Health Management Training to Enhance Influenza Vaccine Immunogenicity
NCT ID: NCT01256515
Last Updated: 2013-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2009-11-30
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Health Education Training Group 1
One form of health education training
Health 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.
Health Education Training
8 weeks of group training regarding health education techniques.
Health Education Training Group 2
Another form of health education training
Health 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.
Health Education Training
8 weeks of group training regarding health education techniques.
Interventions
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Health 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.
Health Education Training
8 weeks of group training regarding health education techniques.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
50 Years
ALL
Yes
Sponsors
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Centers for Disease Control and Prevention
FED
Massachusetts General Hospital
OTHER
Responsible Party
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John W. Denninger, MD, PhD
Director of Research, Benson-Henry Institute
Principal Investigators
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John Denninger, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Benson-Henry Institute, 151 Merrimac St, 4th Floor
Boston, Massachusetts, United States
Countries
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Other Identifiers
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2009P001437
Identifier Type: -
Identifier Source: org_study_id
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