Exploratory Clinical Study of MT-2301

NCT02140047 | Completed Phase 2 Results DMC

• 1 other identifier: MT-2301-J01
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Haemophilus Influenza Type b

Keywords

Haemophilus influenza type b; Hib

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• 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 primary immunization (Visit 4)

• Geometric Mean Antibody Titer of Anti-PRP Antibody

  4 weeks after the primary immunization (Visit 4)

• 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)

• 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)

Study Arms (3)

MT-2301-Low

EXPERIMENTAL

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

MT-2301-High

EXPERIMENTAL

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

ActHIB

ACTIVE COMPARATOR

Biological: Haemophilus influenza type b conjugate vaccine + DPT-IPV

Interventions

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

0.25mL, subcutaneous injection

Also known as: MT-2301-Low + Tetrabik®

MT-2301-Low

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

0.5mL, subcutaneous injection

Also known as: MT-2301-High + Tetrabik®

MT-2301-High

Haemophilus influenza type b conjugate vaccine + DPT-IPV BIOLOGICAL

0.5mL, subcutaneous injection

Also known as: ActHIB® + Tetrabik®

ActHIB

Eligibility Criteria

• Age: 2 Months - 7 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (1)

Investigational site

Fukuoka, Fukuoka, Japan

Location

MeSH Terms

Conditions

Haemophilus Infections

Interventions

Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate

Condition Hierarchy (Ancestors)

Pasteurellaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Clinical Trials, Information Desk
• Organization: Tanabe Pharma Corporation

cti-inq-ml.JP@ml.tanabe-pharma.com

+81-120-753-280

Study Officials

• Takashi Nakano, M.D., Ph.D.

  Department of pediatrics, Kawasaki Hospital, Kawasaki Medical School

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2014
• First Posted: May 16, 2014
• Study Start: April 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: September 1, 2015
• Last Updated: March 17, 2026
• Results First Posted: September 19, 2024

Record last verified: 2026-03

Locations

JP (1)