Clinical trial NCT00306982: Incidence of Influenza, Downstream Complications of Influenza & Hospitalizations in Elderly Vaccinated With Fluarix™
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Keywords: Prophylaxis Influenza vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-03-27
Enrollment: 1524
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

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™.

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™.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Garran
country: Australia
facility: GSK Investigational Site
state: Australian Capital Territory
city: Umina
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Auchenflower
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Kippa Ring
country: Australia
facility: GSK Investigational Site
state: Queensland
city: South Brisbane
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Hobart
country: Australia
facility: GSK Investigational Site
state: Tasmania
city: Clayton
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Heidelberg Heights
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Parkville
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Nedlands
country: Australia
facility: GSK Investigational Site
state: Western Australia
city: Curitiba/Paraná
country: Brazil
facility: GSK Investigational Site
state: Paraná
city: São Paulo
country: Brazil
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: