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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00505453

Purpose

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.

Condition	Intervention	Phase
Influenza	Biological: Fluviral®	Phase III

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III, Open-Label, Single-Dose Study to Evaluate the Safety and Immunogenicity of Fluviral® Trivalent Split Virion Influenza Vaccine (2007 - 2008 Season) in Adults Ranging in Age From 18 to 60 Years and 61 Years and Over

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Fluvirin Influenza Vaccines

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

To evaluate the immunogenicity of Fluviral influenza vaccine in adults 18 years or older [ Time Frame: 21 days after vaccination ]

Secondary Outcome Measures:

Evaluate safety & reactogenicity: Solicited AEs [ Time Frame: 4 days ]
Evaluate safety & reactogenicity: Unsolicited AEs [ Time Frame: 21 days ]
Evaluate safety & reactogenicity: SAEs [ Time Frame: entire study ]

Estimated Enrollment:	110
Study Start Date:	July 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00505453

Locations

Canada
GSK Investigational Site
Quebec, Canada, G1W 4R4
Canada, Quebec
GSK Investigational Site
Sherbrooke, Quebec, Canada, J1H 1Z1

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	110502
Study First Received:	July 20, 2007
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00505453 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by GlaxoSmithKline:

Influenza

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

Additional relevant MeSH terms:

Virus Diseases
RNA Virus Infections
Respiratory Tract Diseases

Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

ClinicalTrials.gov processed this record on September 11, 2009