A Phase III, Open-Label, Single-Dose Study to Evaluate the Safety and Immunogenicity of Fluviral® Vaccine

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Influenza

Treatments

Biological: Fluviral®

Study type

Interventional

Funder types

Industry

Identifiers

NCT00505453

110502

Details and patient eligibility

About

Vaccination is currently the most effective means of controlling influenza and preventing its complications and mortality in persons at risk.

Once a year, a meeting of WHO experts takes place, leading to a recommendation on the influenza A and B strains that should be used for the production of vaccine for the coming influenza season.

This study is designed to test the safety/reactogenicity and the immunogenicity of the Fluviral Trivalent Split Virion Influenza Vaccine containing the influenza strains recommended for the 2007-2008 season.

Enrollment

110 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male and female adults, 18 years of age and older.
Female subject of non-childbearing potential. Written informed consent obtained from subject.

Exclusion criteria

Acute disease at the time of enrollment.
Blood pressure abnormalities.
Any immunosuppressive condition, such as HIV or cancer.
Renal impairment, hepatic dysfunction, complicated insulin-dependent diabetes mellitus.
Unstable cardiopulmonary disease requiring chronic medical therapy or associated with functional impairment.
Any demyelinating disease, including Guillain-Barré syndrome.
Alcohol consumption and/or drug abuse.
Receipt of an influenza vaccine within 9 months prior to enrollment or of any vaccines within 30 days prior to enrollment.
Any known or suspected allergy to the Fluviral vaccine.