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

This study has been completed.
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: May 23, 2016
Last verified: May 2016

August 14, 2012
May 23, 2016
August 2012
June 2015   (final data collection date for primary outcome 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: Baseline and 28 days ] [ Designated as safety issue: No ]
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.
Determine the Geometric Mean Titer (GMT) to high-dose infuenza 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.
Complete list of historical versions of study NCT01666782 on ClinicalTrials.gov Archive Site
  • 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 ]
    Seroprotection rate was defined as the percentage of patients with a HAI GMT of at least 1:40 28 days after vaccination.
  • 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: Baseline and 28 days ] [ Designated as safety issue: No ]
    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.
  • Evaluate and Compare the Local Solicited Adverse Events to Both Vaccines. [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    Local solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine
  • Evaluate and Compare the Systemic Solicited Adverse Events to Both Vaccines. [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    Systemic solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine
  • Evaluate and Compare the Local and Systemic Unsolicited Adverse Events to Both Vaccines. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Unsolicited adverse events occurring in more than one patient, standard-dose (SD) vaccine and high-dose (HD) vaccine
  • Determine seroprotection rate to 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 ]
  • Determine the seroconversion rate to 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 ]
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
  • Cancer
  • Influenza Viral Infections
  • 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
  • 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
  • Experimental: High-Dose Influenza Vaccine
    Intervention: Biological: High-Dose Influenza Vaccine
  • Active Comparator: Standard Trivalent Influenza Vaccine
    Intervention: Biological: Standard Trivalent Influenza Vaccine
Jamshed S, Walsh EE, Dimitroff LJ, Santelli JS, Falsey AR. Improved immunogenicity of high-dose influenza vaccine compared to standard-dose influenza vaccine in adult oncology patients younger than 65 years receiving chemotherapy: A pilot randomized clinical trial. Vaccine. 2016 Jan 27;34(5):630-5. doi: 10.1016/j.vaccine.2015.12.037. Epub 2015 Dec 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
December 2015
June 2015   (final data collection date for primary outcome measure)

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)
Both
18 Years to 64 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01666782
CIC 1336-B12-1
No
Not Provided
Not Provided
Saad Jamshed MD, Rochester General Hospital
Saad Jamshed MD
Sanofi
Principal Investigator: Saad Jamshed, MD Rochester General Hospital
Rochester General Hospital
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP