Flu Vaccine Study in Neuromuscular Patients 2011
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Orthopedic, Orthopedic |
| Therapuetic Areas: | Neurology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 3 - 35 |
| Updated: | 4/2/2016 |
| Start Date: | August 2011 |
| End Date: | March 2012 |
| Contact: | Shengyong Hu, MS |
| Email: | shengyong.hu@cchmc.org |
| Phone: | 513-636-3202 |
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 (HAI) antibody titers obtained pre- and
post-vaccination.
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 (HAI) antibody titers obtained pre- and
post-vaccination.
Inclusion Criteria:
- Non-ambulatory;
- Quadriceps muscle strength of MRC (Medical Research Council Scale) grade 3 or below
- Any subject who is between 3 to 8 years of age must have received at least two doses
of influenza vaccine last season or at least one dose tow or more years ago.
Exclusion Criteria:
- Subject must not have a history of severe reactions following previous immunization
with influenza vaccine.
- Subject must not have previously received a 2011-2012 influenza vaccine.
- Subject must not have a history of Guillain-Barre syndrome.
- Subject must not have received a live viral vaccine (i.e., MMR, varicella) within 28
days prior to receipt of the study vaccine.
- Subject must not have any condition that the investigator believes would render
vaccination unsafe or interfere with successful completion of the study.
We found this trial at
1
site
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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