PertussisPhase 3NCT07793513

Study of BK1803 in Healthy Infants

A Phase 3 study testing BK1803, GOBIK Aqueous Suspension Syringes and Bimmugen® Injection in people with Pertussis and Diphtheria, run by Tanabe Pharma Corporation at 33 sites in Japan.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 2 to 6 monthsHealthy volunteers can take part
Conditions the study is for: Pertussis, Diphtheria, Tetanus
What is being tested?: BK1803, GOBIK Aqueous Suspension Syringes and Bimmugen® Injection
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 344 participants
Where: 33 sitesJapan
Study dates: Oct 2026to Apr 2029
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 6 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Subjects meeting all of the following inclusion criteria at the time of the first vaccination with the study drug will be eligible for study participation.
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

Who cannot join

Subjects meeting any of the following exclusion criteria at the time of the first vaccination with the study drug will be excluded from study participation. However, (15) applies only to the Safety Lead-in Cohort.
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

Show all 17Show fewer

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
Subjects otherwise judged to be unsuitable for participation in this study by the (sub)investigator

Trial locations and contacts

33 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Information Desk contact

Please email

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

City, postcode or hospital

33 sites in 1 country

Japan33 sites

Kumagai Children's Clinic
Amagasaki, Hyōgo, 661-0953
Hamami Kodomo Clinic
Chigasaki, Kanagawa, 253-0062
Medical Corporation Asbo Tokyo Asbo Clinic
Chuo-ku, Tokyo, 104-0031
Aquakids Clinic
Edogawa-Ku, Tokyo, 133-0056
Fukui Aiiku Hospital
Fukui-shi, Fukui, 910-0833
Oda Children's Allergy Clinic
Fukuoka, Fukuoka, 810-0022
Morooka Chirdren's Chikushi-dori Clinic
Fukuoka, Fukuoka, 812-0894
Shindo children's clinic
Fukuoka, Fukuoka, 814-0121
Kurokawa Michiko Pediatric Clinic
Fukuoka, Fukuoka, 815-0033
Japanese Red Cross Fukuoka Hospital
Fukuoka, Fukuoka, 815-8555
Yoshimitsu Pediatric Clinic
Hiroshima, Hiroshima, 731-0124
Taniguchi Children Clinic
Hiroshima, Hiroshima, 732-0023
Ina Central Hospital
Ina-shi, Nagano, 396-8555
Isesaki Municipal Hospital
Isesaki, Gunma, 372-0817
Ishikari Kids Clinic
Ishikari-shi, Hokkaido, 061-3202
Aiwa Hospital
Kawagoe-shi, Saitama, 350-0001
Kawasaki Municipal Hospital
Kawasaki-shi, Kanagawa, 210-0013
Kochi Health Sciences Center
Kochi, Kochi, 781-8555
Sakuranbo Kodomo Clinic
Kumamoto, Kumamoto, 862-0924
Japanese Red Cross Maebashi Hospital
Maebashi, Gunma, 371-0811
JISENKAI Healthcare Incorporated Foundation, Aizawa Hospital
Matsumoto, Nagano, 390-8510
Arakawa Family Clinic
Nagano, Nagano, 381-0025
Nara Prefecture General Medical Center
Nara, Nara, 630-8581
Aizenbashi Hospital
Osaka, Osaka, 556-0005
Okawa Children & Family Clinic
Ōta-ku, Tokyo, 146-0095
Sagamihara Kyodo Hospital
Sagamihara, Kanagawa, 252-5188
Asama General Hospital
Saku, Nagano, 385-8558
Hibarigaoka Kodomo Clinic
Sapporo, Hokkaido, 004-0052
Araki Children Clinic
Sapporo, Hokkaido, 006-0814
Japan Community Healthcare Organization Hokkaido Hospital
Sapporo, Hokkaido, 062-8618
Karugamo Clinic
Setagaya-Ku, Tokyo, 156-0054
Hara Children's Clinic
Tokorozawa, Saitama, 359-1141
Yaizu City Hospital
Yaizu, Shizuoka, 425-8505

Other trials in Japan

About this study

Official title: Confirmatory Study of BK1803 in Healthy Infants (Comparative Study Using GOBIK Aqueous Suspension Syringes and Bimmugen® Injection as a Control)

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.

