Study Comparing High-Dose Flu Vaccine to Standard Vaccine in Cancer Patients Less Than 65 Receiving Chemotherapy (IMMUNE)

• The seroprotection rate of high-dose influenza vaccine vs standard trivalent influenza vaccine in adult subjects on chemotherapy less than 65 years old. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
• The seroconversion rate of high-dose influenza vaccine versus standard trivalent influenza vaccine in adult subjects on chemotherapy less than 65 years old. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
• Evaluate and compare the local and systemic adverse events to both vaccines. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

• Determine seroprotection rate to high-dose influenza vaccine vs standard trivalent influenza vaccine in adult subjects on chemotherapy less than 65 years old. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
• Determine the seroconversion rate to high-dose influenza vaccine versus standard trivalent influenza vaccine in adult subjects on chemotherapy less than 65 years old. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
• Evaluate and compare the local and systemic adverse events to both vaccines. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

The safety and immunogenicity of high dose influenza vaccine has not been studied in young patients receiving chemotherapy. This study will evaluate and compare the immunogenicity and safety of high dose influenza to standard dose influenza vaccine in adult oncology patients who are younger than 65 years old receiving chemotherapy.

• Cancer
• Influenza Viral Infections

• Biological: Standard Trivalent Influenza Vaccine
  Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
  Other Name: Fluzone
• Biological: High-Dose Influenza Vaccine
  Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
  Other Name: Fluzone High-Dose

• Experimental: High-Dose Influenza Vaccine
  Intervention: Biological: High-Dose Influenza Vaccine
• Active Comparator: Standard Trivalent Influenza Vaccine
  Intervention: Biological: Standard Trivalent Influenza Vaccine

Inclusion Criteria:

1. 18 years old to less than 65 years old
2. Subjects with malignancy must be receiving chemotherapy
3. Medically stable
4. Able to understand and willingness to sign a written informed consent
5. Able to comply with study procedures
6. Life expectancy of more than 3 months

7. Adequate organ function:

   • ANC >1000/mm3
   • Platelet >100,000/uL
   • Creatinine <2 mg/dL
   • AST and ALT <3 times the ULN

Exclusion Criteria:

1. Allergy to eggs
2. Prior allergy to Influenza Vaccine
3. History of Guillain-Barre Syndrome
4. Current febrile illness
5. Other immunosuppressive disease (recipients of solid organ transplant, uncontrolled HIV)
6. Autologous or Allogenic Stem Cell Transplant with in a year
7. Current immunotherapy or immunochemotherapy in the last 6 months (rituximab or ofatumumab)