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

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™

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™

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Fluarix™

• Study Type: Interventional
• Enrollment (Actual): 3054
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • GSK Investigational Site
  • Berlin, Germany, 10717
    • GSK Investigational Site
  • Berlin, Germany, 13359
    • GSK Investigational Site
  • Hamburg, Germany, 22143
    • GSK Investigational Site
  • Hamburg, Germany, 22415
    • GSK Investigational Site
  • Hamburg, Germany, 22335
    • GSK Investigational Site
  • Hamburg, Germany, 22525
    • GSK Investigational Site
  • Baden-Wuerttemberg
    • Gueglingen, Baden-Wuerttemberg, Germany, 74363
      • GSK Investigational Site
    • Rudersberg, Baden-Wuerttemberg, Germany, 73635
      • GSK Investigational Site
    • Weinheim, Baden-Wuerttemberg, Germany, 69469
      • GSK Investigational Site
  • Brandenburg
    • Potsdam, Brandenburg, Germany, 14469
      • GSK Investigational Site
  • Hessen
    • Frankfurt/Main, Hessen, Germany, 60596
      • GSK Investigational Site
  • Nordrhein-Westfalen
    • Essen, Nordrhein-Westfalen, Germany, 45359
      • GSK Investigational Site
    • Witten, Nordrhein-Westfalen, Germany, 58455
      • GSK Investigational Site
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • GSK Investigational Site
    • Rhaunen, Rheinland-Pfalz, Germany, 55624
      • GSK Investigational Site
  • Sachsen
    • Dresden, Sachsen, Germany, 01067
      • GSK Investigational Site
    • Leipzg, Sachsen, Germany, 04109
      • GSK Investigational Site
    • Leipzig, Sachsen, Germany, 04229
      • GSK Investigational Site
    • Leipzig, Sachsen, Germany, 04103
      • GSK Investigational Site
  • Sachsen-Anhalt
    • Magdeburg, Sachsen-Anhalt, Germany, 39112
      • GSK Investigational Site
• Netherlands
  • Utrecht, Netherlands, 3584 CX
    • GSK Investigational Site
• Poland
  • Debica, Poland, 39-200
    • GSK Investigational Site
  • Krakow, Poland, 31-305
    • GSK Investigational Site
  • Mielec, Poland, 39-300
    • GSK Investigational Site
  • Porabka, Poland
    • GSK Investigational Site
  • Siemianowice Slaskie, Poland, 41-103
    • GSK Investigational Site
  • Wroclaw, Poland, 50-088
    • GSK Investigational Site
• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • GSK Investigational Site
  • Florida
    • Delray Beach, Florida, United States, 33484
      • GSK Investigational Site
    • Pembroke Pines, Florida, United States, 33024
      • GSK Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89104
      • GSK Investigational Site
  • New Jersey
    • Somers Point, New Jersey, United States, 08244
      • GSK Investigational Site
  • New York
    • Camillus, New York, United States, 13031
      • GSK Investigational Site
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • GSK Investigational Site
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15241
      • GSK Investigational Site
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Biological: Fluarix™
Experimental: 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.	Biological: Fluarix™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With at Least One Influenza-like-infection (ILI) Episode	Analysis included all non-confirmed or lab confirmed ILI episodes (at least 1 episode, 1 episode, 2 episodes or more than (>) 2 episodes) reported.	From Month 0 to Month 6
Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B	Lab confirmed ILI episodes were assessed by means of viral culture (VC) infection (nasal and throat swabs) determination and/or using the Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) assay.	From Month 0 to Month 6
Number of Subjects With Hospitalization, Emergency Room Visits, or Unscheduled Medical Office Visits Due to ILI	ILI which led to subject hospitalization, emergency room visits and unplanned medical office visits were recorded by number (at least 1, 1, or above 1), as part of the ILI surveillance.	From Month 0 to Month 6
Number of Subjects With Hospitalizations, Emergency Room Visits or Unscheduled Medical Office Visits, Due to Laboratory Confirmed Influenza	Laboratory confirmed (LC) ILI which led to subject hospitalization, emergency room visits and unplanned medical office visits were recorded by number (at least 1, 1, or above 1), as part of the ILI surveillance.	From Month 0 to Month 6
Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause	As part of ILI surveillance any reasons, or other reasons than those mentioned which led to subject hospitalization, emergency room visits and unplanned medical office visits were recorded by number (at least 1, 1, or above 1).	From Month 0 to Month 6
Number of Subjects With Emergency Room Visits, or Unscheduled Medical Office Visits Due to Influenza-related Complications	ILI complications which led to subject hospitalization, emergency room visits and unplanned medical office visits were recorded by number (at least 1, 1, or above 1) as part of the ILI surveillance, which included: pneumonia, ischemic heart disease, congestive failure, acute cerebrovascular disease chronic obstructive pulmonary disease (COPD) exacerbation.	From Month 0 to Month 6
Number of Subjects With Influenza-related Complications	ILI complications refer to episodes of pneumonia, ischemic heart disease [HD] (unstable angina or myocardial infarction), congestive heart failure [HF], acute cerebrovascular disease [ACD] (stroke or transient ischemic attack [IA]), COPD exacerbation and all illnesses (pooled episode of each illness). ILI complications were recorded by number of episodes (at least 1 episode, 1 episode and above 1 episode).	From Month 0 to Month 6
Number of Subjects With Fatal Outcomes Due to Laboratory Confirmed Influenza Infection	Death due to lab confirmed influenza infection was recorded during the influeza period only.	From Month 0 to Month 6
Number of Subjects With Fatal Outcomes	Number of deaths caused by laboratory non-confirmed ILI or other reasons were recorded during the influenza	From Month 0 to Month 6
Number of Subjects With Laboratory-confirmed Respiratory Syncytial Virus Infection (RSV)	RSV infection was determined by the RT-PCR assay.	From Month 0 to Month 6
Number of Subjects With Serious Adverse Events (SAEs)	SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.	From Month 0 to Month 6
Number of Seroconverted Subjects for Each Influenza Strain	A seroconverted subject was defined as a subject having either a pre-vaccination hemagglutinin inhibition (HI) titer lower than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥1:10 and a minimum four-fold increase in the post-vaccination titer. Assessed influenza strains were A/New Caledonia, A/Wisconsin and B/Malaysia.	At Day 21
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease	The seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titer (GMT) post vaccination on Day 21 compared to Day 0. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.	At Day 21
Number of Seroprotected Subjects Against the 3 Influenza Strains	A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥1:40.	At Day 0 (PRE)
Number of Seroprotected Subjects Against the 3 Influenza Strains	A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥1:40.	At Day 21
Number of Seropositive Subjects for Each Influenza Strain	A seropositive subject was defined as a vaccinated subject with antibody titer ≥1:10.	At Day 0 (PRE)
Number of Seropositive Subjects for Each Influenza Strain	A seropositive subject was defined as a vaccinated subject with an antibody titer ≥1:10.	At Day 21
Serum HI Antibody Titers for Each Influenza Strain	Serum HI antibody titers were expressed as Geometric Mean Titers (GMTs).	At Day 0 (PRE)
Serum HI Antibody Titers for Each Influenza Strain	Serum HI antibody titers were expressed as Geometric Mean Titers (GMTs).	At Day 21

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2006
• Primary Completion (Actual): June 20, 2007
• Study Completion (Actual): June 20, 2007

Study Registration Dates

• First Submitted: September 15, 2006
• First Submitted That Met QC Criteria: September 15, 2006
• First Posted (Estimate): September 18, 2006

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: June 15, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Influenza vaccine
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: 107564

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Study Data/Documents

1. Dataset Specification
   Information identifier: 107564
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Statistical Analysis Plan
   Information identifier: 107564
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Individual Participant Data Set
   Information identifier: 107564
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Clinical Study Report
   Information identifier: 107564
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Informed Consent Form
   Information identifier: 107564
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Study Protocol
   Information identifier: 107564
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes