No Conditions
Conditions
Keywords
Healthy adults aged 50 or older
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 trainings.
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 this age group will provide preliminary data for expanded future studies in the elderly.
Interventions
BEHAVIORALHealth Education
CDs, techniques, advice, and group training pertaining to a healthier lifestyle. Both groups will have this intervention, but the specific type of health education training will vary between groups.
BEHAVIORALHealth Education Training
8 weeks of group training regarding health education techniques.
Sponsors
Centers for Disease Control and Prevention
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunoglobin antibody response | pre and post following 8 weeks of health management training |
Countries
United States
Outcome results
None listed