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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

July 20, 2007
October 15, 2008
July 2007
Not Provided
To evaluate the immunogenicity of Fluviral influenza vaccine in adults 18 years or older [ Time Frame: 21 days after vaccination ]
Same as current
Complete list of historical versions of study NCT00505453 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Phase III, Open-Label, Single-Dose Study to Evaluate the Safety and Immunogenicity of Fluviral® Vaccine
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

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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Influenza
Biological: Fluviral®
Other Name: Fluviral®
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
Not Provided
Not Provided

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00505453
110502
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP