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

Phase 4

Completed

• Conditions: Influenza
• Interventions: Biological: Fluarix™

• Registration Number: NCT00377611
• Lead Sponsor: 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™

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-09-15
• Study First Submitted QC: 2006-09-15
• Study First Posted: 2006-09-18
• Study Start: 2006-10-05
• Primary Completion: 2007-06-20
• Study Completion: 2007-06-20
• Results First Submitted: 2017-01-20
• Status Verified: 2018-06
• Results First Submitted QC: 2018-06-15
• Last Update Submitted: 2018-06-15
• Results First Posted: 2018-10-09
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3054

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FLUARIX 50-64 YEARS GROUP	Fluarix™	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.
FLUARIX 65+ YEARS GROUP	Fluarix™	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.

Primary Outcome Measures

Name	Time	Method
Number of Subjects With at Least One Influenza-like-infection (ILI) Episode	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.
Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B	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.
Number of Subjects With Hospitalization, Emergency Room Visits, or Unscheduled Medical Office Visits Due to ILI	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.
Number of Subjects With Hospitalizations, Emergency Room Visits or Unscheduled Medical Office Visits, Due to Laboratory Confirmed Influenza	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.
Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause	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).
Number of Subjects With Emergency Room Visits, or Unscheduled Medical Office Visits Due to Influenza-related Complications	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.
Number of Subjects With Influenza-related Complications	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).
Number of Subjects With Fatal Outcomes Due to Laboratory Confirmed Influenza Infection	From Month 0 to Month 6	Death due to lab confirmed influenza infection was recorded during the influeza period only.
Number of Subjects With Fatal Outcomes	From Month 0 to Month 6	Number of deaths caused by laboratory non-confirmed ILI or other reasons were recorded during the influenza
Number of Subjects With Laboratory-confirmed Respiratory Syncytial Virus Infection (RSV)	From Month 0 to Month 6	RSV infection was determined by the RT-PCR assay.
Number of Subjects With Serious Adverse Events (SAEs)	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.
Number of Seroconverted Subjects for Each Influenza Strain	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.
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease	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.
Number of Seroprotected Subjects Against the 3 Influenza Strains	At Day 21	A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥1:40.
Number of Seropositive Subjects for Each Influenza Strain	At Day 21	A seropositive subject was defined as a vaccinated subject with an antibody titer ≥1:10.
Serum HI Antibody Titers for Each Influenza Strain	At Day 21	Serum HI antibody titers were expressed as Geometric Mean Titers (GMTs).

Trial Locations

Locations (1)

GSK Investigational Site; 🇵🇱 Wroclaw, Poland