Immunogenicity of Fluzone HD,A High Dose Influenza Vaccine, In Children With Cancer or HIV
NCT ID: NCT01205581
Last Updated: 2016-09-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
85 participants
INTERVENTIONAL
2010-09-30
2013-08-31
Brief Summary
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Detailed Description
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The secondary objectives of this study are to:
* Describe the safety and reactogenicity of high-dose and standard-dose TIV.
* Compare the immunogenicity induced by 1 dose, compared to 2 doses, of high-dose and standard-dose TIV.
* Describe the relationship between baseline lymphocyte numbers/function and robustness/durability of the immune response.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Leukemia-HD
Subjects with a diagnosis of leukemia will be vaccinated twice with Fluzone High Dose Vaccine and evaluated for development of immune responses.
Fluzone High Dose Vaccine
Two doses of Fluzone HD will be administered to children with leukemia, solid tumor, or HIV.
Leukemia-SD
Subjects with a diagnosis of leukemia will be vaccinated twice with Fluzone Standard Dose Vaccine and evaluated for development of immune responses.
Fluzone Standard Dose Vaccine
Two doses of Fluzone Standard Dose Vaccine will be administered to children with leukemia, solid tumor, or HIV.
Solid Tumor-HD
Subjects with a diagnosis of solid tumor will be vaccinated twice with Fluzone High Dose Vaccine and evaluated for development of immune responses.
Fluzone High Dose Vaccine
Two doses of Fluzone HD will be administered to children with leukemia, solid tumor, or HIV.
Solid Tumor-SD
Subjects with a diagnosis of solid tumor will be vaccinated twice with Fluzone Standard Dose Vaccine and evaluated for development of immune responses.
Fluzone Standard Dose Vaccine
Two doses of Fluzone Standard Dose Vaccine will be administered to children with leukemia, solid tumor, or HIV.
HIV-HD
Subjects with a diagnosis of human immunodeficiency virus (HIV) will be vaccinated twice with Fluzone High Dose Vaccine and evaluated for development of immune responses.
Fluzone High Dose Vaccine
Two doses of Fluzone HD will be administered to children with leukemia, solid tumor, or HIV.
HIV-SD
Subjects with a diagnosis of human immunodeficiency virus (HIV) will be vaccinated twice with Fluzone Standard Dose Vaccine and evaluated for development of immune responses.
Fluzone Standard Dose Vaccine
Two doses of Fluzone Standard Dose Vaccine will be administered to children with leukemia, solid tumor, or HIV.
Interventions
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Fluzone High Dose Vaccine
Two doses of Fluzone HD will be administered to children with leukemia, solid tumor, or HIV.
Fluzone Standard Dose Vaccine
Two doses of Fluzone Standard Dose Vaccine will be administered to children with leukemia, solid tumor, or HIV.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Written informed consent (and assent, if applicable) obtained.
* Participant has a diagnosis of cancer or HIV.
* If subject has cancer, currently receiving chemotherapy and /or radiotherapy for the treatment of cancer or has received chemotherapy in the past 12 weeks
Exclusion Criteria
* History of Guillain-Barre´ syndrome in the subject or subject's family (parents, siblings, half siblings, or children);
* Not willing to agree to acceptable birth control for three months after study immunization
3 Years
21 Years
ALL
No
Sponsors
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St. Jude Children's Research Hospital
OTHER
Responsible Party
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Principal Investigators
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Jonathan A McCullers, MD
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
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St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
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Related Links
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St. Jude Children's Research Hospital
Clinical Trials Open at St. Jude
Other Identifiers
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FLUHD
Identifier Type: -
Identifier Source: org_study_id
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