drugset / Trial / NCT01422200

Flu Vaccine Study in Neuromuscular Patients 2011

NCT01422200

Phase 4 Completed 22 enrolled Children's Hospital Medical Center, Cincinnati
RandomizedParallel-groupSingle-blindPrevention

Summary

The purpose of the study is to compare the immune response of two different injection methods (Intramuscular V.S. Subcutaneous) of the 2011-2012 seasonal Influenza (Flu) vaccine among patients with neuromuscular conditions who have significant muscle degeneration. This research study hypothesizes that the subcutaneous route of vaccine administration, as compared to the intramuscular route, may confer at least comparable, or possibly better, immunogenicity. At least 30 individuals followed by the CCHMC Neuromuscular Comprehensive Care Center will be recruited to participate in this study lasting approximately one to two months with two clinic visits and one follow-up telephone call. Immunogenicity will be assessed by comparing hemagglutination inhibition (HI) antibody titers obtained pre- and post-vaccination.

Timeline

Start
2011-08
Primary completion
2011-12
Completion
2012-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Influenza Virus Vaccine Vaccine 0.5 ml Subcutaneous