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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00306982




Registration number
NCT00306982
Ethics application status
Date submitted
27/02/2006
Date registered
27/03/2006
Date last updated
12/10/2016

Titles & IDs
Public title
Incidence of Influenza, Downstream Complications of Influenza & Hospitalizations in Elderly Vaccinated With Fluarix™
Scientific 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.
Secondary ID [1] 0 0
106622
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Fluarix

Other interventions: Fluarix
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes

Eligibility
Key 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.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2006
Sample size
Target
Accrual to date
Final
1524
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,TAS,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Garran
Recruitment hospital [2] 0 0
GSK Investigational Site - Umina
Recruitment hospital [3] 0 0
GSK Investigational Site - Auchenflower
Recruitment hospital [4] 0 0
GSK Investigational Site - Kippa Ring
Recruitment hospital [5] 0 0
GSK Investigational Site - South Brisbane
Recruitment hospital [6] 0 0
GSK Investigational Site - Hobart
Recruitment hospital [7] 0 0
GSK Investigational Site - Clayton
Recruitment hospital [8] 0 0
GSK Investigational Site - Heidelberg Heights
Recruitment hospital [9] 0 0
GSK Investigational Site - Parkville
Recruitment hospital [10] 0 0
GSK Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2606 - Garran
Recruitment postcode(s) [2] 0 0
2257 - Umina
Recruitment postcode(s) [3] 0 0
4066 - Auchenflower
Recruitment postcode(s) [4] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
- Hobart
Recruitment postcode(s) [7] 0 0
3168 - Clayton
Recruitment postcode(s) [8] 0 0
3084 - Heidelberg Heights
Recruitment postcode(s) [9] 0 0
3050 - Parkville
Recruitment postcode(s) [10] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Paraná
Country [2] 0 0
Brazil
State/province [2] 0 0
São Paulo

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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™.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00306982
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00306982