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

May 23, 2016 updated by: Saad Jamshed MD

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14621
        • Rochester General Hospital
      • Rochester, New York, United States, 14625
        • Lipson Cancer Center Linden Oaks Medical Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Fluzone

What is the study measuring?

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.
Time Frame: Baseline and 28 days
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.
Time Frame: 28 days
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.
Time Frame: Baseline and 28 days
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.
Time Frame: 7 days
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.
Time Frame: 7 days
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.
Time Frame: 28 days
Unsolicited adverse events occurring in more than one patient, standard-dose (SD) vaccine and high-dose (HD) vaccine
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saad Jamshed MD

Collaborators

Sanofi

Investigators

  • Principal Investigator: Saad Jamshed, MD, Rochester General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

August 14, 2012

First Submitted That Met QC Criteria

August 14, 2012

First Posted (Estimate)

August 16, 2012

Study Record Updates

Last Update Posted (Estimate)

June 24, 2016

Last Update Submitted That Met QC Criteria

May 23, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIC 1336-B12-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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