NCT01666782

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Saad Jamshed MD · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer
• Influenza Viral Infections

Interventions

Type	Name	Description
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.
BIOLOGICAL	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.

Timeline

• Start date: 2012-08-01
• Primary completion: 2015-06-01
• Completion: 2015-12-01
• First posted: 2012-08-16
• Last updated: 2016-06-24
• Results posted: 2016-05-24

Locations

2 sites across 1 country: United States