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A Phase 3 Open-label Study to Evaluate the Safety of MEDI3250 in Healthy Japanese Children Age 2 Years Through 6 Years

NCT02269488 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2015-09-28

Study results available
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Summary

This open-label, single arm, multicenter study will enroll approximately 100 subjects. The study is designed to gather the safety and tolerability data in Japanese children 2 to 6 years of age that would support approval of MEDI3250 in Japan.

Conditions

  • Healthy Japanese Children Age 2 Years Through 6 Years

Interventions

DRUG

MEDI3250

MEDI3250

Sponsors & Collaborators

Principal Investigators

  • Shigeru Suga, MD · National Mie Hospital

  • Ochiai Hitoshi, MD · Ochiai Pediatrics Clinic

  • Watanabe Masahiro, MD · Suzuka Pediatrics Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • Japan

Study Locations

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Entities

Companies

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 NCT02269488 on ClinicalTrials.gov