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

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