Health Management Training to Enhance Influenza Vaccine I... | NCT01256515

Studies
Health Management Training to Enhance Influenza Vaccine Immunogenicity

NCT01256515

Sponsor

Massachusetts General Hospital

Status

Completed

Last Update Posted

May 29, 2013Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

No Conditions

Interventions

Health Education
Health Education Training

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
5R01DP000339	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Sep 2011Actual

Completion Date

Jun 2012Actual

First Submitted Date

Dec 7, 2010

First Submission Date that Met QC Criteria

Dec 7, 2010

First Posted Date

Dec 8, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2013

Last Update Posted Date

May 29, 2013Estimated

Name	Class
Centers for Disease Control and Prevention	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Health Education Training Group 1	Experimental	One form of health education training	Behavioral: Health Education Behavioral: Health Education Training
Health Education Training Group 2	Active Comparator	Another form of health education training	Behavioral: Health Education Behavioral: Health Education Training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Health Education	Behavioral	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.

Measure	Description	Time Frame
Immunoglobin antibody response		pre and post following 8 weeks of health management training

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided