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Exploratory Clinical Study of MT-2301

Phase 2
Completed
Conditions
Haemophilus Influenza Type b
Interventions
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
Registration Number
NCT02140047
Lead Sponsor
Mitsubishi Tanabe Pharma Corporation
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
157
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)
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
MT-2301-LowHaemophilus b conjugate vaccine diphteria CRM197 protein conjugate)-Low + DPT-IPV-
MT-2301-HighHaemophilus b conjugate vaccine diphteria CRM197 protein conjugate)-High + DPT-IPV-
ActHIBHaemophilus influenza type b conjugate vaccine + DPT-IPV-
Primary Outcome Measures
NameTimeMethod
Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Antibody Against Anti-PRP4 weeks after the primary immunization (Visit 4)
Secondary Outcome Measures
NameTimeMethod
Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody4 weeks after the booster dose (Visit 6)
Geometric Mean Antibody Titer of Anti-PRP Antibody4 weeks after the booster dose (Visit 6)
Anti-PRP Antibody Prevalence Rate With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody4 weeks after the booster dose (Visit 6)
Geometric Mean Antibody Titer Against Diphtheria Toxin4 weeks after the booster dose (Visit 6)
Geometric Mean Antibody Titer Against Pertussis4 weeks after the booster dose (Visit 6)
Geometric Mean Antibody Titer Against Tetanus Toxin4 weeks after the booster dose (Visit 6)
Fold Change in Geometric Mean Antibody Titer Against Polio Virus4 weeks after the booster dose (Visit 6)

Trial Locations

Locations (1)

Investigational site

🇯🇵

Fukuoka-shi, Fukuoka, Japan

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