Confirmatory Study of BK1310 in Healthy Infants

Phase 3 Study of BK1310 Compared With ActHIB® and Tetrabik in Healthy Infants: A Randomized, Assessor-blind, Active-controlled

The purpose of this study is to evaluate immunogenicity of BK1310 for all antigens (anti-PRP, diphtheria toxin, pertussis, tetanus toxin, and polio virus), after 3 times of injection, when compared noninferiority with co-administration of ActHIB® and Tetrabik, as well as efficacy and safety, in healthy infants.

Study Overview

• Status: Completed
• Conditions: Pertussis; Tetanus; Diphtheria; Bacterial Meningitis; Poliomyelitis
• Intervention / Treatment: Biological: DPT-IPV-Hib; Biological: Hib vaccine; Biological: DPT-IPV

• Study Type: Interventional
• Enrollment (Actual): 267
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 3 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy infants aged ≥2 and <43 months at the first vaccination of the study drug (recommended: ≥2 and <7 months)
• Written informed consent is obtained from a legal guardian (parent)

Exclusion Criteria:

• 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.
• Participated in other studies within 12 weeks before obtaining consent
• Considered to be not eligible by the principal investigators (sub-investigators) of the enrollment

Additional screening criteria check may apply for qualification.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: BK1310	Biological: DPT-IPV-Hib; 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.; Other Names: BK1310
ACTIVE_COMPARATOR: ActHIB® and Tetrabik	Biological: Hib vaccine; 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.; Other Names: ActHIB®; Biological: DPT-IPV; 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.; Other Names: Tetrabik

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Antibody prevalence rate against anti-PRP with 1 μg/mL or higher, diphtheria toxin, pertussis, tetanus toxin, and polio virus	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	4weeks after the primary immunization (Visit 4)
Geometric mean antibody titer of anti-PRP antibody	4weeks after the primary immunization (Visit 4)
Anti-PRP antibody prevalence rate with 1 μg/mL or higher	4weeks after the booster dose (Visit 6)
Geometric mean antibody titer of anti-PRP antibody	4weeks after the booster dose (Visit 6)
Geometric mean antibody titer against diphtheria toxin, pertussis, tetanus toxin, and polio virus	4weeks after the primary immunization (Visit 4)
Antibody prevalence rate against diphtheria toxin, pertussis, tetanus toxin, and polio virus	4weeks after the booster dose (Visit 6)
Geometric mean antibody titer against diphtheria toxin, pertussis, tetanus toxin, and polio virus	4weeks after the booster dose (Visit 6)
Adverse events and adverse reactions	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Mitsubishi Tanabe Pharma Corporation
• Collaborators: The Research Foundation for Microbial Diseases of Osaka University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2019
• Primary Completion (ACTUAL): September 18, 2019
• Study Completion (ACTUAL): August 10, 2020

Study Registration Dates

• First Submitted: March 24, 2019
• First Submitted That Met QC Criteria: March 26, 2019
• First Posted (ACTUAL): March 27, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 13, 2020
• Last Update Submitted That Met QC Criteria: November 11, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Hib; Haemophilus influenza type b; DPT-IPV; Adsorbed Diphtheria-purified Pertussis-Tetanus- Inactivate poliovirus combined vaccine
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Neuromuscular Diseases; Central Nervous System Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Enterovirus Infections; Picornaviridae Infections; Spinal Cord Diseases; Clostridium Infections; Corynebacterium Infections; Central Nervous System Bacterial Infections; Myelitis; Whooping Cough; Tetanus; Diphtheria; Meningitis; Poliomyelitis; Meningitis, Bacterial
• Other Study ID Numbers: BK1310-J03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No