Skip to main content
MedPathMedPath Home
Clinical Trials/NCT00505453
NCT00505453
Completed
Phase 3

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

GlaxoSmithKline1 site in 1 country110 target enrollmentJuly 2007
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsInfluenza

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Influenza
Sponsor
GlaxoSmithKline
Enrollment
110
Locations
1
Primary Endpoint
To evaluate the immunogenicity of Fluviral influenza vaccine in adults 18 years or older
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2007
End Date
August 2007
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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

Time Frame: 21 days after vaccination

Secondary Outcomes

  • Evaluate safety & reactogenicity: Unsolicited AEs(21 days)
  • Evaluate safety & reactogenicity: SAEs(entire study)
  • Evaluate safety & reactogenicity: Solicited AEs(4 days)

Study Sites (1)

Loading locations...

Similar Trials

Completed
Phase 3
Study to Evaluate the Safety and Immunogenicity of Fluarix™ 2006/2007 in Adults Aged 18 Years or AboveInfluenza
NCT00345904GlaxoSmithKline120
Completed
Phase 4
A Randomized Study to Compare the Safety and Immunogenicity of Fluviral® Made With New Versus Aged BulkInfluenza Vaccines
NCT00586469GlaxoSmithKline1,000
Completed
Not Applicable
Vaccine Health Literacy Related Text Message Reminders to Increase Receipt of Second Dose of Influenza Vaccine for Young, Low Income, Urban ChildrenInfluenza
NCT01662583Columbia University660
Completed
Phase 3
Safety and Immunogenicity of Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2010/2011, When Administered to Adult and Elderly SubjectsSeasonal Influenza
NCT01161264Novartis Vaccines126
Completed
Phase 3
Second Extension Study to Evaluate Safety and Tolerability of Influenza Vaccines in Adults and Elderly, and to Evaluate Immunogenicity and Concomitant Vaccination With Pneumococcal Vaccine in a SubgroupInfluenza
NCT00579345Novartis1,522