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

Saad Jamshed MD

Status and phase: Completed; Phase 2

Conditions: Cancer; Influenza Viral Infections

Treatments: Biological: High-Dose Influenza Vaccine; Biological: Standard Trivalent Influenza Vaccine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01666782

CIC 1336-B12-1

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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105 participants in 2 patient groups

High-Dose Influenza Vaccine

Experimental group

Treatment:

Biological: High-Dose Influenza Vaccine

Standard Trivalent Influenza Vaccine

Active Comparator group

Treatment:

Biological: Standard Trivalent Influenza Vaccine