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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00505453
• Other study ID #: 110502
• Status: Completed
• Phase: Phase 3
• First received: July 20, 2007
• Last updated: November 3, 2016
• Start date: July 2007
• Est. completion date: August 2007

Study information

• Verified date: November 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: August 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Fluviral®

Locations

Country	Name	City	State
Canada	GSK Investigational Site	Quebec
Canada	GSK Investigational Site	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the immunogenicity of Fluviral influenza vaccine in adults 18 years or older		21 days after vaccination
Secondary	Evaluate safety & reactogenicity: Solicited AEs		4 days
Secondary	Evaluate safety & reactogenicity: Unsolicited AEs		21 days
Secondary	Evaluate safety & reactogenicity: SAEs		entire study

External Links

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