Expired Study
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Memphis, Tennessee 38105


Purpose:

This is an open label-study of Fluzone HD, a high-dose form of trivalent, inactivated influenza vaccine (TIV), vs. Fluzone, a standard-dose form of TIV. Subjects with cancer or HIV will be vaccinated twice with one of the two vaccines and evaluated for development of immune responses.


Study summary:

The primary objectives of this study are to compare the immune response of Fluzone HD, a high-dose, trivalent influenza vaccine (TIV), to Fluzone, a standard-dose TIV, in children with cancer and in children with HIV. 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.


Criteria:

Inclusion Criteria: - Age 3 years (on or past their 3rd birthday) through 21 years of age (not yet reached their 22nd birthday) at the time of entry into the study. - 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 - Severe hypersensitivity to egg proteins or any component of Fluzone, or life-threatening reactions after any previous administration of any influenza vaccine; - 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


NCT ID:

NCT01205581


Primary Contact:

Principal Investigator
Jonathan A McCullers, MD
St. Jude Children's Research Hospital


Backup Contact:

N/A


Location Contact:

Memphis, Tennessee 38105
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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