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

Seasonal Influenza Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00903552
Study type Interventional
Source Novavax
Contact
Status Completed
Phase Phase 2
Start date May 2009
Completion date October 2009
View Details
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