drugset / Trial / NCT00766285

High Dose Influenza in Immunosuppressed Subjects

NCT00766285

RandomizedParallel-groupTriple-blindPrevention

Summary

Influenza is a common infection of the upper airways and lungs, and is caused by viruses. Cancer patients may need a stronger influenza vaccine than the general population to protect against influenza. The experimental vaccine is designed to be 9 times stronger than the standard vaccine, which may cause a stronger immune response against influenza in patients with a weakened immune system. The goal of this study is to compare the effects of a new experimental influenza vaccine to the effects of the standard influenza vaccine. One hundred bone marrow recipients, adult volunteers from the MD Anderson Cancer Center, 18 years of age or older, will participate in this study. They will be randomly (by chance) assigned to receive 2 doses of either the standard licensed influenza vaccine or the experimental influenza vaccine. Participants will be asked to complete 5 study visits and 3 telephone contacts. Study procedures include blood draws. The duration of participation is about 6 months.

Timeline

Start
Primary completion
2010-09
Completion
2010-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Influenza Virus Vaccine Vaccine 45 ug Intramuscular
Subject Trivalent Baculovirus-expressed Influenza HA vaccine Vaccine 405 ug Intramuscular

Indications