NCT01014806

Evaluate the Safety and Immunogenicity of a Seasonal Influenza Virus-Like Particle (VLP) Vaccine in Older Adults

A Phase 2a Randomized, Double-Blind, Active-Controlled Trial to Evaluate the Safety and Immunogenicity of a Trivalent Seasonal Influenza Virus-Like Particle (VLP) Vaccine (Recombinant) in Older Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 467 (actual)
• Sponsor: Novavax · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

* To assess the tolerability and safety of a single injection of Influenza VLP Vaccine when administered intramuscularly (IM) at 15 µg and 60 µg HA per each strain. * To assess the immunogenicity of Influenza VLP Vaccine administered at 15 µg and 60 µg HA per strain as measured by hemagglutination inhibition (HAI) antibody titers to each of the component viral strains \[A/Brisbane/59/2007 (H1N1); A/Brisbane/10/2007 (H3N2) and B/Brisbane/60/2008\].

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Influenza VLP Vaccine	Single dose; 0.5mL
BIOLOGICAL	TIV	Trivalent Influenza Vaccine 15ug/strain, commercially licensed

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2009-11-17
• Last updated: 2013-07-18

Locations

6 sites across 1 country: United States