drugset / Trial / NCT01147068

Safety and Immunogenicity of PanBlok Influenza Vaccine in Healthy Adults

NCT01147068

Phase 1/2 Completed 392 enrolled Protein Sciences Corporation
RandomizedSingle-groupQuadruple-blindPrevention

Summary

The purpose of this study is to investigate the safety and immunogenicity of a recombinant hemagglutinin (rHA) influenza vaccine derived from A/Indonesia/05/2005 (H5N1) administered at 4 dose levels in adjuvanted (GLA-SE) rHA formulations and 2 dose levels in unadjuvanted rHA formulations.

Timeline

Start
2010-06
Primary completion
2011-10
Completion
2011-10

Drugs

EvaluationDrugModalityDoseRoute
Subject 0.5mL Intramuscular Injection Vaccine 3.8 ug Intramuscular
Subject 0.5mL Intramuscular Injection Vaccine 7.5 ug Intramuscular
Subject 0.5mL Intramuscular Injection Vaccine 15 ug Intramuscular
Subject 0.5mL Intramuscular Injection Vaccine 45 ug Intramuscular
Subject 0.5mL Intramuscular Injection Vaccine 135 ug Intramuscular
Subject Glucopyranosyl Lipid A Unknown 1 ug Intramuscular

Indications