Study Comparing High-Dose Flu Vaccine to Standard Vaccine in Cancer Patients Less Than 65 Receiving Chemotherapy
Information source: Rochester General Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cancer; Influenza Viral Infections
Intervention: Standard Trivalent Influenza Vaccine (Biological); High-Dose Influenza Vaccine (Biological)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Saad Jamshed MD Official(s) and/or principal investigator(s):
Saad Jamshed, MD, Principal Investigator, Affiliation: Rochester General Hospital
Summary
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.
Clinical Details
Official 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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
Primary outcome: 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.
Secondary outcome: The seroprotection rate of high-dose influenza vaccine vs standard trivalent influenza vaccine in adult subjects on chemotherapy less than 65 years old.The seroconversion rate of high-dose influenza vaccine versus standard trivalent influenza vaccine in adult subjects on chemotherapy less than 65 years old. Evaluate and compare the local and systemic adverse events to both vaccines.
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Lipson Cancer Center Linden Oaks Medical Campus, Rochester, New York 14625, United States
Rochester General Hospital, Rochester, New York 14621, United States
Additional Information
Starting date: August 2012
Last updated: May 6, 2015
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