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Comparison of the Immunogenicity of Intramuscular Versus Subcutaneous Administration of Trivalent Inactivated Influenza Vaccine in Individuals With Neuromuscular Diseases
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.
Details
| Lead sponsor | Children's Hospital Medical Center, Cincinnati |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 22 |
| Start date | 2011-08 |
| Completion | 2012-05 |
Conditions
- Duchenne Muscular Dystrophy
- Spinal Muscular Atrophy
- Congenital Muscular Dystrophy
Interventions
- 2011-2012 seasonal flu vaccine Subcutaneous
- 2011-2012 seasonal flu vaccine Intramuscular
Primary outcomes
- Geometric Mean Titer Ratio for Each Vaccine Strain — immediately before vaccination and 21-28 days after vaccination
Serum HI antibody titers for each vaccine strain immediately prior to study vaccine receipt and 21-28 days after study vaccine receipt