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

NCT00377611 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 107564
• Study Type: interventional
• Target: 3,054
• Locations: 4 countries
• Sites: 37

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

Keywords

Influenza vaccine

Outcome Measures

Primary Outcomes (19)

• 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

Study Arms (2)

FLUARIX 50-64 YEARS GROUP

EXPERIMENTAL

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™

FLUARIX 65+ YEARS GROUP

EXPERIMENTAL

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™

Interventions

Fluarix™ BIOLOGICAL

FLUARIX 50-64 YEARS GROUP; FLUARIX 65+ YEARS GROUP

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (37)

GSK Investigational Site

Mobile, Alabama, 36608, United States

Location

GSK Investigational Site

Delray Beach, Florida, 33484, United States

Location

GSK Investigational Site

Pembroke Pines, Florida, 33024, United States

Location

GSK Investigational Site

Las Vegas, Nevada, 89104, United States

Location

GSK Investigational Site

Somers Point, New Jersey, 08244, United States

Location

GSK Investigational Site

Camillus, New York, 13031, United States

Location

GSK Investigational Site

Raleigh, North Carolina, 27612, United States

Location

GSK Investigational Site

Pittsburgh, Pennsylvania, 15241, United States

Location

GSK Investigational Site

Norfolk, Virginia, 23507, United States

Location

GSK Investigational Site

Güglingen, Baden-Wurttemberg, 74363, Germany

Location

GSK Investigational Site

Rudersberg, Baden-Wurttemberg, 73635, Germany

Location

GSK Investigational Site

Weinheim, Baden-Wurttemberg, 69469, Germany

Location

GSK Investigational Site

Potsdam, Brandenburg, 14469, Germany

Location

GSK Investigational Site

Frankfurt am Main, Hesse, 60596, Germany

Location

GSK Investigational Site

Essen, North Rhine-Westphalia, 45359, Germany

Location

GSK Investigational Site

Witten, North Rhine-Westphalia, 58455, Germany

Location

GSK Investigational Site

Mainz, Rhineland-Palatinate, 55131, Germany

Location

GSK Investigational Site

Rhaunen, Rhineland-Palatinate, 55624, Germany

Location

GSK Investigational Site

Dresden, Saxony, 01067, Germany

Location

GSK Investigational Site

Leipzg, Saxony, 04109, Germany

Location

GSK Investigational Site

Leipzig, Saxony, 04103, Germany

Location

GSK Investigational Site

Leipzig, Saxony, 04229, Germany

Location

GSK Investigational Site

Magdeburg, Saxony-Anhalt, 39112, Germany

Location

GSK Investigational Site

Berlin, 10117, Germany

Location

GSK Investigational Site

Berlin, 10717, Germany

Location

GSK Investigational Site

Berlin, 13359, Germany

Location

GSK Investigational Site

Hamburg, 22143, Germany

Location

GSK Investigational Site

Hamburg, 22335, Germany

Location

GSK Investigational Site

Hamburg, 22415, Germany

Location

GSK Investigational Site

Hamburg, 22525, Germany

Location

GSK Investigational Site

Utrecht, 3584 CX, Netherlands

Location

GSK Investigational Site

Dębica, 39-200, Poland

Location

GSK Investigational Site

Krakow, 31-305, Poland

Location

GSK Investigational Site

Mielec, 39-300, Poland

Location

GSK Investigational Site

Porąbka, Poland

Location

GSK Investigational Site

Siemianowice Śląskie, 41-103, Poland

Location

GSK Investigational Site

Wroclaw, 50-088, Poland

Location

Related 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.

MeSH Terms

Conditions

Influenza, Human

Interventions

fluarix

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Limitations and Caveats

None reported.

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2006
• First Posted: September 18, 2006
• Study Start: October 5, 2006
• Primary Completion: June 20, 2007
• Study Completion: June 20, 2007
• Last Updated: October 9, 2018
• Results First Posted: October 9, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share

Locations

DE (21); US (9); PL (6); NL (1)