Immunogenicity of Fluzone HD,A High Dose Influenza Vaccine, In Children With Cancer or HIV
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| City: |
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Memphis |
| State: |
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Tennessee |
| Zip Code: |
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38105 |
| Conditions: |
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HIV - Cancer |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT01205581 |
| Primary Contact: |
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Principal Investigator
Jonathan A McCullers, MD
St. Jude Children's Research Hospital
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| Backup Contact: |
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N/A |
| Location Contact: |
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Memphis, Tennessee 38105
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 17, 2013 |
| Modifications to this listing: |
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