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Exploratory Clinical Study of MT-2301

NCT02140047 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2026-03-17

Study results available
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Summary

The purpose of this study is to evaluate efficacy and safety of MT-2301 when co-administered with DPT-IPV using ActHIB® as a control in healthy infants.

Conditions

  • Haemophilus Influenza Type b

Interventions

BIOLOGICAL

Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate)-Low + DPT-IPV

0.25mL, subcutaneous injection

BIOLOGICAL

Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate)-High + DPT-IPV

0.5mL, subcutaneous injection

BIOLOGICAL

Haemophilus influenza type b conjugate vaccine + DPT-IPV

0.5mL, subcutaneous injection

Sponsors & Collaborators

  • Tanabe Pharma Corporation

    lead INDUSTRY

Principal Investigators

  • Takashi Nakano, M.D., Ph.D. · Department of pediatrics, Kawasaki Hospital, Kawasaki Medical School

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
7 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-01-31
Completion
2015-09-30

Countries

  • Japan

Study Locations

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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 NCT02140047 on ClinicalTrials.gov