NCT00522236

Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2007/2008) When Administered to Elderly Subjects

A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008, When Administered to Elderly Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged 65 years and over

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008	A single 0.5mL dose of Novartis adjuvanted subunit influenza vaccine, Fluad contained 45μg of viral hemagglutinin, composed of 15μg of the three influenza antigens: * A(H1N1) strain: IVR-145 (Solomon Island/3/2006 - like strain) * A(H3N2) strain: NYMC X-161B (A/Wisconsin/67/2005-like strain) * B strain: (B/Malaysia/2506/2004-like strain) in accordance with the recommendations of the World Health Organization, the EU and the national Regulatory Agencies for the 2007/2008 season. The vaccine is a milky liquid, and was packaged in ready to use, single dose syringes. A single dose of FLUAD vaccine was administered intramuscularly, preferably in the deltoid muscle of the non dominant arm.

Timeline

• Start date: 2007-06-01
• Primary completion: 2007-07-01
• Completion: 2007-07-01
• First posted: 2007-08-29
• Last updated: 2012-01-25

Locations

2 sites across 1 country: Italy