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

GlaxoSmithKline3,054 enrolled

Overview

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™

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

3,054

Conditions

Influenza

Interventions

Fluarix™BIOLOGICAL

Eligibility

Sex: ALLMin age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (37)

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: From Month 0 to Month 6

Number of Subjects With Emergency Room Visits, or Unscheduled Medical Office Visits Due to Influenza-related Complications

Data from ClinicalTrials.gov

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GSK Investigational Site

Mobile, Alabama, United States

GSK Investigational Site

Delray Beach, Florida, United States

GSK Investigational Site

Pembroke Pines, Florida, United States

GSK Investigational Site

Las Vegas, Nevada, United States

GSK Investigational Site

Somers Point, New Jersey, United States

GSK Investigational Site

Camillus, New York, United States

GSK Investigational Site

Raleigh, North Carolina, United States

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Norfolk, Virginia, United States

GSK Investigational Site

Güglingen, Baden-Wurttemberg, Germany

...and 27 more locations

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.

Time frame: 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).

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: At Day 21

Serum HI Antibody Titers for Each Influenza Strain

Serum HI antibody titers were expressed as Geometric Mean Titers (GMTs).

Time frame: At Day 0 (PRE)

Serum HI Antibody Titers for Each Influenza Strain

Serum HI antibody titers were expressed as Geometric Mean Titers (GMTs).

Time frame: At Day 21