Fluzone standard dose (SD) groups by disease group with the use of a computer-generated randomization schedule.

Reporting Groups
  Description
Leukemia-HD Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
Leukemia-SD Patients with a diagnosis of leukemia who received the standard dose Fluzone.
Solid Tumor-HD Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.
Solid Tumor-SD Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
HIV-HD Patients with a diagnosis of HIV who received the high dose Fluzone HD.
HIV-SD Patients with a diagnosis of HIV who received the standard dose Fluzone.
Total Total of all reporting groups

Baseline Measures
    Leukemia-HD     Leukemia-SD     Solid Tumor-HD     Solid Tumor-SD     HIV-HD     HIV-SD     Total  
Number of Participants  
[units: participants]
  13     13     8     9     20     20     83  
Age  
[units: years]
Mean ± Standard Deviation
  10.8  ± 5.7     11.8  ± 5.1     12.4  ± 4.2     11.7  ± 4.5     16.7  ± 5.6     18.9  ± 4.7     14.6  ± 5.9  
Gender  
[units: participants]
             
Female     4     5     4     4     7     4     28  
Male     9     8     4     5     13     16     55  



  Outcome Measures
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1.  Primary:   Rate of Seroconversion After 1 Dose of Vaccine   [ Time Frame: at least 21 days after first dose, which is given at the time of baseline evaluation visit, and prior to second dose ]

2.  Primary:   Rate of Seroprotection After 1 Dose of Vaccine   [ Time Frame: at least 21 days after first dose, which is given at the time of baseline evaluation visit, and prior to second dose ]

3.  Primary:   Rate of Seroprotection After Last Dose of Vaccine   [ Time Frame: 21 to 42 days after last dose ]

4.  Secondary:   Number of Participants Reporting Grade 3 and Grade 4 Adverse Events Possibly, Probably, or Definitely Attributable to Fluzone or Fluzone HD   [ Time Frame: From initial vaccine administration through up to 8 months ]

5.  Secondary:   Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone HD   [ Time Frame: at least 21 days after each dose of vaccine ]

6.  Secondary:   Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone SD   [ Time Frame: at least 21 days after each dose of vaccine ]

7.  Secondary:   Rate of Vaccine Response by Seroconversion Compared by Absolute Lymphocyte Count (ALC)   [ Time Frame: ALC at baseline and vaccine response at least 21 days after last dose of vaccine ]

8.  Secondary:   Rate of Vaccine Response by Seroprotection Compared by Absolute Lymphocyte Count (ALC)   [ Time Frame: ALC at baseline and vaccine response at least 21 days after last dose of vaccine ]

9.  Secondary:   Number of Local Reactogenicity Events After First Dose   [ Time Frame: First 14 days after vaccination ]

10.  Secondary:   Number of Local Reactogenicity Events After Second Dose   [ Time Frame: First 14 days after vaccination ]

11.  Secondary:   Number of Systemic Reactogenicity Events After First Dose   [ Time Frame: First 14 days after vaccination ]

12.  Secondary:   Number of Systemic Reactogenicity Events After Second Dose   [ Time Frame: First 14 days after vaccination ]

13.  Secondary:   Comparison of Geometric Mean Titer (GMT) by HAI   [ Time Frame: Pre-vaccination, post-vaccination and 9 months after vaccination ]

14.  Secondary:   Comparison of Geometric Mean Ratios (GMR) by HAI   [ Time Frame: Pre-vaccination, post-vaccination and 9 months after vaccination ]


  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
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  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: Jon McCullers, MD
Organization: St. Jude Children's Research Hospital
phone: 866-278-5833
e-mail: info@stjude.org


No publications provided


Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01205581     History of Changes
Other Study ID Numbers: FLUHD
Study First Received: September 17, 2010
Results First Received: July 24, 2014
Last Updated: September 5, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board