Cancer Clinical Trial
Official title:
Immunogenicity of Fluzone HD,A High Dose Influenza Vaccine, In Children With Cancer or HIV
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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