Status:
COMPLETED
Health Management Training to Enhance Influenza Vaccine Immunogenicity
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Centers for Disease Control and Prevention
Conditions:
No Conditions
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
The goal of this study is to assess the immunogenicity of inactivated influenza vaccination (IIV) in healthy elderly volunteers aged 50 years and older receiving one of two different health management...
Detailed Description
We will obtain preliminary data on the time it takes to achieve a protective immune response, durability of response and occurrence of influenza in the following influenza season. Promising results in...
Eligibility Criteria
Inclusion
- General Inclusion criteria are the following:
- age 50 years or older
- Infectious Disease tests - negative HIV test; hepatitis B surface antigen; anti-hepatitis C virus (HCV)
- Routine Laboratory tests
- able and willing to complete the informed consent process
- able and willing to participate for the planned duration of the study, including availability for follow-up telephone contact
- General Exclusion criteria
- self report of any medical conditions for which the Center for Disease Control (CDC) states should not be vaccinated with IIV
- self-reported vaccination with the seasonal influenza vaccine for the current 2010-2011 influenza season (vaccination with the H1N1 influenza vaccine before, during, or after the study will not be exclusionary)
- history of hypersensitivity to any influenza vaccine components including thimerosal or egg
- history of Guillain-Barre syndrome
- self-reported treatment with immunomodulator/immunosuppressive drugs (interleukins (IL), corticosteroids (oral or inhaled)), G(M)- cerebrospinal fluid (CSF)) in 4 weeks before enrollment or self reported history of IL-2 administration within 5 years
- self-reported use of theophylline preparations or warfarin because of the theoretical possibilities of enhanced drug effects and toxicities following influenza vaccination
- any clinically significant abnormalities found during a routine physical examination
- self-reported history of any autoimmune disease
- acute febrile illness on the day of intended immunization - immunization deferred until illness resolved
- self report of current alcohol, substance abuse, or systemic/psychiatric illness that potentially could interfere with compliance and ability to make study visits (such as severe attention deficit hyperactivity disorder (ADHD) and current major depressive episode)
Exclusion
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01256515
Start Date
November 1 2009
End Date
June 1 2012
Last Update
May 29 2013
Active Locations (1)
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1
Benson-Henry Institute, 151 Merrimac St, 4th Floor
Boston, Massachusetts, United States, 02114