Last updated: 11/03/2018 09:38:57

Study to evaluate the safety and immunogenicity of Fluarix™ 2006/2007 in adults aged 18 years or above

Request patient level data
GSK study ID
107507
See study documents
Clinicaltrials.gov ID
NCT00345904
EudraCT ID
2006-001918-33
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Phase III study for evaluation of immunogenicity and reactogenicity of Fluarix™ (Influsplit SSW®) 2006/2007 in people aged 18 years or above
Trial description: Vaccination is currently the most effective mean of controlling influenza and preventing its complications and mortality in persons at risk. Because of the variable nature of influenza viruses, the composition of influenza vaccines changes almost every year, to target the 3 main circulating strains. Each year the influenza vaccine formulation may thus be different and clinical studies are mandated to ensure that the immunogenicity and safety of the vaccine formulated from the three annual circulating strains are similar to what was observed during the previous years.
This study is designed to test the immunogenicity and reactogenicity of the Fluarix™ vaccine containing the influenza strains recommended for the 2006-2007 season.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: Fluarix
Enrollment:
120
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Influenza
Product
SB218352
Collaborators
Not applicable
Study date(s)
July 2006 to August 2006
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
  • A male or female aged 18 years or above at the time of the vaccination;
  • Healthy subjects or with well-controlled chronic diseases;
  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Inclusion and exclusion criteria
Inclusion criteria:
  • A male or female aged 18 years or above at the time of the vaccination;
  • Healthy subjects or with well-controlled chronic diseases;
  • If the subject is female, she must be of non-childbearing potential
Exclusion criteria:
  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
  • Administration of an influenza vaccine within 6 months preceding the study start.
  • Administration of an influenza vaccine other than the study vaccine during the entire study
  • Clinically or virologically confirmed influenza infection within 6 months preceding the study start
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Acute disease at the time of enrolment.
  • Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  • Not stabilized or clinically serious chronic underlying disease
  • Lactating female.
  • History of chronic alcohol consumption and/or drug abuse.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
  • Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Dresden, Sachsen, Germany, 01099
Status
Terminated/Withdrawn
Contact us
Location
GSK Investigational Site
Dresden, Sachsen, Germany, 01277
Status
Terminated/Withdrawn
Contact us
Location
GSK Investigational Site
Dresden, Sachsen, Germany, 01097
Status
Terminated/Withdrawn
Contact us
Location
GSK Investigational Site
Freital, Sachsen, Germany, 01705
Status
Terminated/Withdrawn
Contact us

Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2006-28-08

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

Participate in clinical trial
Additional information
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Click here
Access to clinical trial data by researchers
Visit website