Safety and Immunogenicity of FluLaval™ TR and Fluarix® (Influenza Vaccines) in Young and Older Adults
Completed · Phase 3
Conditions studied: Influenza
In brief
The purpose of this trial is to describe the immunogenicity, the safety, and tolerability of FluLaval™ TR and Fluarix®, the latter serving as active comparator. The results will be compared to a standard immune response criteria, for both young and elderly populations.
Key facts
- Study ID
- NCT00380211
- Run by
- GlaxoSmithKline
- People needed
- 660
- Starts
- 2006-09-01
- Expected to finish
- 2006-11-01
- Last updated by the study team
- 2016-10-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Male or female adults (≥18 yrs)
- Stable health status
- Provide informed consent
- Access to direct phone service (NOT a pay phone or a common-use phone service)
- Eligible females must have a negative pregnancy test
You may not qualify if…
- Febrile illness (>38.0°C oral temperature)
- High blood pressure (≥140/90 mmHg)
- Significant acute or chronic
- Uncontrolled medical or psychiatric illness within 1 month prior to vaccination
- Immunosuppressive condition (confirmed or suspected)
- Renal impairment
- Hepatic dysfunction
- Complicated insulin-dependent diabetes mellitus
- Unstable cardiopulmonary disease
- Blood dyscrasias
- Cytotoxic, immunosuppressive drug, or glucocorticoids use within 1 month of vaccination (nasal glucocorticoids allowed)
- History of demyelinating disease
- Active neurological disorder
- Significant alcohol or drug abuse
- Significant coagulation disorder (prophylactic antiplatelet medications allowed)
- Influenza vaccine administrated within 6 months prior to study vaccination
- Administration of any other vaccine from 30 days prior to the end of the study
- Use of non-registered drug within 30 days prior to study vaccination
- Receipt of immunoglobulins and/or any blood products within 3 months of study vaccination
- History or suspected allergy to previous influenza vaccine, or to any constituent of FluLaval™ TR and Fluarix®, or reaction to eggs consumption
- Pregnant or nursing female subjects
- Female subjects not protected by an acceptable contraception method (except if surgically sterile or post-menopausal)
Where it is running
- GSK Investigational Site — Miami, Florida, United States
- GSK Investigational Site — Lenexa, Kansas, United States
- GSK Investigational Site — Binghamton, New York, United States
- GSK Investigational Site — Austin, Texas, United States
- GSK Investigational Site — Fort Worth, Texas, United States
- GSK Investigational Site — Burke, Virginia, United States
Full record on ClinicalTrials.gov
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