Study Comparing High-Dose Flu Vaccine to Standard Vaccine in Cancer Patients Less Than 65 Receiving Chemotherapy
IMMUNE
A Randomized Pilot Study Comparing High-Dose Influenza Vaccine to Standard-Dose Influenza Vaccine in Adult Oncology Patients Less Than 65 Years Receiving Chemotherapy
1 other identifier
interventional
105
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 cancer
Started Aug 2012
Typical duration for phase_2 cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 14, 2012
CompletedFirst Posted
Study publicly available on registry
August 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedResults Posted
Study results publicly available
May 24, 2016
CompletedJune 24, 2016
May 1, 2016
2.8 years
August 14, 2012
January 29, 2016
May 23, 2016
Conditions
Keywords
Outcome Measures
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.
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 Outcomes (5)
The Seroprotection Rate of High-dose Influenza Vaccine vs Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.
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.
Baseline and 28 days
Evaluate and Compare the Local Solicited Adverse Events to Both Vaccines.
7 days
Evaluate and Compare the Systemic Solicited Adverse Events to Both Vaccines.
7 days
Evaluate and Compare the Local and Systemic Unsolicited Adverse Events to Both Vaccines.
28 days
Study Arms (2)
High-Dose Influenza Vaccine
EXPERIMENTALStandard Trivalent Influenza Vaccine
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Saad Jamshed MDlead
- Sanoficollaborator
Study Sites (2)
Rochester General Hospital
Rochester, New York, 14621, United States
Lipson Cancer Center Linden Oaks Medical Campus
Rochester, New York, 14625, United States
Related Publications (1)
Jamshed S, Walsh EE, Dimitroff LJ, Santelli JS, Falsey AR. Improved immunogenicity of high-dose influenza vaccine compared to standard-dose influenza vaccine in adult oncology patients younger than 65 years receiving chemotherapy: A pilot randomized clinical trial. Vaccine. 2016 Jan 27;34(5):630-635. doi: 10.1016/j.vaccine.2015.12.037. Epub 2015 Dec 22.
PMID: 26721330DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Saad Jamshed, MD
- Organization
- Rochester General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Saad Jamshed, MD
Rochester General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 14, 2012
First Posted
August 16, 2012
Study Start
August 1, 2012
Primary Completion
June 1, 2015
Study Completion
December 1, 2015
Last Updated
June 24, 2016
Results First Posted
May 24, 2016
Record last verified: 2016-05