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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Pilot Study Comparing High-Dose Influenza Vaccine to Standard-Dose Influenza Vaccine in Adult Oncology Patients Less Than 65 Years Receiving Chemotherapy

Conditions
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Cancer, Influenza Viral Infections

Intervention / Treatment
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* Biological: Standard Trivalent Influenza Vaccine
* Biological: High-Dose Influenza Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-Dose Influenza Vaccine<br> | Biological: High-Dose Influenza Vaccine<br>* 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.<br>* Other names: Fluzone High-Dose;|
| Active Comparator: Standard Trivalent Influenza Vaccine<br> | Biological: Standard Trivalent Influenza Vaccine<br>* 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.<br>* Other names: Fluzone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Geometric Mean Titer (GMT) of High-dose Influenza Vaccine vs the Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Who Are Less Than 65 Years Old. | Measure Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) immunogenicity of high-dose (HD) and standard dose (SD) vaccine before and after vaccination at day 28. | Baseline and 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Seroprotection Rate of High-dose Influenza Vaccine vs Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old. | Seroprotection rate was defined as the percentage of patients with a HAI GMT of at least 1:40 28 days after vaccination. | 28 days | 
| The Seroconversion Rate of High-dose Influenza Vaccine Versus Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old. | Seroconversion rate was defined as the percentage of patients with a greater than or equal to 4-fold increase in HAI titer 28 days after vaccination. | Baseline and 28 days | 
| Evaluate and Compare the Local Solicited Adverse Events to Both Vaccines. | Local solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine | 7 days | 
| Evaluate and Compare the Systemic Solicited Adverse Events to Both Vaccines. | Systemic solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine | 7 days | 
| Evaluate and Compare the Local and Systemic Unsolicited Adverse Events to Both Vaccines. | Unsolicited adverse events occurring in more than one patient, standard-dose (SD) vaccine and high-dose (HD) vaccine | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza vaccine, Oncology, Chemotherapy