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-IPVBiological: Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate)-High + DPT-IPVBiological: 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
Group Intervention Description MT-2301-Low Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate)-Low + DPT-IPV - MT-2301-High Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate)-High + DPT-IPV - ActHIB Haemophilus influenza type b conjugate vaccine + DPT-IPV -
- Primary Outcome Measures
Name Time Method Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Antibody Against Anti-PRP 4 weeks after the primary immunization (Visit 4)
- Secondary Outcome Measures
Name Time Method Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody 4 weeks after the booster dose (Visit 6) Geometric Mean Antibody Titer of Anti-PRP Antibody 4 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 Antibody 4 weeks after the booster dose (Visit 6) Geometric Mean Antibody Titer Against Diphtheria Toxin 4 weeks after the booster dose (Visit 6) Geometric Mean Antibody Titer Against Pertussis 4 weeks after the booster dose (Visit 6) Geometric Mean Antibody Titer Against Tetanus Toxin 4 weeks after the booster dose (Visit 6) Fold Change in Geometric Mean Antibody Titer Against Polio Virus 4 weeks after the booster dose (Visit 6)
Trial Locations
- Locations (1)
Investigational site
🇯🇵Fukuoka-shi, Fukuoka, Japan