Read the detailed description

This is a phase 3, randomized, observer-blinded, active-controlled, parallel-group, multicenter study to evaluate the immunogenicity and safety of BK1803 in healthy infants.

BK1803 is a combined vaccine containing antigens against diphtheria, pertussis, tetanus, inactivated poliovirus, Haemophilus influenzae type b (Hib), and hepatitis B. This study aims to assess whether BK1803 provides immunogenicity comparable to standard vaccination regimens.

The study consists of two cohorts: a safety lead-in cohort and a main cohort. In the safety lead-in cohort, participants receive BK1803 to evaluate its initial safety and tolerability before initiating the main cohort. In the main cohort, 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.

Participants will receive primary and booster immunizations according to the study schedule, and immunogenicity will be evaluated based on antibody responses to multiple vaccine antigens. Safety will be monitored throughout the study period.

Conditions: Pertussis, Diphtheria, Tetanus, Poliomyelitis, Hepatitis B, Haemophilus Influenzae Type b
Being tested: BK1803, GOBIK Aqueous Suspension Syringes, Bimmugen® Injection
Keywords: Hepatitis B, Haemophilus influenzae type b, Pertussis, Diphtheria, Tetanus, Poliomyelitis, Combination Vaccine, BK1803, Infants
Medical subject headings: Whooping Cough, Diphtheria, Tetanus, Poliomyelitis, Hepatitis B, Haemophilus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BK1803Biological
BK1803 is a combination vaccine administered intramuscularly according to the study vaccination schedule, including primary and booster immunizations.
GOBIK Aqueous Suspension SyringesBiological
GOBIK Aqueous Suspension Syringes is a combination vaccine administered intramuscularly according to the study vaccination schedule.
Bimmugen® InjectionBiological
Bimmugen® Injection is a hepatitis B vaccine administered subcutaneously according to the study vaccination schedule.

Study groups in NCT07793513
Study group	Role	What they receive
Safety Lead-in Cohort: BK1803	Experimental	Subjects receive BK1803 administered according to the study vaccination schedule, including primary and booster immunizations. Receives: Biological: BK1803
Main Cohort: BK1803	Experimental	Subjects receive BK1803 administered according to the study vaccination schedule, including primary and booster immunizations. Receives: 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. Receives: Biological: GOBIK Aqueous Suspension Syringes; Biological: Bimmugen® Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (7)

Geometric mean antibody titers for HBs antigen
Geometric mean antibody titers against hepatitis B surface (HBs) antigen will be evaluated.
Measured: 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
Geometric mean antibody titers against PRP will be evaluated.
Measured: 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)
Geometric mean antibody titers against Bordetella pertussis (PT and FHA) will be evaluated.
Measured: 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
Geometric mean antibody titers against diphtheria toxin will be evaluated.
Measured: 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
Geometric mean antibody titers against tetanus toxin will be evaluated.
Measured: 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 attenuated poliovirus
Geometric mean antibody titers against attenuated poliovirus will be evaluated.
Measured: 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)
Antibody seroprotection rates against vaccine antigens
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.
Measured: 4 weeks from the post-primary and the post-booster of BK1803 in Safety Lead-in Cohort (visit 4and 8); 4 weeks from the post-booster of BK1803/GOBIK in Main Cohort (visit 8)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2026Apr 2029

First posted28 Aug 2026
Study startOct 2026 (estimated)
Primary completionApr 2029 (estimated)
Study completionApr 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PertussisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 344 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07793513
Sponsor's protocol ID: BK1803-A-301
Other IDs: jRCT2031260370
Status last verified: Aug 2026
First submitted: 17 Aug 2026
Last updated: 28 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No