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

Phase 3

Completed

• Conditions: Influenza

• Registration Number: NCT00505453
• Lead Sponsor: GlaxoSmithKline

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-07-20
• Study First Submitted QC: 2007-07-20
• Study First Posted: 2007-07-23
• Study Completion: 2007-08
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-03
• Last Update Posted: 2016-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To evaluate the immunogenicity of Fluviral influenza vaccine in adults 18 years or older	21 days after vaccination

Secondary Outcome Measures

Name	Time	Method
Evaluate safety & reactogenicity: Unsolicited AEs	21 days
Evaluate safety & reactogenicity: SAEs	entire study
Evaluate safety & reactogenicity: Solicited AEs	4 days

Trial Locations

Locations (1)

GSK Investigational Site; 🇨🇦 Quebec, Canada