A Phase 1, Randomized, Placebo-controlled, Descending Age, Dose-escalation Study to Assess the Safety and Immunogenicity of an Investigational Non-Replicating Rotavirus Vaccine (MT-5625) in Healthy Adults, Toddlers and Infants
Sponsor study identifier
interventional
110
2 countries
2
Study Start
July 3, 2018
Actual (reported)Primary Completion
June 28, 2019
Actual (reported)Study Completion
June 28, 2019
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 28, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 15, 2018
Actual (reported)April 25, 2018
Actual (reported)July 3, 2018
Actual (reported)June 28, 2019
Actual (reported)June 28, 2019
Actual (reported)Proportion of subjects with local reactions and reactogenicity events.
Within 7 days after each vaccination
Proportion of subjects reporting adverse events.
Within 28 days after each vaccination
Proportion of subjects with anti-MT-5625 IgG seroresponses
Day 28 after each vaccination
Proportion of subjects with neutralizing antibody responses
Day 28 after each vaccination
Anti-MT-5625 IgG geometric mean titers (GMTs) 28 days after each injection in adults, toddlers, and infants.
Day 28 after each vaccination
Neutralizing antibody GMTs against rotavirus 28 days after each injection in adults, toddlers and infants.
Day 28 after each vaccination
Adult receiving intramuscular injection with either middle dose of MT-5625 or placebo
Adult receiving intramuscular injection with either high dose of MT-5625 or placebo
Intramuscular injection
Intramuscular injection
Investigational center
Adelaide, Australia
Investigational center
Johannesburg, South Africa
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.
General Manager
Tanabe Pharma Corporation
110 participants (actual enrollment reported by the registry).
First Submitted
April 15, 2018
First Posted
April 25, 2018
Study Start
July 3, 2018
Actual (reported)A Study to Investigate the Safety, Tolerability and Pharmacokinetics of MT-6345 in Healthy Subjects
Toddler receiving intramuscular injection with either middle dose of MT-5625 or placebo
Toddler receiving intramuscular injection with either high dose of MT-5625 or placebo
Infant receiving intramuscular injection with either low dose of MT-5625 or placebo
Infant receiving intramuscular injection with either middle dose of MT-5625 or placebo
Infant receiving intramuscular injection with either high dose of MT-5625 or placebo
Infant receiving oral administration with Rotarix
Intramuscular injection
Oral administration
Intramuscular injection
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
June 28, 2019
Actual (reported)Study Completion
June 28, 2019
Actual (reported)Last Updated
August 6, 2019
Record last verified: 2019-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: