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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:
ClinicalTrials.gov Identifier:
NCT00377611
First Posted: September 18, 2006
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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
Intervention Model: Single Group Assignment
Masking: None (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

Enrollment: 3054
Study Start Date: October 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00377611


  Show 37 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 107564
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 107564
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 107564
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 107564
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 107564
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 107564
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00377611     History of Changes
Other Study ID Numbers: 107564
First Submitted: September 15, 2006
First Posted: September 18, 2006
Last Update Posted: October 12, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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