Study on the Incidence of Influenza and Its Complications, in Subjects Aged 50 Years and Over Vaccinated With Fluarix™ - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00377611

Purpose

An observational study to investigate the incidence of influenza and influenza-related complications, in adults between 50-64 years and elderly adults 65 years and over vaccinated with Fluarix™

Condition	Intervention	Phase
Influenza	Biological: Fluarix™	Phase IV

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, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Observational Study to Investigate the Incidence of Influenza and Influenza-Related Complications, in Adults Between 50-64 Years and Elderly Adults 65 Years and Over Vaccinated With Fluarix™

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Incidence of influenza-like-illness
Incidence of laboratory-confirmed influenza infection
Incidence of hospitalizations, emergency room visits, or unscheduled medical office visits due to influenza-like-illness
Incidence of hospitalizations, emergency room visits or unscheduled medical office visits, due to laboratory confirmed influenza
Incidence of hospitalization or emergency room visit for any cause
Incidence of influenza-related complications
Incidence of hospitalizations, emergency room visits, or unscheduled medical office visits due to influenza-related complications
Number of deaths due to laboratory confirmed influenza infection
Number of deaths
Incidence of laboratory-confirmed Respiratory Syncytial Virus infection
Patient Reported Outcome measures related to quality of life and health economics
Serious adverse events
Immune response at days 0 and 21

Estimated Enrollment:	3000
Study Start Date:	October 2006
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

A male or female age 50 years or older at the time of the first vaccination.
non-childbearing female
Availability to follow up by phone
Subjects with residence status allowing free mixing with general community

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
Any contra-indication to intramuscular administration of Fluarix™
For subjects enrolled in the immunogenicity subset only: administration of immune-modifying drugs within 7 days prior to the vaccination

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00377611

Show 37 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	107564
Study First Received:	September 15, 2006
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00377611
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

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:

RNA Virus Infections

ClinicalTrials.gov processed this record on January 15, 2009