Phase 3 Study of BK1310 in Healthy Infants

NCT02992925 | Completed Phase 3 Results

• 1 other identifier: BK1310-J01
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to:

• (cohort 1) evaluate safety and immunogenicity (Haemophilus influenzae type b, Hib) of BK1310.
• (cohort 2) evaluate efficacy and safety of BK1310 using ActHIB® and Tetrabik as a control in healthy infants.

Conditions

Immunization; Infection

Keywords

Haemophilus influenza type b; Adsorbed Diphteria-purified Pertussis-Tetanus-Inactivate poliovirus combined vaccine; Hib; DPT-IPV

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 (4)

Cohort 1: BK1310-High

EXPERIMENTAL

Biological: DPT-IPV-Hib-High（Combined Vaccine）

Cohort 1: BK1310-Low

EXPERIMENTAL

Biological: DPT-IPV-Hib-Low（Combined Vaccine）

Cohort 2: BK1310-High or -Low

EXPERIMENTAL

Either BK1310-High or -Low will be chosen based on the result of cohort 1

Biological: DPT-IPV-Hib-High（Combined Vaccine）; Biological: DPT-IPV-Hib-Low（Combined Vaccine）

Cohort 2: ActHIB® and Tetrabik

ACTIVE COMPARATOR

Biological: Hib vaccine; Biological: DPT-IPV

Interventions

DPT-IPV-Hib-High（Combined Vaccine） BIOLOGICAL

Also known as: BK1310-High

Cohort 1: BK1310-High; Cohort 2: BK1310-High or -Low

DPT-IPV-Hib-Low（Combined Vaccine） BIOLOGICAL

Also known as: BK1310-Low

Cohort 1: BK1310-Low; Cohort 2: BK1310-High or -Low

Hib vaccine BIOLOGICAL

Also known as: ActHIB®

Cohort 2: ActHIB® and Tetrabik

DPT-IPV BIOLOGICAL

Also known as: Tetrabik

Cohort 2: ActHIB® and Tetrabik

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 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)

Unknown Facility

Fukuoka, Fukuoka, Japan

Location

Unknown Facility

Kasuga-shi, Fukuoka, Japan

Location

Unknown Facility

Sendai, Miyagi, Japan

Location

MeSH Terms

Conditions

Infections; Haemophilus Infections

Interventions

HibTITER protein, Haemophilus influenzae; Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate

Condition Hierarchy (Ancestors)

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

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: 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: December 1, 2016
• First Posted: December 14, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: November 1, 2018
• Last Updated: January 6, 2026
• Results First Posted: January 7, 2025

Record last verified: 2025-12

Locations

JP (3)