Last updated: 11/03/2018 09:05:19
Incidence of influenza, downstream complications of influenza & hospitalizations in elderly vaccinated with Fluarix™
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: An observational study to investigate the incidence of influenza, downstream complications of influenza and hospitalizations, in elderly subjects vaccinated with GSK Biologicals’ influenza vaccine (Fluarix™) administered intramuscularly.
Trial description: This study will investigate the incidence of influenza, disease and various possible downstream complications and hospitalizations or emergency room visits after routine annual vaccination of the elderly population with Fluarix™.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: Fluarix
Enrollment:
1524
Observational study model:
Not applicable
Primary completion date:
2006-14-12
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Influenza
Product
GSK2647158A, GSK576389A
Collaborators
Not applicable
Study date(s)
March 2006 to December 2006
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
65+ years
Accepts healthy volunteers
Yes
- Inclusion Criteria
- All subjects must satisfy to the following criteria at study entry:
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion Criteria All subjects must satisfy to the following criteria at study entry:
- (1) A male or female age 65 years at the time of the first vaccination,
- (2) Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., return for follow-up visits, disease reporting by phone, and completion of Questionnaires) should be enrolled in the study
- (3) Written informed consent obtained from the subject
- (4) Availability to follow up by phone during the study period
- (5) Subjects with residence status allowing free mixing with general community. Exclusion Criteria The subject must not be included in the study for:
- (1) history of hypersensitivity to a previous dose of influenza vaccine
- (2) history of allergy or reactions likely to be exacerbated by any component of the vaccine including egg, chicken protein, formaldehyde, thimerosal, gentamicin sulfate or sodium deoxycholate,
- (3) use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Trial location(s)
Location
GSK Investigational Site
Heidelberg Heights, Victoria, Australia, 3084
Status
Study Complete
Location
GSK Investigational Site
Nedlands, Western Australia, Australia, 6009
Status
Study Complete
Location
GSK Investigational Site
Garran, Australian Capital Territory, Australia, 2606
Status
Study Complete
Location
GSK Investigational Site
Umina, New South Wales, Australia, 2257
Status
Study Complete
Location
GSK Investigational Site
Curitiba/Paraná, Paraná, Brazil, 80810-050
Status
Study Complete
Location
GSK Investigational Site
Kippa Ring, Queensland, Australia, 4021
Status
Study Complete
Location
GSK Investigational Site
Auchenflower, Queensland, Australia, 4066
Status
Terminated/Withdrawn
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, 04020050
Status
Study Complete
Location
GSK Investigational Site
South Brisbane, Queensland, Australia, 4101
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
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2006-14-12
Actual study completion date
2006-14-12
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
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Additional information
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