drugset / Trial / NCT01302990

Safety, Tolerability and Immunogenicity of a Plant-Made H1 VLP Influenza Vaccine in Adults

NCT01302990

Phase 1 Completed 100 enrolled Medicago
RandomizedParallel-groupQuadruple-blindPrevention

Summary

This is a Phase 1, randomized, double-blind, active- and placebo-controlled, multicenter, dose-ranging study to evaluate the safety, tolerability and Immunogenicity of a single non-adjuvanted dose of the H1 VLP Influenza vaccine in healthy adults 18-49 years of age.

Timeline

Start
2011-02
Primary completion
2011-07
Completion
2011-11

Drugs

EvaluationDrugModalityDoseRoute
Subject H1 VLP Vaccine 5 ug Intramuscular
Subject H1 VLP Vaccine 13 ug Intramuscular
Subject H1 VLP Vaccine 28 ug Intramuscular
Subject Influenza Virus Vaccine Vaccine 45 ug Intramuscular

Indications