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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014