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NCT Number: NCT01666782

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

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Key information

Conditions

Cancer Infections Influenza Viral Infections Influenza, Human Neoplasms Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Lipson Cancer Center Linden Oaks Medical Campus, Rochester, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years old to less than 65 years old
  • Subjects with malignancy must be receiving chemotherapy
  • Medically stable
  • Able to understand and willingness to sign a written informed consent
  • Able to comply with study procedures
  • Life expectancy of more than 3 months
  • Adequate organ function:
  • ANC >1000/mm3
  • Platelet >100,000/uL
  • Creatinine <2 mg/dL
  • AST and ALT <3 times the ULN

Exclusion criteria

  • Allergy to eggs
  • Prior allergy to Influenza Vaccine
  • History of Guillain-Barre Syndrome
  • Current febrile illness
  • Other immunosuppressive disease (recipients of solid organ transplant, uncontrolled HIV)
  • Autologous or Allogenic Stem Cell Transplant with in a year
  • Current immunotherapy or immunochemotherapy in the last 6 months (rituximab or ofatumumab)

Treatment and study plan

Standard Trivalent Influenza Vaccine

Biological

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

High-Dose Influenza Vaccine

Biological

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Saad Jamshed MD

Other

Collaborators

  • Sanofi

Registry information

Official study 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

Acronym: IMMUNE

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 16, 2012
Registry last updated
Jun 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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