Infections

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Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Communicable Diseases

Influenza, Human

Virus Diseases

Respiratory Tract Infections

Orthomyxoviridae Infections

RNA Virus Infections

Respiratory Tract Diseases

All Drugs and Chemicals

Coagulants

Vaccines

Hemagglutinins

Immunologic Factors

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.

Standard Trivalent 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.

High-Dose Influenza Vaccine

Saad Jamshed, MD

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.

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

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

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.

Seroprotection rate was defined as the percentage of patients with a HAI GMT of at least 1:40 28 days after vaccination.

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.

Local solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine

Systemic solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine

Unsolicited adverse events occurring in more than one patient, standard-dose (SD) vaccine and high-dose (HD) vaccine

Sanofi

Saad Jamshed MD

Principal Investigator

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.

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.

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Pre Vaccination H1N1 Antigen

Pre Vaccination H3N2 Antigen

Pre Vaccination B Antigen

Post Vaccination H1N1 Antigen

Post Vaccination H3N2 Antigen

Post Vaccination B Antigen

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.

H1N1 Antigen

H3N2 Antigen

B Antigen

The Seroprotection Rate of High-dose Influenza Vaccine vs Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.

The Seroconversion Rate of High-dose Influenza Vaccine Versus Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.

Injection site pain- mild

Injection site pain-moderate

Injection site swelling-mild

Injection site swelling-moderate

Injection site redness-mild

Injection site redness-moderate

Injection site itching-mild

Injection site itching-moderate

Evaluate and Compare the Local Solicited Adverse Events to Both Vaccines.

Fever-mild

Fever-moderate

Fever-severe

Headache-mild

Headache-moderate

Headache-severe

Malaise-mild

Malaise-moderate

Malaise-severe

Myalgia-mild

Myalgia-moderate

Myalgia-severe

Evaluate and Compare the Systemic Solicited Adverse Events to Both Vaccines.

Fatigue: Grade 1 or 2

Fatigue: Grade 3

Nausea: Grade 1 or 2

Nausea: Grade 3

Vomiting: Grade 1 or 2

Vomiting: Grade 3

Evaluate and Compare the Local and Systemic Unsolicited Adverse Events to Both Vaccines.

Overall Study

Spots Global Cancer Trial Database for standard trivalent influenza vaccine