Overview

This trial is active, not recruiting.

Conditions cancer, influenza viral infections
Treatments standard trivalent influenza vaccine, high-dose influenza vaccine
Phase phase 2
Sponsor Saad Jamshed MD
Collaborator Sanofi
Start date August 2012
End date September 2015
Trial size 120 participants
Trial identifier NCT01666782, CIC 1336-B12-1

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver)
Primary purpose prevention
Arm
(Experimental)
high-dose influenza vaccine Fluzone High-Dose
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.
(Active Comparator)
standard trivalent influenza vaccine Fluzone
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.

Primary Outcomes

Measure
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.
time frame: 28 days

Secondary Outcomes

Measure
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
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
Evaluate and compare the local and systemic adverse events to both vaccines.
time frame: 28 days

Eligibility Criteria

Male or female participants from 18 years up to 64 years old.

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)

Additional Information

Official title A Randomized Pilot Study Comparing High-Dose Influenza Vaccine to Standard-Dose Influenza Vaccine in Adult Oncology Patients Less Than 65 Years Receiving Chemotherapy
Principal investigator Saad Jamshed, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Rochester General Hospital.