Phase 4
N=22
Flu Vaccine Study in Neuromuscular Patients 2011
Duchenne Muscular Dystrophy · Spinal Muscular Atrophy · Congenital Muscular Dystrophy
Bottom Line
View on ClinicalTrials.gov: NCT01422200 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Geometric Mean Titer Ratio for Each Vaccine Strain — 3.76; 3.53; 2; 1.46 geometric mean titer ratio — p=<.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- 2011-2012 seasonal flu vaccine Subcutaneous (Biological); 2011-2012 seasonal flu vaccine Intramuscular (Biological)
- Age
- Pediatric, Adult · 3+ yrs
- Sex
- All
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titer Ratio for Each Vaccine Strain |
3.76; 3.53; 2; 1.46; 1.76; 2 | <.05 sig |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01422200). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.