Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent VLP Vaccine

NCT02038907 ↗

Phase 2 Completed 420 enrolled Takeda

RandomizedFactorialQuadruple-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), Aluminum Hydroxide and MPL adjuvant (3-O-desacyl-4'-monophosphoryl lipid A) for further development.

Timeline

Start: 2014-03-28
Primary completion: 2015-06-19
Completion: 2015-06-19

Publications

Leroux-Roels G, Cramer JP, Mendelman PM, Sherwood J, Clemens R, Aerssens A, De Coster I, Borkowski A, Baehner F, Van Damme P. Safety and Immunogenicity of Different Formulations of Norovirus Vaccine Candidate in Healthy Adults: A Randomized, Controlled, Double-Blind Clinical Trial. J Infect Dis. 2018 Jan 30;217(4):597-607. doi: 10.1093/infdis/jix572.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Norovirus Bivalent VLP Vaccine	Vaccine	15 ug	Intramuscular
Subject	Norovirus Bivalent VLP Vaccine	Vaccine	50 ug	Intramuscular
Subject	Norovirus Bivalent VLP Vaccine	Vaccine	150 ug	Intramuscular
Background	Havrix	Vaccine	—	Intramuscular

Indications

No indication recorded.