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

NCT00505453 | Completed Phase 3

• 1 other identifier: 110502
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

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.

Conditions

Influenza

Keywords

Influenza

Outcome Measures

Primary Outcomes (1)

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

  21 days after vaccination

Secondary Outcomes (3)

• Evaluate safety & reactogenicity: Solicited AEs

  4 days

• Evaluate safety & reactogenicity: Unsolicited AEs

  21 days

• Evaluate safety & reactogenicity: SAEs

  entire study

Interventions

Fluviral® BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male and female adults, 18 years of age and older.
• Female subject of non-childbearing potential. Written informed consent obtained from subject.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Québec, Quebec, G1W 4R4, Canada

Location

GSK Investigational Site

Sherbrooke, Quebec, J1H 1Z1, Canada

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2007
• First Posted: July 23, 2007
• Study Start: July 1, 2007
• Study Completion: August 1, 2007
• Last Updated: November 4, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

CA (2)