drugset / Trial / NCT01014806

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

NCT01014806 ↗

Phase 2 Completed 467 enrolled Novavax
RandomizedParallel-groupQuadruple-blindPrevention

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 \[A/Brisbane/59/2007 (H1N1); A/Brisbane/10/2007 (H3N2) and B/Brisbane/60/2008\].

Timeline

Start
2009-11
Primary completion
2010-05
Completion
2010-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Influenza VLP Vaccine Vaccine 15 ug Intramuscular
Subject Influenza VLP Vaccine Vaccine 60 ug Intramuscular
Comparator TIV Vaccine 15 ug —

Indications