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

Completed · Phase 2

Conditions studied: Cancer, Influenza Viral Infections

In brief

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.

Key facts

Study ID

NCT01666782

Run by

Saad Jamshed MD

People needed

105

Starts

2012-08-01

Expected to finish

2015-12-01

Last updated by the study team

2016-06-24

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years old to less than 65 years old
• Subjects with malignancy must be receiving chemotherapy
• Medically stable
• Able to understand and willingness to sign a written informed consent
• Able to comply with study procedures
• Life expectancy of more than 3 months
• Adequate organ function:
• ANC >1000/mm3
• Platelet >100,000/uL
• Creatinine <2 mg/dL
• AST and ALT <3 times the ULN

You may not qualify if…

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

Where it is running

• Rochester General Hospital — Rochester, New York, United States
• Lipson Cancer Center Linden Oaks Medical Campus — Rochester, New York, United States

Full record on ClinicalTrials.gov

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