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

Flu Vaccine Study in Neuromuscular Patients 2011

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by Children's Hospital Medical Center, Cincinnati.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati Identifier:
First received: August 22, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
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.

Condition Intervention
Duchenne Muscular Dystrophy
Spinal Muscular Atrophy
Congenital Muscular Dystrophy
Biological: 2011-2012 seasonal flu vaccine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Comparison of the Immunogenicity of Intramuscular Versus Subcutaneous Administration of Trivalent Inactivated Influenza Vaccine in Individuals With Neuromuscular Diseases

Resource links provided by NLM:

Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 30
Study Start Date: August 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Subcutaneous Biological: 2011-2012 seasonal flu vaccine
The 2011-2012 seasonal flu vaccine will be given by subcutaneous injection.
Other Name: fluzone
Active Comparator: Intromuscular Biological: 2011-2012 seasonal flu vaccine
the 2011-2012 seasonal flu vaccine will be given by intramuscular injection
Other Name: fluzone


Ages Eligible for Study:   3 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01422200

United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Principal Investigator: Brenda Wong, MD Children's Hospital Medical Center, Cincinnati
  More Information

Responsible Party: Children's Hospital Medical Center, Cincinnati Identifier: NCT01422200     History of Changes
Other Study ID Numbers: 2010-2319 
Study First Received: August 22, 2011
Last Updated: August 22, 2011

Keywords provided by Children's Hospital Medical Center, Cincinnati:
flu vaccine

Additional relevant MeSH terms:
Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Atrophy
Muscular Atrophy, Spinal
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Pathological Conditions, Anatomical
Genetic Diseases, X-Linked
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
Spinal Cord Diseases
Central Nervous System Diseases
Motor Neuron Disease
Neurodegenerative Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on February 20, 2017