NCT02661490 - Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine in an Elderly Population | Biotech Hunter

Enrollment

320

Participants

Timeline

Start Date

February 1, 2016

Primary Completion Date

October 28, 2016

Study Completion Date

September 29, 2017

Conditions

Norovirus

Interventions

BIOLOGICAL

Norovirus GI.1/GII.4 Bivalent VLP Vaccine

Norovirus GI.1/GII.4 bivalent VLP vaccine adjuvanted with aluminum hydroxide, without MPL for IM injection

DRUG

0.9% sodium chloride (saline)

norovirus bivalent placebo-matching vaccine

BIOLOGICAL

Norovirus GI.1/GII.4 Bivalent VLP Vaccine

Norovirus GI.1/GII.4 bivalent VLP vaccine adjuvanted with MPL and aluminum hydroxide for IM injection

Trial Locations (10)

Regional Clinical Research Inc., Endwell

University of Rochester, Rochester

Miami Research Associates, Miami

Simon Williamson Clinic, Birmingham

St. Louis University, School of Medicine, St Louis

Johnson County Clin-Trials, Lenexa

Southwest Family Medicine, Littleton

Fountain Hills Family Practice, P.C., Fountain Hills

Group Health Research Institute, Seattle

Cincinnati Childrens Hospital Medical Center, Cincinnati