drugset / Trial / NCT02661490

Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine in an Elderly Population

NCT02661490 ↗

Phase 2 Completed 320 enrolled Takeda
RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of this study is to further develop a formulation and dose regimen of the norovirus GI.1/GII.4 bivalent virus-like particle (VLP) vaccine that is immunogenic and safe in an elderly population aged 60 years and above.

Timeline

Start
2016-02-01
Primary completion
2016-10-28
Completion
2017-09-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Norovirus GI.1/GII.4 Bivalent VLP Vaccine Vaccine 15 ug Intramuscular
Subject Norovirus GI.1/GII.4 Bivalent VLP Vaccine Vaccine 15 ug Intramuscular
Subject Norovirus GI.1/GII.4 Bivalent VLP Vaccine Vaccine 50 ug Intramuscular
Subject Norovirus GI.1/GII.4 Bivalent VLP Vaccine Vaccine 50 ug Intramuscular