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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Rochester General Hospital
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Saad Jamshed MD, Rochester General Hospital
ClinicalTrials.gov Identifier:
NCT01666782
First received: August 14, 2012
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Cancer
Influenza Viral Infections
Biological: Standard Trivalent Influenza Vaccine
Biological: High-Dose Influenza Vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Rochester General Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Measure Geometric Mean Titer (GMT) before and after vaccination at day 28.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High-Dose Influenza Vaccine 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
Active Comparator: Standard Trivalent Influenza Vaccine 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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01666782

Contacts
Contact: Saad Jamshed, MD 585-922-4020 saad.jamshed@rochestergeneral.org

Locations
United States, New York
Rochester General Hospital Recruiting
Rochester, New York, United States, 14621
Contact: Saad Jamshed, MD    585-922-4020    saad.jamshed@rochestergeneral.org   
Principal Investigator: Saad Jamshed, MD         
Lipson Cancer Center Linden Oaks Medical Campus Recruiting
Rochester, New York, United States, 14625
Contact: Saad Jamshed, MD    585-922-4020    saad.jamshed@rochestergeneral.org   
Principal Investigator: Saad Jamshed, MD         
Sponsors and Collaborators
Saad Jamshed MD
Sanofi
Investigators
Principal Investigator: Saad Jamshed, MD Rochester General Hospital
  More Information

No publications provided

Responsible Party: Saad Jamshed MD, Principal Investigator, Rochester General Hospital
ClinicalTrials.gov Identifier: NCT01666782     History of Changes
Other Study ID Numbers: CIC 1336-B12-1
Study First Received: August 14, 2012
Last Updated: August 27, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Rochester General Hospital:
Influenza vaccine
Oncology
Chemotherapy

Additional relevant MeSH terms:
Influenza, Human
Virus Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 18, 2014