drugset / Trial / NCT02153112

Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle (VLP) Vaccine in Children

NCT02153112

Phase 2 Completed 840 enrolled Takeda
RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of this study is to select the optimal formulation of the norovirus vaccine from different concentrations of virus-like particles (VLP) combined with aluminum hydroxide for further development in children.

Timeline

Start
2015-06-23
Primary completion
2018-06-20
Completion
2018-06-20

Drugs

EvaluationDrugModalityDoseRoute
Subject HIL-214 Vaccine 15 ug Intramuscular
Subject HIL-214 Vaccine 50 ug Intramuscular
Subject HIL-214 Vaccine 150 ug Intramuscular
Background Aluminum hydroxide Unknown 500 ug Intramuscular