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

This study has been completed.

First Received: August 10, 2006 Last Updated: October 9, 2008 History of Changes

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00363870

Purpose

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

Condition	Intervention	Phase
Influenza	Biological: Fluarix vaccine	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Study to Demonstrate the Efficacy of GSK Biologicals' Influenza Vaccine (Fluarix™) Administered Intramuscularly in Adults

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Fluvirin Influenza Vaccines

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment:	7632
Study Start Date:	September 2006
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Eligibility

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363870

Locations

Czech Republic
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 03
Finland
GSK Investigational Site
Kotka, Finland, 48600
GSK Investigational Site
Jarvenpaa, Finland, 04400
GSK Investigational Site
Seinajoki, Finland, 60100
GSK Investigational Site
Espoo, Finland, 02100
GSK Investigational Site
Oulu, Finland, 90100
GSK Investigational Site
Vantaa, Finland, 01600
GSK Investigational Site
Pori, Finland, 28120
GSK Investigational Site
Lahti, Finland, 15140
GSK Investigational Site
Kuopio, Finland, 70100
GSK Investigational Site
Helsinki, Finland, 00100
GSK Investigational Site
Tampere, Finland, 33100
GSK Investigational Site
Turku, Finland, 20520
GSK Investigational Site
Vantaa, Finland, 01300

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	108134
Study First Received:	August 10, 2006
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00363870 History of Changes
Health Authority:	United States: Food and Drug Administration; Czech Republic: State Institute for Drug Control

Keywords provided by GlaxoSmithKline:

Influenza vaccine
Prophylaxis Influenza vaccine

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 02, 2009