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

NCT ID: NCT00377611

Last Updated: 2018-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 3054 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-05
• Study Completion Date: 2007-06-20

Brief Summary

A 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™

Conditions

Influenza

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

FLUARIX 50-64 YEARS GROUP

Adult subjects aged between and including 50-64 years who received a single dose of Fluarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm, were enrolled for investigation of influenza and influenza-related complications.

Group Type: EXPERIMENTAL

Fluarix™

Intervention Type: BIOLOGICAL

FLUARIX 65+ YEARS GROUP

Elderly subjects aged 65 and over who received a single dose of Fluarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm, were enrolled for investigation of influenza and influenza-related complications.

Group Type: EXPERIMENTAL

Fluarix™

Intervention Type: BIOLOGICAL

Interventions

Fluarix™

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Mobile, Alabama, United States

GSK Investigational Site

Delray Beach, Florida, United States

GSK Investigational Site

Pembroke Pines, Florida, United States

GSK Investigational Site

Las Vegas, Nevada, United States

GSK Investigational Site

Somers Point, New Jersey, United States

GSK Investigational Site

Camillus, New York, United States

GSK Investigational Site

Raleigh, North Carolina, United States

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Norfolk, Virginia, United States

GSK Investigational Site

Güglingen, Baden-Wurttemberg, Germany

GSK Investigational Site

Rudersberg, Baden-Wurttemberg, Germany

GSK Investigational Site

Weinheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Potsdam, Brandenburg, Germany

GSK Investigational Site

Frankfurt am Main, Hesse, Germany

GSK Investigational Site

Essen, North Rhine-Westphalia, Germany

GSK Investigational Site

Witten, North Rhine-Westphalia, Germany

GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

GSK Investigational Site

Rhaunen, Rhineland-Palatinate, Germany

GSK Investigational Site

Dresden, Saxony, Germany

GSK Investigational Site

Leipzg, Saxony, Germany

GSK Investigational Site

Leipzig, Saxony, Germany

GSK Investigational Site

Leipzig, Saxony, Germany

GSK Investigational Site

Magdeburg, Saxony-Anhalt, Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Hamburg, , Germany

GSK Investigational Site

Hamburg, , Germany

GSK Investigational Site

Hamburg, , Germany

GSK Investigational Site

Hamburg, , Germany

GSK Investigational Site

Utrecht, , Netherlands

GSK Investigational Site

Dębica, , Poland

GSK Investigational Site

Krakow, , Poland

GSK Investigational Site

Mielec, , Poland

GSK Investigational Site

Porąbka, , Poland

GSK Investigational Site

Siemianowice Śląskie, , Poland

GSK Investigational Site

Wroclaw, , Poland

Countries

United States; Germany; Netherlands; Poland

Study Documents

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

107564

Identifier Type: -

Identifier Source: org_study_id