Last updated: 11/03/2018 09:40:44
Study on the incidence of influenza and its complications, in subjects aged 50 years and over vaccinated with Fluarix™
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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™
Trial description: 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™
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Number of subjects with at least one influenza-like-infection (ILI) episode
Timeframe: From Month 0 to Month 6
Number of subjects with laboratory-confirmed influenza infection type A and/or type B
Timeframe: From Month 0 to Month 6
Number of subjects with hospitalization, emergency room visits, or unscheduled medical office visits due to ILI
Timeframe: From Month 0 to Month 6
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
Number of subjects with hospitalization or emergency room visit for any cause
Timeframe: From Month 0 to Month 6
Number of subjects with emergency room visits, or unscheduled medical office visits due to influenza-related complications
Timeframe: From Month 0 to Month 6
Number of subjects with influenza-related complications
Timeframe: From Month 0 to Month 6
Number of subjects with fatal outcomes due to laboratory confirmed influenza infection
Timeframe: From Month 0 to Month 6
Number of subjects with fatal outcomes
Timeframe: From Month 0 to Month 6
Number of subjects with laboratory-confirmed Respiratory Syncytial Virus infection (RSV)
Timeframe: From Month 0 to Month 6
Number of subjects with serious adverse events (SAEs)
Timeframe: From Month 0 to Month 6
Number of seroconverted subjects for each influenza strain
Timeframe: At Day 21
Seroconversion factor for Hemagglutination Inhibition (HI) antibodies against 3 strains of influenza disease
Timeframe: At Day 21
Number of seroprotected subjects against the 3 influenza strains
Timeframe: At Day 0 (PRE)
Number of seroprotected subjects against the 3 influenza strains
Timeframe: At Day 21
Number of seropositive subjects for each influenza strain
Timeframe: At Day 0 (PRE)
Number of seropositive subjects for each influenza strain
Timeframe: At Day 21
Serum HI antibody titers for each influenza strain
Timeframe: At Day 0 (PRE)
Serum HI antibody titers for each influenza strain
Timeframe: At Day 21
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: Fluarix™
Enrollment:
3054
Observational study model:
Not applicable
Primary completion date:
2007-20-06
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Influenza
Product
GSK576389A
Collaborators
Not applicable
Study date(s)
October 2006 to June 2007
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
50+ years
Accepts healthy volunteers
Yes
- A male or female age 50 years or older at the time of the first vaccination.
- non-childbearing female
- Use of non-registered products
- Pregnancy
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
Camillus, New York, United States, 13031
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
Status
Study Complete
Location
GSK Investigational Site
Norfolk, Virginia, United States, 23507
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27612
Status
Study Complete
Location
GSK Investigational Site
Gueglingen, Baden-Wuerttemberg, Germany, 74363
Status
Study Complete
Location
GSK Investigational Site
Pembroke Pines, Florida, United States, 33024
Status
Study Complete
Location
GSK Investigational Site
Rhaunen, Rheinland-Pfalz, Germany, 55624
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89104
Status
Study Complete
Location
GSK Investigational Site
Somers Point, New Jersey, United States, 08244
Status
Study Complete
Location
GSK Investigational Site
Weinheim, Baden-Wuerttemberg, Germany, 69469
Status
Study Complete
Location
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39112
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Status
Study Complete
Location
GSK Investigational Site
Frankfurt/Main, Hessen, Germany, 60596
Status
Study Complete
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45359
Status
Study Complete
Location
GSK Investigational Site
Delray Beach, Florida, United States, 33484
Status
Study Complete
Location
GSK Investigational Site
Rudersberg, Baden-Wuerttemberg, Germany, 73635
Status
Study Complete
Location
GSK Investigational Site
Witten, Nordrhein-Westfalen, Germany, 58455
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2007-20-06
Actual study completion date
2007-20-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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