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

Cancer Clinical Trial

— IMMUNE  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01666782
• Other study ID #: CIC 1336-B12-1
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 14, 2012
• Last updated: May 6, 2015
• Start date: August 2012
• Est. completion date: September 2015

Study information

• Verified date: May 2015
• Source: Rochester General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Cancer
• Influenza Viral Infections
• Influenza, Human
• Virus Diseases

Intervention

Biological:
• Standard Trivalent Influenza Vaccine
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.
• High-Dose Influenza Vaccine
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.

Locations

Country	Name	City	State
United States	Lipson Cancer Center Linden Oaks Medical Campus	Rochester	New York
United States	Rochester General Hospital	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
Saad Jamshed MD	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 Geometric Mean Titer (GMT) before and after vaccination at day 28.	28 days	No
Secondary	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	No
Secondary	The seroconversion rate of high-dose influenza vaccine versus standard trivalent influenza vaccine in adult subjects on chemotherapy less than 65 years old.		28 days	No
Secondary	Evaluate and compare the local and systemic adverse events to both vaccines.		28 days	Yes