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A Randomized Pilot Study Comparing High-Dose Influenza Vaccine to Standard-Dose Influenza Vaccine in Adult Oncology Patients Less Than 65 Years Receiving Chemotherapy


Phase 2
18 Years
64 Years
Open (Enrolling)
Both
Cancer, Influenza Viral Infections

Thank you

Trial Information

A Randomized Pilot Study Comparing High-Dose Influenza Vaccine to Standard-Dose Influenza Vaccine in Adult Oncology Patients Less Than 65 Years Receiving Chemotherapy


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)

Type of Study:

Interventional

Study Design:

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

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.

Outcome Description:

Measure Geometric Mean Titer (GMT) before and after vaccination at day 28.

Outcome Time Frame:

28 days

Safety Issue:

No

Principal Investigator

Saad Jamshed, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rochester General Hospital

Authority:

United States: Federal Government

Study ID:

CIC 1336-B12-1

NCT ID:

NCT01666782

Start Date:

August 2012

Completion Date:

August 2013

Related Keywords:

  • Cancer
  • Influenza Viral Infections
  • Influenza vaccine
  • Oncology
  • Chemotherapy
  • Influenza, Human
  • Virus Diseases

Name

Location

Rochester General HospitalRochester, New York  14621
Lipson Cancer Center Linden Oaks Medical CampusRochester, New York  14625