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

• 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: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

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

Study Design

• 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

Arms and Interventions

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™

Outcome Measures

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).

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Study Director: GSK Clinical Trials; GlaxoSmithKline

More Information

Additional Information:

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 Data/Documents: Dataset Specification 

Identifier: 107564
For additional information about this study please refer to the GSK Clinical Study Register

Statistical Analysis Plan 

Identifier: 107564
For additional information about this study please refer to the GSK Clinical Study Register

Individual Participant Data Set 

Identifier: 107564
For additional information about this study please refer to the GSK Clinical Study Register

Clinical Study Report 

Identifier: 107564
For additional information about this study please refer to the GSK Clinical Study Register

Informed Consent Form 

Identifier: 107564
For additional information about this study please refer to the GSK Clinical Study Register

Study Protocol 

Identifier: 107564
For additional information about this study please refer to the GSK Clinical Study Register

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00377611
• Other Study ID Numbers: 107564
• First Posted: September 18, 2006
• 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.

• Studies a U.S. FDA-regulated Drug Product: Yes

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