drugset / Trial / NCT02768805

Immunogenicity of a Quadrivalent Virus-Like Particles (VLP) Influenza Vaccine in Healthy Adults

NCT02768805

Phase 2 Completed 900 enrolled Medicago
RandomizedParallel-groupSingle-blindPrevention

Summary

This Phase 2 Quadrivalent VLP Vaccine study is intended to replicate and extend the immunogenicity and safety results obtained in earlier Phase 1-2 and Phase 2 studies. The study is being conducted to demonstrate that the immunogenicity profile of the Quadrivalent VLP Vaccine meets the US Center for Biologics Evaluation and Research (CBER) licensure criteria. The study will also help to define the optimal dose, establish potential competitive advantages, and support the design of future studies.

Timeline

Start
2016-03-02
Primary completion
2016-05-17
Completion
2016-11-26

Drugs

EvaluationDrugModalityDoseRoute
Comparator FluLaval® Quadrivalent Vaccine 15 ug Intramuscular
Subject Quadrivalent VLP Vaccine Vaccine 15 ug Intramuscular
Subject Quadrivalent VLP Vaccine Vaccine 30 ug Intramuscular