Safety and Immunogenicity of Norovirus Bivalent Virus-Like Particle Vaccine in Healthy Adults

PHASE2CompletedINTERVENTIONAL
Enrollment

454

Participants

Timeline

Start Date

May 15, 2014

Primary Completion Date

January 6, 2016

Study Completion Date

January 6, 2016

Conditions
Norovirus Prevention
Interventions
BIOLOGICAL

Norovirus Bivalent VLP Vaccine

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

DRUG

Placebo (Saline)

Placebo-matching norovirus bivalent VLP vaccine

Trial Locations (10)

14609

Rochester Clinical Research, Rochester

14642

University of Rochester, Rochester

21201

SNBL, Baltimore

33134

Clin Research of South Florida, Coral Gables

45206

Cincinnati Childrens Hospital Medical Center, Cincinnati

63104

St. Louis University, School of Medicine, St Louis

78705

Benchmark Research Austin, Austin

94108

Benchmark Research San Francisco, San Francisco

92103-6204

California Research Foundation, San Diego

77030-3498

Baylor College of Medicine, Houston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Takeda

INDUSTRY

NCT02142504 - Safety and Immunogenicity of Norovirus Bivalent Virus-Like Particle Vaccine in Healthy Adults | Biotech Hunter | Biotech Hunter