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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00377611
First received: September 15, 2006
Last updated: September 29, 2011
Last verified: September 2011
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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™

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

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)
Intervention Details:
    Biological: Fluarix™
    Other Name: Fluarix™
  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

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00377611     History of Changes
Other Study ID Numbers: 107564
Study First Received: September 15, 2006
Last Updated: September 29, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Influenza vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013