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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Influenza

Treatments: Biological: Fluarix

Study type: Observational

Funder types: Industry

Identifiers

NCT00306982

106622

Details and patient eligibility

About

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™.

Full 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™.

Enrollment: 1,524 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.