Exploratory Clinical Study of MT-2301

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

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.

Study Overview

• Status: Completed
• Conditions: Haemophilus Influenza Type b
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 157
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan
      • Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 7 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	Time Frame
Anti-PRP antibody prevalence rate with 0.15 μg/mL or higher	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 primary immunization (Visit 4)
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)

Collaborators and Investigators

• Sponsor: Mitsubishi Tanabe Pharma Corporation
• Investigators: Study Director: Takashi Nakano, M.D., Ph.D., Department of pediatrics, Kawasaki Hospital, Kawasaki Medical School

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: May 14, 2014
• First Submitted That Met QC Criteria: May 14, 2014
• First Posted (Estimate): May 16, 2014

Study Record Updates

• Last Update Posted (Estimate): October 19, 2015
• Last Update Submitted That Met QC Criteria: October 15, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Hib; Haemophilus influenza type b
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: MT-2301-J01