Last updated: 11/07/2018 17:21:04

Safety and Immunogenicity of FluLaval™ TR and Fluarix® (Influenza vaccines) in young and older adults

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GSK study ID
IDB-200-001
See study documents
Clinicaltrials.gov ID
NCT00380211
EudraCT ID
Not applicable
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 Randomized, Double-Blind Trial Evaluating the Safety and Immunogenicity of an Influenza Vaccine with reduced Preservative (FluLaval™ TR) and a Standard Influenza Vaccine (Fluarix®) in subjects between 18-60 and Over 60 Years of Age.
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: Influenza vaccine (A/H3N2, A/H1N1, and B strains)
Biological/vaccine: Fluarix
Enrollment:
660
Observational study model:
Not applicable
Primary completion date:
2006-30-11
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Influenza
Product
Influenza Vaccine (Split Virion, Inactivated, Fluviral)
Collaborators
Not applicable
Study date(s)
September 2006 to November 2006
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
  • Male or female adults (≥18 yrs)
  • Stable health status
  • Febrile illness (>38.0°C oral temperature)
  • High blood pressure (≥140/90 mmHg)
Inclusion and exclusion criteria
Inclusion criteria:
  • 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 criteria:
  • 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)

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Binghamton, New York, United States, 13901
Status
Recruiting
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Location
GSK Investigational Site
Burke, Virginia, United States, 22015
Status
Recruiting
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Location
GSK Investigational Site
Fort Worth, Texas, United States, 76135
Status
Recruiting
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Location
GSK Investigational Site
Lenexa, Kansas, United States, 66219
Status
Recruiting
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Location
GSK Investigational Site
Austin, Texas, United States, 78705
Status
Recruiting
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Location
GSK Investigational Site
Miami, Florida, United States, 33173
Status
Recruiting
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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
2006-30-11
Actual study completion date
2006-30-11

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

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