NCT00831987

Safety and Immunogenicity of the World Health Organization (WHO) Formulation of the 2004-2005 Fluzone® Vaccine

Annual Study of Safety and Immunogenicity of Influenza Virus Vaccine Fluzone® 2004-2005

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To observe and to describe the safety during Days 0 to 21 following injection of the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone® in subjects aged 18-59 years and subjects aged ≥ 60 years. To measure and to describe the immune response (antibodies to hemagglutinin) 21 days following injection of the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone®, in subjects aged 18-59 years and subjects aged ≥ 60 years.

Detailed description

The time of onset and duration of local and systemic solicited reactions will be assessed and reported. Unsolicited adverse events (including serious adverse events) will be collected and categorized throughout the study period. Antibody levels will be evaluated by hemagglutination inhibition (HI) assay from sera obtained pre-vaccination (Day 0) and 21 days post-vaccination, for antigens from the 2004-2005 influenza virus strains: A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2), and B/Jiangsu/10/2003.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Fluzone®: Influenza virus vaccine 2004-2005 formulation	0.5 mL, Intramuscular
BIOLOGICAL	Fluzone®: Influenza virus vaccine 2004-2005 formulation	0.5 mL, Intramuscular

Timeline

• Start date: 2004-08-01
• Primary completion: 2006-02-01
• Completion: 2006-02-01
• First posted: 2009-01-29
• Last updated: 2016-04-14
• Results posted: 2009-08-27

Locations

1 site across 1 country: United States