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Trial record 6 of 8 for:    "Congenital Muscular dystrophy"

Flu Vaccine Study in Neuromuscular Patients 2011

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ClinicalTrials.gov Identifier: NCT01422200
Recruitment Status : Unknown
Verified August 2011 by Children's Hospital Medical Center, Cincinnati.
Recruitment status was:  Recruiting
First Posted : August 23, 2011
Last Update Posted : August 23, 2011
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

August 22, 2011
August 23, 2011
August 23, 2011
August 2011
December 2011   (Final data collection date for primary outcome measure)
  • Immunogenicity [ Time Frame: 21-28 days after vaccination ]
    Serum HAI antibody titers for each strain immediately prior to study vaccine receipt and 21-28 days after study vaccine receipt
  • safety [ Time Frame: 4 days following receipt of study vaccine ]
    For the 4 days following receipt of study vaccine(days 0 to 4), the following local reactions will be assessed: pain, redness, and swelling. The following systemic reactions will also be assessed: feverishness, fatigue/malaise, myalgia/body ache, headache, nausea, weakness and chills.
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Flu Vaccine Study in Neuromuscular Patients 2011
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Duchenne Muscular Dystrophy
  • Spinal Muscular Atrophy
  • Congenital Muscular Dystrophy
  • Biological: 2011-2012 seasonal flu vaccine
    The 2011-2012 seasonal flu vaccine will be given by subcutaneous injection.
    Other Name: fluzone
  • Biological: 2011-2012 seasonal flu vaccine
    the 2011-2012 seasonal flu vaccine will be given by intramuscular injection
    Other Name: fluzone
  • Experimental: Subcutaneous
    Intervention: Biological: 2011-2012 seasonal flu vaccine
  • Active Comparator: Intromuscular
    Intervention: Biological: 2011-2012 seasonal flu vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
30
Same as current
March 2012
December 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
3 Years to 35 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01422200
2010-2319
No
Not Provided
Not Provided
Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
Not Provided
Principal Investigator: Brenda Wong, MD Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP