A Study to Demonstrate the Efficacy of GSK Biologicals' Influenza Vaccine in Adults

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Influenza

Treatments: Biological: Fluarix vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00363870

108134

Details and patient eligibility

About

The purpose of this study is to demonstrate the efficacy of GSK Biologicals' influenza vaccine (Fluarix™) administered intramuscularly in adults.

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• A male or female age between 18 and 64 years at the time of the first vaccination.
• non-childbearing female

Exclusion criteria

• Use of non-registered products
• Pregnancy
• Hypersensitivity to a previous dose of influenza vaccine
• Acute disease at the time of enrolment/vaccination.
• History of allergy or reactions likely to be exacerbated by any component of the vaccine
• Administration of any other influenza vaccine for the season 2006-2007
• Chronic disorders of the pulmonary or cardiovascular system, including asthma.
• Administration of immune-modifying drugs
• Administration of immunoglobulins and/or any blood products
• History of requiring regular medical follow-up or hospitalization during the preceding year because of chronic metabolic diseases (including diabetes mellitus), renal dysfunction, hemoglobinopathies, asthma or immunosuppression (including immunosuppression caused by medications or by human immunodeficiency virus)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind