Safety and Immunogenicity of MT-5625 in Healthy Adults, Toddlers and Infants

Phase 1 Completed 110 enrolled Tanabe Pharma Corporation

RandomizedParallel-groupOpen-labelPrevention

Summary

A study to investigate the safety and reactogenicity of MT-5625 independently in adults aged 18-35 years, toddlers ages 12-24 months, and infants aged 6-10 weeks

Timeline

Start: 2018-07-03
Primary completion: 2019-06-28
Completion: 2019-06-28

Publications

Kurokawa N, Robinson MK, Bernard C, Kawaguchi Y, Koujin Y, Koen A, Madhi S, Polasek TM, McNeal M, Dargis M, Couture MM, Trepanier S, Forrest BD, Tsutsui N. Safety and immunogenicity of a plant-derived rotavirus-like particle vaccine in adults, toddlers and infants. Vaccine. 2021 Sep 15;39(39):5513-5523. doi: 10.1016/j.vaccine.2021.08.052. Epub 2021 Aug 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MT-5625	Unknown	2.5 ug	Intramuscular
Subject	MT-5625	Unknown	7 ug	Intramuscular
Subject	MT-5625	Unknown	21 ug	Intramuscular
Comparator	Rotarix	Vaccine	—	Oral

Indications

No indication recorded.