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A Phase III, Open-Label, Single-Dose Study to Evaluate the Safety and Immunogenicity of Fluviral® Vaccine

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00505453
First received: July 20, 2007
Last updated: October 15, 2008
Last verified: October 2008
History of Changes
  Purpose

Vaccination is currently the most effective means of controlling influenza and preventing its complications and mortality in persons at risk.

Once a year, a meeting of WHO experts takes place, leading to a recommendation on the influenza A and B strains that should be used for the production of vaccine for the coming influenza season.

This study is designed to test the safety/reactogenicity and the immunogenicity of the Fluviral Trivalent Split Virion Influenza Vaccine containing the influenza strains recommended for the 2007-2008 season.


Condition Intervention Phase
Influenza
 Biological: Fluviral®
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase III, Open-Label, Single-Dose Study to Evaluate the Safety and Immunogenicity of Fluviral® Trivalent Split Virion Influenza Vaccine (2007 - 2008 Season) in Adults Ranging in Age From 18 to 60 Years and 61 Years and Over

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • To evaluate the immunogenicity of Fluviral influenza vaccine in adults 18 years or older [ Time Frame: 21 days after vaccination ]

Secondary Outcome Measures:
  • Evaluate safety & reactogenicity: Solicited AEs [ Time Frame: 4 days ]
  • Evaluate safety & reactogenicity: Unsolicited AEs [ Time Frame: 21 days ]
  • Evaluate safety & reactogenicity: SAEs [ Time Frame: entire study ]

Estimated Enrollment: 110
Study Start Date: July 2007
Intervention Details:
    Biological: Fluviral®
    Other Name: Fluviral®
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and female adults, 18 years of age and older.
  • Female subject of non-childbearing potential. Written informed consent obtained from subject.

Exclusion Criteria:

  • Acute disease at the time of enrollment.
  • Blood pressure abnormalities.
  • Any immunosuppressive condition, such as HIV or cancer.
  • Renal impairment, hepatic dysfunction, complicated insulin-dependent diabetes mellitus.
  • Unstable cardiopulmonary disease requiring chronic medical therapy or associated with functional impairment.
  • Any demyelinating disease, including Guillain-Barré syndrome.
  • Alcohol consumption and/or drug abuse.
  • Receipt of an influenza vaccine within 9 months prior to enrollment or of any vaccines within 30 days prior to enrollment.
  • Any known or suspected allergy to the Fluviral vaccine.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00505453

Locations
Canada, Quebec
GSK Investigational Site
Sherbrooke, Quebec, Canada, J1H 1Z1
Canada
GSK Investigational Site
Quebec, Canada, G1W 4R4
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00505453     History of Changes
Other Study ID Numbers: 110502
Study First Received: July 20, 2007
Last Updated: October 15, 2008
Health Authority: Canada: Health Canada

Keywords provided by GlaxoSmithKline:
Influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013