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Flu Vaccine Study in Neuromuscular Patients 2011

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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):

Study Description
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 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 or disease Intervention/treatment
Duchenne Muscular Dystrophy Spinal Muscular Atrophy Congenital Muscular Dystrophy Biological: 2011-2012 seasonal flu vaccine

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2011
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : March 2012


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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

  2. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01422200     History of Changes
Other Study ID Numbers: 2010-2319
First Posted: August 23, 2011    Key Record Dates
Last Update Posted: August 23, 2011
Last Verified: August 2011

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

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