NCT00586469

A Randomized Study to Compare the Safety and Immunogenicity of Fluviral® Made With New Versus Aged Bulk

Observer-blind, Post-Marketing Study to Compare the Safety and Immunogenicity of Fluviral® Trivalent Split Virion Influenza Vaccine (2007-2008 Season) Made With New vs. Aged Bulk Material, in Adults Ranging in Age From 18 to 60 Years

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,000 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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 World Health Organization (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. For the strains which do not change from the previous year, the vaccine can be formulated from the old mono bulk from the previous year. Bulks as old as 12 months may be blended to make trivalent inactivated vaccine (TIV) under the current Canadian and US licenses. This study is conducted to evaluate safety and immunogenicity of Fluviral vaccines made with the aged bulk material compared with the new bulk material. This protocol posting has been updated in order to comply with the FDA Amendment Act, Sept 2007.

Conditions

• Influenza Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	Fluviral	One dose, Intramuscular injection

Timeline

• Start date: 2007-12-14
• Primary completion: 2008-01-14
• Completion: 2008-01-14
• First posted: 2008-01-04
• Last updated: 2019-06-27
• Results posted: 2009-05-28

Locations

8 sites across 1 country: Canada