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Flu Vaccine Study in Neuromuscular Patients 2011

This study is currently recruiting participants.
Verified August 2011 by Children's Hospital Medical Center, Cincinnati
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01422200
First received: August 22, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Immunogenicity [ Time Frame: 21-28 days after vaccination ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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

  Eligibility

Ages Eligible for Study:   3 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01422200

Contacts
Contact: Shengyong Hu, MS 513-636-3202 shengyong.hu@cchmc.org

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Shengyong Hu, MS     513-636-3202     shengyong.hu@cchmc.org    
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Brenda Wong, MD Children's Hospital Medical Center, Cincinnati
  More Information

No publications provided

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01422200     History of Changes
Other Study ID Numbers: 2010-2319
Study First Received: August 22, 2011
Last Updated: August 22, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Muscular Dystrophy, Duchenne
Muscular Atrophy
Muscular Atrophy, Spinal
Muscular Dystrophies
Neuromuscular Diseases
Atrophy
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
 Genetic Diseases, X-Linked
Genetic Diseases, Inborn
Neuromuscular Manifestations
Neurologic Manifestations
Pathological Conditions, Anatomical
Signs and Symptoms
Spinal Cord Diseases
Central Nervous System Diseases
Motor Neuron Disease
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 19, 2013