Clinical trial NCT00377611: Study on the Incidence of Influenza and Its Complications, in Subjects Aged 50 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™
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Keywords: Influenza vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-09-18
Enrollment: 3054
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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™


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

Primary outcomes:
measure: Number of Subjects With at Least One Influenza-like-infection (ILI) Episode
timeFrame: From Month 0 to Month 6
measure: Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B
timeFrame: From Month 0 to Month 6
measure: Number of Subjects With Hospitalization, Emergency Room Visits, or Unscheduled Medical Office Visits Due to ILI
timeFrame: From Month 0 to Month 6
measure: Number of Subjects With Hospitalizations, Emergency Room Visits or Unscheduled Medical Office Visits, Due to Laboratory Confirmed Influenza
timeFrame: From Month 0 to Month 6
measure: Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause
timeFrame: From Month 0 to Month 6
measure: Number of Subjects With Emergency Room Visits, or Unscheduled Medical Office Visits Due to Influenza-related Complications
timeFrame: From Month 0 to Month 6
measure: Number of Subjects With Influenza-related Complications
timeFrame: From Month 0 to Month 6
measure: Number of Subjects With Fatal Outcomes Due to Laboratory Confirmed Influenza Infection
timeFrame: From Month 0 to Month 6
measure: Number of Subjects With Fatal Outcomes
timeFrame: From Month 0 to Month 6
measure: Number of Subjects With Laboratory-confirmed Respiratory Syncytial Virus Infection (RSV)
timeFrame: From Month 0 to Month 6
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: From Month 0 to Month 6
measure: Number of Seroconverted Subjects for Each Influenza Strain
timeFrame: At Day 21
measure: Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease
timeFrame: At Day 21
measure: Number of Seroprotected Subjects Against the 3 Influenza Strains
timeFrame: At Day 0 (PRE)
measure: Number of Seroprotected Subjects Against the 3 Influenza Strains
timeFrame: At Day 21
measure: Number of Seropositive Subjects for Each Influenza Strain
timeFrame: At Day 0 (PRE)
measure: Number of Seropositive Subjects for Each Influenza Strain
timeFrame: At Day 21
measure: Serum HI Antibody Titers for Each Influenza Strain
timeFrame: At Day 0 (PRE)
measure: Serum HI Antibody Titers for Each Influenza Strain
timeFrame: At Day 21
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: GSK Investigational Site
state: Alabama
city: Delray Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: GSK Investigational Site
state: Florida
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Somers Point
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Camillus
country: United States
facility: GSK Investigational Site
state: New York
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Norfolk
country: United States
facility: GSK Investigational Site
state: Virginia
city: Gueglingen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Rudersberg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Weinheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Potsdam
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Frankfurt/Main
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Essen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Witten
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Rhaunen
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Magdeburg
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzg
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Utrecht
country: Netherlands
facility: GSK Investigational Site
city: Debica
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Mielec
country: Poland
facility: GSK Investigational Site
city: Porabka
country: Poland
facility: GSK Investigational Site
city: Siemianowice Slaskie
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: