NCT00903552

Trial to Evaluate Safety and Immunogenicity of Trivalent Seasonal Influenza Virus-Like Particle (VLP) Vaccine (Recombinant)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 221 (actual)
• Sponsor: Novavax · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

This is a phase 2A randomized, double blind, placebo controlled trial to evaluate the safety and immunogenicity of a trivalent seasonal influenza virus-like particle (VLP) vaccine (recombinant) in healthy adults.

Detailed description

The primary study objectives are: * To assess the tolerability and safety of the Influenza VLP Vaccine * To assess the immunogenicity of the Influenza VLP Vaccine as measured by hemagglutination inhibition (HAI) antibody titers to each of the component viral strains

Conditions

• Seasonal Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Influenza VLP Vaccine
BIOLOGICAL	Placebo	phosphate-buffered saline (PBS)

Timeline

• Start date: 2009-05-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2009-05-18
• Last updated: 2013-07-18

Locations

2 sites across 1 country: United States