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

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00306982

Enrollment

1524

Registered

2006-03-27

Start date

2006-03-31

Completion date

2006-12-31

Last updated

2016-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

Prophylaxis Influenza vaccine

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™.

Interventions

BIOLOGICALFluarix

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Yes

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.

Countries

Australia, Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026