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OpenTrials
Completed

NCT Number: NCT00505453

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

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Québec, Quebec, Canada

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fluviral®

Biological

Primary outcomes

  1. To evaluate the immunogenicity of Fluviral influenza vaccine in adults 18 years or older

    Time frame: 21 days after vaccination

Secondary outcomes

  1. Evaluate safety & reactogenicity: Solicited AEs

    Time frame: 4 days

  2. Evaluate safety & reactogenicity: Unsolicited AEs

    Time frame: 21 days

  3. Evaluate safety & reactogenicity: SAEs

    Time frame: entire study

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2007
Study completion
2007
First posted
Jul 23, 2007
Registry last updated
Nov 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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