NCT00561184

Safety and Immunogenicity of a Booster Dose of -H5N1 Influenza Vaccine

A Phase II, Open-label, Multi-Center Study to Evaluate Safety and Immunogenicity of a Booster Dose of -H5N1 (Surface Antigen Adjuvanted With MF59C.1) Influenza Vaccine in Non-elderly Adult and Elderly Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

To assess persistence of antibody titers 17-18 months after primary immunization with two 0.5mL intramuscular (IM) doses of H5N1 influenza vaccine containing H5N1 influenza antigen, as measured by Hemagglutination Inhibition (HI), Single Radial Hemolysis (SRH), and Microneutralization (MN) test

Conditions

• Avian Influenza

Interventions

Type	Name	Description
BIOLOGICAL	H5N1 influenza vaccine	One 0.5 ml booster injection 12 months after the second injection, of influenza vaccine containing 7.5 micrograms of H5N1 influenza antigen
BIOLOGICAL	H5N1 influenza vaccine	One 0.5 ml booster injection 12 months after the second injection, of influenza vaccine containing 15.0 micrograms of H5N1 influenza antigen

Timeline

• Start date: 2007-10-01
• Primary completion: 2007-12-01
• Completion: 2008-06-01
• First posted: 2007-11-20
• Last updated: 2016-12-01

Locations

3 sites across 1 country: Italy