- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00306982
Incidence of Influenza, Downstream Complications of Influenza & Hospitalizations in Elderly Vaccinated With Fluarix™
October 11, 2016 updated by: GlaxoSmithKline
An Observational Study to Investigate the Incidence of Influenza, Downstream Complications of Influenza and Hospitalizations, in Elderly Subjects Vaccinated With GSK Biologicals' Influenza Vaccine (Fluarix™) Administered Intramuscularly.
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™.
Study Overview
Detailed Description
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™.
Study Type
Observational
Enrollment (Actual)
1524
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Australian Capital Territory
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Garran, Australian Capital Territory, Australia, 2606
- GSK Investigational Site
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New South Wales
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Umina, New South Wales, Australia, 2257
- GSK Investigational Site
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Queensland
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Auchenflower, Queensland, Australia, 4066
- GSK Investigational Site
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Kippa Ring, Queensland, Australia, 4021
- GSK Investigational Site
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South Brisbane, Queensland, Australia, 4101
- GSK Investigational Site
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Tasmania
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Hobart, Tasmania, Australia
- GSK Investigational Site
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Victoria
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Clayton, Victoria, Australia, 3168
- GSK Investigational Site
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Heidelberg Heights, Victoria, Australia, 3084
- GSK Investigational Site
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Parkville, Victoria, Australia, 3050
- GSK Investigational Site
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- GSK Investigational Site
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São Paulo, Brazil, 04020050
- GSK Investigational Site
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Paraná
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Curitiba/Paraná, Paraná, Brazil, 80810-050
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Time Perspectives: Prospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Primary Completion (Actual)
December 1, 2006
Study Completion (Actual)
December 1, 2006
Study Registration Dates
First Submitted
February 27, 2006
First Submitted That Met QC Criteria
March 24, 2006
First Posted (Estimate)
March 27, 2006
Study Record Updates
Last Update Posted (Estimate)
October 12, 2016
Last Update Submitted That Met QC Criteria
October 11, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 106622
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study Data/Documents
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Dataset Specification
Information identifier: 106622Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Clinical Study Report
Information identifier: 106622Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Study Protocol
Information identifier: 106622Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Statistical Analysis Plan
Information identifier: 106622Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Informed Consent Form
Information identifier: 106622Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Individual Participant Data Set
Information identifier: 106622Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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