Study of BK1803 in Healthy Infants

NCT07793513 | Not Yet Recruiting Phase 3

• 2 other identifiers: BK1803-A-301jRCT2031260370
• Study Type: interventional
• Target: 344
• Locations: 1 country
• Sites: 33

Brief Summary

This study is a phase 3, randomized, observer-blinded, active-controlled, multicenter study to evaluate the immunogenicity and safety of BK1803 in healthy infants aged 2 months to less than 7 months. Participants will be randomized to receive either BK1803 or a control regimen consisting of GOBIK Aqueous Suspension Syringes and Bimmugen® Injection. The primary objective is to demonstrate the noninferiority of BK1803 compared with the control in terms of antibody seroprotection rates against hepatitis B surface (HBs) antigen, Haemophilus influenzae type b (Hib), pertussis, diphtheria, tetanus, and poliovirus. Safety will also be assessed throughout the study.

Conditions

Pertussis; Diphtheria; Tetanus; Poliomyelitis; Hepatitis B; Haemophilus Influenzae Type b

Keywords

Hepatitis B; Haemophilus influenzae type b; Pertussis; Diphtheria; Tetanus; Poliomyelitis; Combination Vaccine; BK1803; Infants

Outcome Measures

Primary Outcomes (3)

• Antibody seroprotection rates against vaccine antigens in the BK1803 of Main Cohort

  The antibody seroprotection rates against hepatitis B surface (HBs) antigen, polyribosylribitol phosphate (PRP), Bordetella pertussis (pertussis toxin \[PT\] and filamentous hemagglutinin \[FHA\]), diphtheria toxin, tetanus toxin, and attenuated poliovirus will be evaluated.

  4 weeks from the post-primary immunization of BK1803 in Main Cohort (Visit4)

• Antibody seroprotection rates against vaccine antigens for HBs antigen in the Control of Main Cohort

  The antibody seroprotection rates against hepatitis B surface (HBs) antigen will be evaluated.

  4 weeks from the post-booster immunization of Bimmugen in Main Cohort (Visit6)

• The antibody seroprotection rates against vaccine antigens for PRP, PT and FHA, diphtheria toxin, tetanus toxin, and attenuated poliovirus in the Control of Main Cohort

  The antibody seroprotection rates against polyribosylribitol phosphate (PRP), Bordetella pertussis (pertussis toxin \[PT\] and filamentous hemagglutinin \[FHA\]), diphtheria toxin, tetanus toxin, and attenuated poliovirus will be evaluated.

  4 weeks from the post-primary immunization of GOBIK in Main Cohort (Visit4)

Secondary Outcomes (7)

• Geometric mean antibody titers for HBs antigen

  4 weeks from the post-primary immunization and the post-booster immunization in Safety Lead-in Cohort (Visit 4 and 8); 4 weeks from the post-primary immunization of BK1803 and the post-booster immunization of BK1803/Bimmugen in Main Cohort (Visit 4,6,8)

• Geometric mean antibody titers for PRP

  4 weeks from the post-primary immunization and the post-booster immunization in Safety Lead-in Cohort (Visit 4 and 8); 4 weeks from the post-primary immunization and the post-booster immunization of BK1803/GOBIK in Main Cohort (Visit 4 and 8)

• Geometric mean antibody titers for Bordetella pertussis (PT and FHA)

  4 weeks from the post-primary immunization and the post-booster immunization in Safety Lead-in Cohort (Visit 4 and 8); 4 weeks from the post-primary immunization and the post-booster immunization of BK1803/GOBIK in Main Cohort (Visit 4 and 8)

• Geometric mean antibody titers for diphtheria toxin

  4 weeks from the post-primary immunization and the post-booster immunization in Safety Lead-in Cohort (Visit 4 and 8); 4 weeks from the post-primary immunization and the post-booster immunization of BK1803/GOBIK in Main Cohort (Visit 4 and 8)

• Geometric mean antibody titers for tetanus toxin

  4 weeks from the post-primary immunization and the post-booster immunization in Safety Lead-in Cohort (Visit 4 and 8); 4 weeks from the post-primary immunization and the post-booster immunization of BK1803/GOBIK in Main Cohort (Visit 4 and 8)

Study Arms (3)

Safety Lead-in Cohort: BK1803

EXPERIMENTAL

Subjects receive BK1803 administered according to the study vaccination schedule, including primary and booster immunizations.

