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CompletedNCT00345904Updated Sep 28, 2016

Study to Evaluate the Safety and Immunogenicity of Fluarix™ 2006/2007 in Adults Aged 18 Years or Above

A Phase 3 interventional study of Fluarix in Influenza, sponsored by GlaxoSmithKline. Completed at 4 sites in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-28.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
120
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study summary

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.

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Conditions studied

  • Influenza

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Keywords

  • influenza, vaccine
  • prophylaxis of influenza
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In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 164 are open to participants now.

This study's enrollment of 120 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
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Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants

Interventions

  • BiologicalFluarix
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What researchers measure

Primary outcomes

  1. to evaluate the humoral immune response in terms of anti-Haemmagglutinin antibodies 21 days post-vaccination

Secondary outcomes

  1. To evaluate the safety and reactogenicity of the vaccine in term of solicited local and general adverse events, unsolicited adverse events and serious adverse events

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Study locations

4 sites
  • GSK Investigational Site
    Dresden, Sachsen 01097, Germany
  • GSK Investigational Site
    Dresden, Sachsen 01099, Germany
  • GSK Investigational Site
    Dresden, Sachsen 01277, Germany
  • GSK Investigational Site
    Freital, Sachsen 01705, Germany
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References and documents

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00345904
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Jun 29, 2006
Start date
Jul 2006
Completion
Aug 2006
Last update
Sep 28, 2016

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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