Clinical Trial: Flu Vaccine Study in Neuromuscular Patients 2011

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Comparison of the Immunogenicity of Intramuscular Versus Subcutaneous Administration of Trivalent Inactivated Influenza Vaccine in Individuals With Neuromuscular Diseases

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.

Detailed Summary:
Sponsor: Children's Hospital Medical Center, Cincinnati

Current Primary Outcome:

  • 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Children's Hospital Medical Center, Cincinnati

Dates:
Date Received: August 22, 2011
Date Started: August 2011
Date Completion: March 2012
Last Updated: August 22, 2011
Last Verified: August 2011