Biological: BK1803

Main Cohort: BK1803

EXPERIMENTAL

Subjects receive BK1803 administered according to the study vaccination schedule, including primary and booster immunizations.

Biological: BK1803

Main Cohort: Control (GOBIK and Bimmugen)

ACTIVE COMPARATOR

Subjects receive control vaccines consisting of GOBIK Aqueous Suspension Syringes and Bimmugen® Injection according to the study vaccination schedule, including primary and booster immunizations.

Biological: GOBIK Aqueous Suspension Syringes; Biological: Bimmugen® Injection

Interventions

BK1803 BIOLOGICAL

BK1803 is a combination vaccine administered intramuscularly according to the study vaccination schedule, including primary and booster immunizations.

Main Cohort: BK1803; Safety Lead-in Cohort: BK1803

GOBIK Aqueous Suspension Syringes BIOLOGICAL

GOBIK Aqueous Suspension Syringes is a combination vaccine administered intramuscularly according to the study vaccination schedule.

Main Cohort: Control (GOBIK and Bimmugen)

Bimmugen® Injection BIOLOGICAL

Bimmugen® Injection is a hepatitis B vaccine administered subcutaneously according to the study vaccination schedule.

Main Cohort: Control (GOBIK and Bimmugen)

Eligibility Criteria

• Age: 2 Months - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Japanese healthy infants aged \>= 2 months and \< 7 months at the time of the first vaccination with the study drug. However, although subjects meeting the following definition of "subjects who should receive a vaccination with care" may participate in the study, whether or not to enroll them in the study should be decided carefully by the (sub)investigator.
• Subjects from whose legal guardians (persons with parental rights) written consent to study participation has been obtained.
• Subjects Who Should Receive A Vaccination With Care 4) applies only to the Main Cohort.
• Subjects who clearly have underlying diseases, such as cardiovascular disease, kidney disease, liver disease, blood disease, respiratory disease, or a developmental disorder
• Subjects who have developed a pyrexia within 2 days after receiving a vaccination in the past
• Subjects with a past history of convulsions
• (Main Cohort only) Subjects with the gestational age \<37 weeks, or who weighed less than 2500 g at birth

You may not qualify if:

• Subjects who have received diagnoses of immunodeficiencies in the past, or who are currently receiving treatments that cause immunosuppression
• Subjects with close relatives (up to third degree of kinship) who have a congenital immunodeficiency
• Subjects who might experience a serious allergy in response to a food, drug product (especially any component of the study drug), etc.
• Subjects who have had Haemophilus Influenzae type b (Hib) infections, pertussis, diphtheria, tetanus, acute poliomyelitis, or hepatitis B in the past
• Subjects who have received a vaccination against Hib, pertussis, diphtheria, tetanus, polio, or hepatitis B in the past
• Subjects who have received hepatitis B immunoglobulin (HBIG) for the prevention of vertical infection in the past
• Subjects who were born to a mother who had received a vaccination against Hib, pertussis, diphtheria, tetanus, polio, or hepatitis B (including a combination vaccine such as diphtheria-pertussis-tetanus vaccine) during pregnancy
• Subjects who are receiving anticoagulant therapy or who have thrombocytopenia or coagulation disorder
• Subjects with fibrodysplasia ossificans progressiva
• Subjects who have received live vaccines within 27 days before the first vaccination with the study drug
• Subjects who have received inactivated vaccines/toxoids or mRNA vaccines within 6 days before the first vaccination with the study drug
• Subjects who have received blood transfusions, immunosuppressants (except for topical drugs), or immunoglobulin preparations in the past
• Subjects who have received corticosteroids (except for topical drugs) at a prednisolone dose level equivalent of 2 mg/kg/day or higher in the past
• Subjects who have participated in another clinical study and received another study drug within 12 weeks before obtaining informed consent
• (Safety Lead-in Cohort only) Subjects with the gestational age \<37 weeks, or who weighed less than 2500 g at birth

Sponsors & Collaborators

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

Study Sites (33)

