NCT01256515

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 8, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

May 29, 2013

Status Verified

May 1, 2013

Enrollment Period

1.8 years

First QC Date

December 7, 2010

Last Update Submit

May 28, 2013

Conditions

No Conditions

Keywords

Healthy adults aged 50 or older

Outcome Measures

Primary Outcomes (1)

  • Immunoglobin antibody response

    pre and post following 8 weeks of health management training

Study Arms (2)

Health Education Training Group 1

EXPERIMENTAL

One form of health education training

Behavioral: Health EducationBehavioral: Health Education Training

Health Education Training Group 2

ACTIVE COMPARATOR

Another form of health education training

Behavioral: Health EducationBehavioral: Health Education Training

Interventions

Health EducationBEHAVIORAL

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 Group 1Health Education Training Group 2
Health Education TrainingBEHAVIORAL

8 weeks of group training regarding health education techniques.

Health Education Training Group 1Health Education Training Group 2

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • self report of any medical conditions for which the Center for Disease Control (CDC) states should not be vaccinated with IIV
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benson-Henry Institute, 151 Merrimac St, 4th Floor

Boston, Massachusetts, 02114, United States

Location

Study Officials

  • John Denninger, M.D., Ph.D.

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Research, Benson-Henry Institute

Study Record Dates

First Submitted

December 7, 2010

First Posted

December 8, 2010

Study Start

November 1, 2009

Primary Completion

September 1, 2011

Study Completion

June 1, 2012

Last Updated

May 29, 2013

Record last verified: 2013-05

Locations

US(1)