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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

July 20, 2007

Last Updated Date

October 15, 2008

Start Date ^†

July 2007

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00505453 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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

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

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Prevention, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Influenza

Intervention ^†

Biological: Fluviral®

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

110

Completion Date

Primary Completion Date

Eligibility 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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Canada

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00505453

Responsible Party

Study Director, GSK

Secondary IDs ^††

Study Sponsor ^†

GlaxoSmithKline

Collaborators ^††

Investigators ^†

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.