NCT01063088

Adult Safety Study of 2009/2010 Seasonal Influenza Vaccine

An Open Label, Phase 3 Study to Assess the Safety and Immunogenicity of a Vero Cell-Derived Trivalent Seasonal Influenza Vaccine, Strain Composition 2009/2010, in an Adult Population

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 211 (actual)
• Sponsor: Alachua Government Services, Inc. · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to verify the safety and immunogenicity of a trivalent seasonal influenza vaccine with strain composition according to World Health Organization (WHO)/European Union (EU) recommendation for the 2009/2010 season.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Seasonal influenza vaccine (split virion, inactivated, prepared in Vero Cell cultures)	Single 0.5 mL intramuscular injection

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-03-01
• Completion: 2010-07-01
• First posted: 2010-02-05
• Last updated: 2015-10-09

Locations

2 sites across 2 countries: Austria, Belgium