Safety and Immunogenicity of Norovirus VLP Vaccine in Elderly

Phase 2, randomised, double-blind trial of NoV GI.1/GII.4 bivalent VLP vaccine in norovirus infection (5 arms), sponsored by Takeda. Primary endpoints: Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 and GII.4 Virus Like Particles (VLP) as Measured by Histoblood Group Antigen (HBGA)… at Day 57, Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 and 8 more. Started Feb 2016; status: completed.