Immunogenicity and Reactogenicity of Fluarix™ (Influsplit SSW®) 2007/2008 in People 18 Years Old or Above

This study has been completed.

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00476307

Purpose

This study is designed to test the immunogenicity and reactogenicity of the Fluarix™/Influsplit SSW® containing the influenza strains recommended for the 2007-2008 season.

Condition	Intervention	Phase
Influenza	Biological: Fluarix™/Influsplit SSW® 2007/2008	Phase III

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines Fluvirin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix™ (Influsplit SSW®) 2007/2008 in People Aged 18 Years or Above

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Immune response 21 days post vaccination

Secondary Outcome Measures:

Safety: solicited local and general symptoms, unsolicited symptoms, serious adverse events

Estimated Enrollment:	120
Study Start Date:	June 2007
Study Completion 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 or female aged 18 years or above;
Non-childbearing or using adequate contraception;
Written informed consent obtained from the subject.

Exclusion Criteria:

Subjects must not:

Participate in a trial or using non-registered product;
Use immunosuppressants, blood products, or another influenza vaccine during study;
Have virologically confirmed influenza within 1 year;
Have allergic or acute disease;
Have unstabilized serious chronic disease;
Be a lactating female.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00476307

Locations

Germany, Sachsen
GSK Investigational Site
Freital, Sachsen, Germany, 01705
GSK Investigational Site
Dresden, Sachsen, Germany, 01307
GSK Investigational Site
Dresden, Sachsen, Germany, 01099

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	110221
Study First Received:	May 21, 2007
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00476307
Health Authority:	Germany: Paul-Ehrlich-Institut

Keywords provided by GlaxoSmithKline:

Flu vaccine

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

RNA Virus Infections

ClinicalTrials.gov processed this record on January 16, 2009