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

Phase 2

Completed

• Conditions: Cancer; Influenza Viral Infections
• Interventions: Biological: Standard Trivalent Influenza Vaccine; Biological: High-Dose Influenza Vaccine

• Registration Number: NCT01666782
• Lead Sponsor: Saad Jamshed MD

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-14
• Study First Submitted QC: 2012-08-14
• Study First Posted: 2012-08-16
• Primary Completion: 2015-06
• Study Completion: 2015-12
• Results First Submitted: 2016-01-29
• Results First Submitted QC: 2016-04-15
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-23
• Results First Posted: 2016-05-24
• Last Update Posted: 2016-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Trivalent Influenza Vaccine	Standard Trivalent Influenza Vaccine	-
High-Dose Influenza Vaccine	High-Dose Influenza Vaccine	-

Primary Outcome Measures

Name	Time	Method
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.	Baseline and 28 days	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.

Secondary Outcome Measures

Name	Time	Method
Evaluate and Compare the Systemic Solicited Adverse Events to Both Vaccines.	7 days	Systemic solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine
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	Seroprotection rate was defined as the percentage of patients with a HAI GMT of at least 1:40 28 days after vaccination.
Evaluate and Compare the Local Solicited Adverse Events to Both Vaccines.	7 days	Local solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine
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	Seroconversion rate was defined as the percentage of patients with a greater than or equal to 4-fold increase in HAI titer 28 days after vaccination.
Evaluate and Compare the Local and Systemic Unsolicited Adverse Events to Both Vaccines.	28 days	Unsolicited adverse events occurring in more than one patient, standard-dose (SD) vaccine and high-dose (HD) vaccine

Trial Locations

Locations (2)

Lipson Cancer Center Linden Oaks Medical Campus; 🇺🇸 Rochester, New York, United States

Rochester General Hospital; 🇺🇸 Rochester, New York, United States