Status:
COMPLETED
Safety and Immunogenicity of FluLaval™ TR and Fluarix® (Influenza Vaccines) in Young and Older Adults
Lead Sponsor:
GlaxoSmithKline
Conditions:
Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 stand...
Detailed Description
This randomized trial will assess the immune protection offered at Day 21 by FluLaval™ TR, Fluarix® being the comparator. In both groups, immune response will be assessed through a blood test before a...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
660 Patients enrolled
Trial Details
Trial ID
NCT00380211
Start Date
September 1 2006
End Date
November 1 2006
Last Update
October 7 2016
Active Locations (6)
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1
GSK Investigational Site
Miami, Florida, United States, 33173
2
GSK Investigational Site
Lenexa, Kansas, United States, 66219
3
GSK Investigational Site
Binghamton, New York, United States, 13901
4
GSK Investigational Site
Austin, Texas, United States, 78705