Fukui Aiiku Hospital

Fukui-shi, Fukui, 910-0833, Japan

Location

Oda Children's Allergy Clinic

Fukuoka, Fukuoka, 810-0022, Japan

Location

Morooka Chirdren's Chikushi-dori Clinic

Fukuoka, Fukuoka, 812-0894, Japan

Location

Shindo children's clinic

Fukuoka, Fukuoka, 814-0121, Japan

Location

Kurokawa Michiko Pediatric Clinic

Fukuoka, Fukuoka, 815-0033, Japan

Location

Japanese Red Cross Fukuoka Hospital

Fukuoka, Fukuoka, 815-8555, Japan

Location

Isesaki Municipal Hospital

Isesaki, Gunma, 372-0817, Japan

Location

Japanese Red Cross Maebashi Hospital

Maebashi, Gunma, 371-0811, Japan

Location

Yoshimitsu Pediatric Clinic

Hiroshima, Hiroshima, 731-0124, Japan

Location

Taniguchi Children Clinic

Hiroshima, Hiroshima, 732-0023, Japan

Location

Ishikari Kids Clinic

Ishikari-shi, Hokkaido, 061-3202, Japan

Location

Hibarigaoka Kodomo Clinic

Sapporo, Hokkaido, 004-0052, Japan

Location

Araki Children Clinic

Sapporo, Hokkaido, 006-0814, Japan

Location

Japan Community Healthcare Organization Hokkaido Hospital

Sapporo, Hokkaido, 062-8618, Japan

Location

Kumagai Children's Clinic

Amagasaki, Hyōgo, 661-0953, Japan

Location

Hamami Kodomo Clinic

Chigasaki, Kanagawa, 253-0062, Japan

Location

Kawasaki Municipal Hospital

Kawasaki-shi, Kanagawa, 210-0013, Japan

Location

Sagamihara Kyodo Hospital

Sagamihara, Kanagawa, 252-5188, Japan

Location

Kochi Health Sciences Center

Kochi, Kochi, 781-8555, Japan

Location

Sakuranbo Kodomo Clinic

Kumamoto, Kumamoto, 862-0924, Japan

Location

Ina Central Hospital

Ina-shi, Nagano, 396-8555, Japan

Location

JISENKAI Healthcare Incorporated Foundation, Aizawa Hospital

Matsumoto, Nagano, 390-8510, Japan

Location

Arakawa Family Clinic

Nagano, Nagano, 381-0025, Japan

Location

Asama General Hospital

Saku, Nagano, 385-8558, Japan

Location

Nara Prefecture General Medical Center

Nara, Nara, 630-8581, Japan

Location

Aizenbashi Hospital

Osaka, Osaka, 556-0005, Japan

Location

Aiwa Hospital

Kawagoe-shi, Saitama, 350-0001, Japan

Location

Hara Children's Clinic

Tokorozawa, Saitama, 359-1141, Japan

Location

Yaizu City Hospital

Yaizu, Shizuoka, 425-8505, Japan

Location

Medical Corporation Asbo Tokyo Asbo Clinic

Chuo-ku, Tokyo, 104-0031, Japan

Location

Aquakids Clinic

Edogawa-Ku, Tokyo, 133-0056, Japan

Location

Okawa Children & Family Clinic

Ōta-ku, Tokyo, 146-0095, Japan

Location

Karugamo Clinic

Setagaya-Ku, Tokyo, 156-0054, Japan

Location

MeSH Terms

Conditions

Whooping Cough; Diphtheria; Tetanus; Poliomyelitis; Hepatitis B; Haemophilus Infections

Condition Hierarchy (Ancestors)

Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Clostridium Infections; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Pasteurellaceae Infections

Study Officials

• General Manager

  Tanabe Pharma Corporation

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Information Desk

CONTACT

Please email; cti-inq-ml.JP@ml.tanabe-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is an observer-blinded study in which outcome assessors are blinded to treatment assignment. Due to differences in administration methods and study procedures, participants and care providers are not blinded. Measures are taken to maintain blinding of outcome assessors, including separation of personnel involved in vaccination and those involved in outcome evaluation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants are randomized in a 1:1 ratio to receive either BK1803 or a control regimen consisting of GOBIK Aqueous Suspension Syringes and Bimmugen® Injection.

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

JP (33)