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

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.

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