Status:
COMPLETED
Flu Vaccine Study in Neuromuscular Patients 2011
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Duchenne Muscular Dystrophy
Spinal Muscular Atrophy
Eligibility:
All Genders
3-35 years
Phase:
PHASE4
Brief 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 ne...
Detailed Description
Individuals with neuromuscular diseases are more prone to influenza-related morbidity. Vaccination is the most effective measure to reduce the influenza disease burden. In the United States, the recom...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01422200
Start Date
August 1 2011
End Date
May 1 2012
Last Update
October 19 2020
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