Safety and Efficacy of BK1310 Intramuscular Injection in Healthy Infants

NCT03188692 | Completed Phase 3 Results

• 1 other identifier: BK1310-J02
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of an intramuscular injection of BK1310 in healthy infants.

Conditions

Immunization

Keywords

Haemophilus influenza type b; Adsorbed Diphtheria-Purified Pertussis-Tetanus-Inactivate; poliovirus combined vaccine; Hib; DPT-IPV; Intramuscular

Outcome Measures

Primary Outcomes (1)

• Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP

  Antibody prevalence rate is defined as the percentage of participants whose criteria of each antibody titer: Anti-diphtheria antibody concentrations: \>=0.1 IU/mL, Anti-PT antibody concentrations: \>=10.0 EU/mL, Anti-FHA antibody concentrations: \>=10.0 EU/mL, Anti-tetanus antibody concentrations: \>=0.01 IU/mL, Anti-poliovirus serotype 1,2 and 3 antibody titers (fold) \>=8

  4 weeks after the primary immunization (Visit 4)

Secondary Outcomes (16)

• 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 (1)

BK1310

EXPERIMENTAL

Biological: DPT-IPV-Hib (Combined Vaccine)

Interventions

DPT-IPV-Hib (Combined Vaccine) BIOLOGICAL

0.5mL, intramuscular injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.

Also known as: BK1310

BK1310

Eligibility Criteria

• Age: 2 Months - 43 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy infants aged ≥2 and \<43 months at the first vaccination of the study drug (recommended: ≥2 and \<7 months). Those who are applicable of the following conditions must be carefully observed before the enrollment: infants with known underlying disease such as cardiovascular disease, renal disease, hepatic disease, blood dyscrasia, respiratory disease or developmental disorder. Infants who developed fever within 2 days after any previous vaccination. Infants with history of convulsions.
• Written informed consent is obtained from a legal guardian (parent)

You may not qualify if:

• With past diagnosis of immunodeficiency or currently under immunosuppressive treatment
• Have close relatives (the third degree of kinship) diagnosed with congenital immunodeficiency
• Possibility of anaphylaxis due to food or pharmaceuticals
• With diagnosis of thrombocytopenia and/or coagulopathy or currently under treatment of the antiplatelet agents and/or anticoagulant agents.
• With experience of Hib infection, diphtheria, pertussis, tetanus or acute poliomyelitis
• With experience of Hib, diphteria, pertussis, tetanus or polio vaccination.
• 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)
• Participated in other studies within 12 weeks before obtaining consent
• With the gestational age \<37 weeks or weighed less than 2500 grams at birth.
• Considered to be not eligible by the principal investigators (sub-investigators) of the enrollment.

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead
• The Research Foundation for Microbial Diseases of Osaka University: collaborator

Study Sites (3)

Investigational site 1

Chiba, Japan

Location

Investigational site 2

Tokyo, Japan

Location

Investigational site 3

Tokyo, Japan

Location

MeSH Terms

Conditions

Haemophilus Infections

Interventions

Vaccines, Combined

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Clinical Trials, Information Desk
• Organization: Tanabe Pharma Corporation / The Research Foundation for Microbial Diseases of Osaka University

cti-inq-ml.JP@ml.tanabe-pharma.com, clinicaldevelopment@mail.biken.or.jp

Please email

Study Officials

• General Manager

  Tanabe Pharma Corporation

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 15, 2017
• Study Start: June 23, 2017
• Primary Completion: November 2, 2017
• Study Completion: August 9, 2018
• Last Updated: January 6, 2026
• Results First Posted: January 3, 2025

Record last verified: 2025-12

Locations

JP (3)