Exploratory Clinical Study of MT-2301

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Haemophilus Influenza Type b

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MT-2301-Low

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

0.25mL, subcutaneous injection

MT-2301-High

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

0.5mL, subcutaneous injection

ActHIB

Group Type ACTIVE_COMPARATOR

Haemophilus influenza type b conjugate vaccine + DPT-IPV

Intervention Type BIOLOGICAL

0.5mL, subcutaneous injection

Interventions

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

0.25mL, subcutaneous injection

Intervention Type BIOLOGICAL

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

0.5mL, subcutaneous injection

Intervention Type BIOLOGICAL

Haemophilus influenza type b conjugate vaccine + DPT-IPV

0.5mL, subcutaneous injection

Intervention Type BIOLOGICAL

Other Intervention Names

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MT-2301-Low + Tetrabik® MT-2301-High + Tetrabik® ActHIB® + Tetrabik®

Eligibility Criteria

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Inclusion Criteria

* Healthy infants aged ≥2 and \<7 months at the first vaccination of the study drug
* Written informed consent is obtained from a legal guardian (parent)

Exclusion Criteria

* With obvious pyrexia (axillary temperature of 37.5ºC or higher) at vaccination of the study drug
* With known serious acute disease
* With known underlying disease such as cardiovascular disease, renal disease, hepatic disease, blood dyscrasia, and respiratory disease
* With past diagnosis of immunodeficiency or currently under immunosuppressive treatment
* History of anaphylaxis due to food or pharmaceuticals
* With experience of Hib infection, diphtheria, pertussis, tetanus, and acute poliomyelitis
* With experience of Hib vaccination, or administration of vaccine including either diphtheria, pertussis, tetanus, or polio as a constituent
* History of convulsions
* Administered a live vaccine within 27 days before the first vaccination of the study drug, or inactivated vaccine or toxoid within 6 days before vaccination
* Administered transfusion, immunosuppressant (excluding drugs for external use), or immunoglobulin formulation
* Administered corticosteroid 2 mg/kg per day or more as prednisolone (excluding drugs for external use) continuously for more than 1 week
* Participated in other studies within 12 weeks before obtaining consent

Minimum Eligible Age

2 Months

Maximum Eligible Age

7 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes