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

NCT00306982 | Completed

• 1 other identifier: 106622
• Study Type: observational
• Target: 1,524
• Locations: 2 countries
• Sites: 12

Brief Summary

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™.

Conditions

Influenza

Keywords

Prophylaxis Influenza vaccine

Interventions

Fluarix BIOLOGICAL

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (12)

GSK Investigational Site

Garran, Australian Capital Territory, 2606, Australia

Location

GSK Investigational Site

Umina, New South Wales, 2257, Australia

Location

GSK Investigational Site

Auchenflower, Queensland, 4066, Australia

Location

GSK Investigational Site

Kippa-Ring, Queensland, 4021, Australia

Location

GSK Investigational Site

South Brisbane, Queensland, 4101, Australia

Location

GSK Investigational Site

Hobart, Tasmania, Australia

Location

GSK Investigational Site

Clayton, Victoria, 3168, Australia

Location

GSK Investigational Site

Heidelberg Heights, Victoria, 3084, Australia

Location

GSK Investigational Site

Parkville, Victoria, 3050, Australia

Location

GSK Investigational Site

Nedlands, Western Australia, 6009, Australia

Location

GSK Investigational Site

Curitiba/Paraná, Paraná, 80810-050, Brazil

Location

GSK Investigational Site

São Paulo, São Paulo, 04020050, Brazil

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Influenza, Human

Interventions

fluarix

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2006
• First Posted: March 27, 2006
• Study Start: March 1, 2006
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: October 12, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

AU (10); BR (2)