NCT00711295

Phase 3 Study of a H5N1 Vaccine in Adults, Elderly and Specified Risk Groups

An Open-Label Phase 3 Study to Assess the Safety and Immunogenicity of a Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine in an Adult and Elderly Population as Well as in Specified Risk Groups

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,583 (actual)
• Sponsor: Alachua Government Services, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety and tolerability of, and the immune response to a non-adjuvanted H5N1 influenza vaccine in an adult and elderly population and in specified risk groups. Furthermore, persistence of H5N1 influenza antibodies after vaccination with this vaccine will be assessed.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	H5N1 Influenza Vaccine Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted	Intramuscular injection of 7.5 µg hemagglutinin antigen (A/Vietnam/1203/2004 strain) in a non-adjuvanted formulation on Days 0 and 21.
BIOLOGICAL	H5N1 Influenza Vaccine Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted	Intramuscular injection of 3.75 µg hemagglutinin antigen (A/Vietnam/1203/2004 strain) in a non-adjuvanted formulation on Days 0 and 21.

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-07-01
• Completion: 2010-10-01
• First posted: 2008-07-08
• Last updated: 2015-10-09

Locations

45 sites across 7 countries: Austria, Belgium, Finland, Germany, Latvia, Lithuania, Netherlands