Incidence of Influenza, Downstream Complications of Influenza & Hospitalizations in Elderly Vaccinated With Fluarix™

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

1524 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-03-31

Study Completion Date

2006-12-31

Brief Summary

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This study will investigate the incidence of influenza, disease and various possible downstream complications and hospitalizations or emergency room visits after routine annual vaccination of the elderly population with Fluarix™.

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Detailed Description

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This study will investigate the incidence of influenza, disease and various possible downstream complications, such as pneumonia, ischemic HD (unstable angina or MI), congestive heart failure, acute cerebrovascular disease, COPD exacerbation and hospitalizations or emergency room visits, and will evaluate the feasibility of health outcome surveillance and the validity of using questionnaires instruments, after routine annual vaccination of the elderly population with Fluarix™.

Conditions

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Influenza

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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Fluarix

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

All subjects must satisfy to the following criteria at study entry:

* (1) A male or female age 65 years at the time of the first vaccination,
* (2) Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., return for follow-up visits, disease reporting by phone, and completion of Questionnaires) should be enrolled in the study
* (3) Written informed consent obtained from the subject
* (4) Availability to follow up by phone during the study period
* (5) Subjects with residence status allowing free mixing with general community.

Exclusion Criteria

The subject must not be included in the study for:

* (1) history of hypersensitivity to a previous dose of influenza vaccine
* (2) history of allergy or reactions likely to be exacerbated by any component of the vaccine including egg, chicken protein, formaldehyde, thimerosal, gentamicin sulfate or sodium deoxycholate,
* (3) use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Garran, Australian Capital Territory, Australia

Site Status

GSK Investigational Site

Umina, New South Wales, Australia

Site Status

GSK Investigational Site

Auchenflower, Queensland, Australia

Site Status

GSK Investigational Site

Kippa-Ring, Queensland, Australia

Site Status

GSK Investigational Site

South Brisbane, Queensland, Australia

Site Status

GSK Investigational Site

Hobart, Tasmania, Australia

Site Status

GSK Investigational Site

Clayton, Victoria, Australia

Site Status

GSK Investigational Site

Heidelberg Heights, Victoria, Australia

Site Status

GSK Investigational Site

Parkville, Victoria, Australia

Site Status

GSK Investigational Site

Nedlands, Western Australia, Australia

Site Status

GSK Investigational Site

Curitiba/Paraná, Paraná, Brazil

Site Status

GSK Investigational Site

São Paulo, São Paulo, Brazil

Site Status

Countries

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Australia Brazil

Study Documents

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