Exploratory Clinical Study of MT-2301

Study Overview
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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.

Official Title
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Exploratory Clinical Study of MT-2301 in Healthy Infants (Phase 2)

Conditions
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Haemophilus Influenza Type b

Intervention / Treatment
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* Biological: Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate)-Low + DPT-IPV
* Biological: Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate)-High + DPT-IPV
* Biological: Haemophilus influenza type b conjugate vaccine + DPT-IPV


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 7 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MT-2301-Low<br> | Biological: Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate)-Low + DPT-IPV<br>* 0.25mL, subcutaneous injection<br>* Other names: MT-2301-Low + Tetrabik®;|
| Experimental: MT-2301-High<br> | Biological: Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate)-High + DPT-IPV<br>* 0.5mL, subcutaneous injection<br>* Other names: MT-2301-High + Tetrabik®;|
| Active Comparator: ActHib<br> | Biological: Haemophilus influenza type b conjugate vaccine + DPT-IPV<br>* 0.5mL, subcutaneous injection<br>* Other names: ActHib® + Tetrabik®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-PRP antibody prevalence rate with 1 μg/mL or higher |  | 4 weeks after the primary immunization (Visit 4) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-PRP antibody prevalence rate with 0.15 μg/mL or higher |  | 4 weeks after the primary immunization (Visit 4) | 
| Geometric mean antibody titer (GMT) of anti-PRP antibody |  | 4 weeks after the primary immunization (Visit 4) | 
| Anti-PRP antibody prevalence rate with 1 μg/mL or higher |  | 4 weeks after the booster dose (Visit 6) | 
| Anti-PRP antibody prevalence rate with 0.15 μg/mL or higher |  | 4 weeks after the booster dose (Visit 6) | 
| Geometric mean antibody titer (GMT) of anti-PRP antibody |  | 4 weeks after the booster dose (Visit 6) | 
| Antibody prevalence rate and geometric mean antibody titer (GMT) against diphtheria toxin, pertussis, tetanus toxin, and less virulent strain of polio virus |  | 4 weeks after the primary immunization (Visit 4) | 
| Antibody prevalence rate and geometric mean antibody titer (GMT) against diphtheria toxin, pertussis, tetanus toxin, and less virulent strain of polio virus |  | 4 weeks after the booster dose (Visit 6) | 
| Adverse events and adverse reactions |  | through the first dose (Visit 1) to 4 weeks after the booster dose (Visit 6) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hib, Haemophilus influenza type b