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

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.
 
ClinicalTrials.gov Identifier: NCT00377611
Recruitment Status : Completed
First Posted : September 18, 2006
Results First Posted : October 9, 2018
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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™

Condition or disease Intervention/treatment Phase
Influenza Biological: Fluarix™ Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3054 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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™
Actual Study Start Date : October 5, 2006
Actual Primary Completion Date : June 20, 2007
Actual Study Completion Date : June 20, 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

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™



Primary Outcome Measures :
  1. Number of Subjects With at Least One Influenza-like-infection (ILI) Episode [ Time Frame: From Month 0 to Month 6 ]
    Analysis included all non-confirmed or lab confirmed ILI episodes (at least 1 episode, 1 episode, 2 episodes or more than (>) 2 episodes) reported.

  2. Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B [ Time Frame: From Month 0 to Month 6 ]
    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.

  3. Number of Subjects With Hospitalization, Emergency Room Visits, or Unscheduled Medical Office Visits Due to ILI [ Time Frame: From Month 0 to Month 6 ]
    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.

  4. Number of Subjects With Hospitalizations, Emergency Room Visits or Unscheduled Medical Office Visits, Due to Laboratory Confirmed Influenza [ Time Frame: From Month 0 to Month 6 ]
    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.

  5. Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause [ Time Frame: From Month 0 to Month 6 ]
    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).

  6. Number of Subjects With Emergency Room Visits, or Unscheduled Medical Office Visits Due to Influenza-related Complications [ Time Frame: From Month 0 to Month 6 ]
    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.

  7. Number of Subjects With Influenza-related Complications [ Time Frame: From Month 0 to Month 6 ]
    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).

  8. Number of Subjects With Fatal Outcomes Due to Laboratory Confirmed Influenza Infection [ Time Frame: From Month 0 to Month 6 ]
    Death due to lab confirmed influenza infection was recorded during the influeza period only.

  9. Number of Subjects With Fatal Outcomes [ Time Frame: From Month 0 to Month 6 ]
    Number of deaths caused by laboratory non-confirmed ILI or other reasons were recorded during the influenza

  10. Number of Subjects With Laboratory-confirmed Respiratory Syncytial Virus Infection (RSV) [ Time Frame: From Month 0 to Month 6 ]
    RSV infection was determined by the RT-PCR assay.

  11. Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: From Month 0 to Month 6 ]
    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.

  12. Number of Seroconverted Subjects for Each Influenza Strain [ Time Frame: At Day 21 ]
    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.

  13. Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease [ Time Frame: At Day 21 ]
    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.

  14. Number of Seroprotected Subjects Against the 3 Influenza Strains [ Time Frame: At Day 0 (PRE) ]
    A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥1:40.

  15. Number of Seroprotected Subjects Against the 3 Influenza Strains [ Time Frame: At Day 21 ]
    A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥1:40.

  16. Number of Seropositive Subjects for Each Influenza Strain [ Time Frame: At Day 0 (PRE) ]
    A seropositive subject was defined as a vaccinated subject with antibody titer ≥1:10.

  17. Number of Seropositive Subjects for Each Influenza Strain [ Time Frame: At Day 21 ]
    A seropositive subject was defined as a vaccinated subject with an antibody titer ≥1:10.

  18. Serum HI Antibody Titers for Each Influenza Strain [ Time Frame: At Day 0 (PRE) ]
    Serum HI antibody titers were expressed as Geometric Mean Titers (GMTs).

  19. Serum HI Antibody Titers for Each Influenza Strain [ Time Frame: At Day 21 ]
    Serum HI antibody titers were expressed as Geometric Mean Titers (GMTs).



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.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
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

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


Locations
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United States, Alabama
GSK Investigational Site
Mobile, Alabama, United States, 36608
United States, Florida
GSK Investigational Site
Delray Beach, Florida, United States, 33484
GSK Investigational Site
Pembroke Pines, Florida, United States, 33024
United States, Nevada
GSK Investigational Site
Las Vegas, Nevada, United States, 89104
United States, New Jersey
GSK Investigational Site
Somers Point, New Jersey, United States, 08244
United States, New York
GSK Investigational Site
Camillus, New York, United States, 13031
United States, North Carolina
GSK Investigational Site
Raleigh, North Carolina, United States, 27612
United States, Pennsylvania
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
United States, Virginia
GSK Investigational Site
Norfolk, Virginia, United States, 23507
Germany
GSK Investigational Site
Gueglingen, Baden-Wuerttemberg, Germany, 74363
GSK Investigational Site
Rudersberg, Baden-Wuerttemberg, Germany, 73635
GSK Investigational Site
Weinheim, Baden-Wuerttemberg, Germany, 69469
GSK Investigational Site
Potsdam, Brandenburg, Germany, 14469
GSK Investigational Site
Frankfurt/Main, Hessen, Germany, 60596
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45359
GSK Investigational Site
Witten, Nordrhein-Westfalen, Germany, 58455
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
GSK Investigational Site
Rhaunen, Rheinland-Pfalz, Germany, 55624
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39112
GSK Investigational Site
Dresden, Sachsen, Germany, 01067
GSK Investigational Site
Leipzg, Sachsen, Germany, 04109
GSK Investigational Site
Leipzig, Sachsen, Germany, 04103
GSK Investigational Site
Leipzig, Sachsen, Germany, 04229
GSK Investigational Site
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, 22335
GSK Investigational Site
Hamburg, Germany, 22415
GSK Investigational Site
Hamburg, Germany, 22525
Netherlands
GSK Investigational Site
Utrecht, Netherlands, 3584 CX
Poland
GSK Investigational Site
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
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
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

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00377611    
Other Study ID Numbers: 107564
First Posted: September 18, 2006    Key Record Dates
Results First Posted: October 9, 2018
Last Update Posted: October 9, 2018
Last Verified: June 2018
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Keywords provided by GlaxoSmithKline:
Influenza vaccine
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases