MedTrace Logo

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

NCT03507738 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2019-08-06

No results posted yet for this study

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

Conditions

  • Healthy

Interventions

BIOLOGICAL

MT-5625 low dose

Intramuscular injection

BIOLOGICAL

MT-5625 middle dose

Intramuscular injection

BIOLOGICAL

MT-5625 high dose

Intramuscular injection

BIOLOGICAL

Rotarix

Oral administration

BIOLOGICAL

Placebo

Intramuscular injection

Sponsors & Collaborators

  • Mitsubishi Tanabe Pharma Corporation

    lead INDUSTRY

Principal Investigators

  • General Manager · Mitsubishi Tanabe Pharma Corporation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Australia
  • South Africa

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03507738 on ClinicalTrials.gov