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

Study Overview
=================
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™

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™

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Biological: Fluarix™


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FLUARIX 50-64 YEARS GROUP<br>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™<br> <br> |
| Experimental: FLUARIX 65+ YEARS GROUP<br>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™<br> <br> |

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Influenza vaccine