A Phase 3 interventional study of BK1803 and GOBIK Aqueous Suspension Syringes in Pertussis, Diphtheria and Tetanus, sponsored by Tanabe Pharma Corporation. Not yet recruiting at 33 sites in Japan. Open to participants aged 2 Months to 6 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Tanabe Pharma Corporation · Phase 3, Interventional, and Prevention
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.
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.
290 studies on the registry are indexed under Whooping Cough; 23 are open to participants now.
This study's planned enrollment of 344 is below the median of 400 across 228 interventional studies indexed under Whooping Cough.
Browse Whooping Cough studies →Tanabe Pharma Corporation is the lead sponsor of 92 studies on the registry; 1 is open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Subjects Who Should Receive A Vaccination With Care 4) applies only to the Main Cohort.
Exclusion Criteria:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects receive BK1803 administered according to the study vaccination schedule, including primary and booster immunizations.
Biological: BK1803
Subjects receive BK1803 administered according to the study vaccination schedule, including primary and booster immunizations.
Biological: BK1803
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
BK1803 is a combination vaccine administered intramuscularly according to the study vaccination schedule, including primary and booster immunizations.
GOBIK Aqueous Suspension Syringes is a combination vaccine administered intramuscularly according to the study vaccination schedule.
Bimmugen® Injection is a hepatitis B vaccine administered subcutaneously according to the study vaccination schedule.
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.
Time frame: 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.
Time frame: 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.
Time frame: 4 weeks from the post-primary immunization of GOBIK in Main Cohort (Visit4)
Geometric mean antibody titers for HBs antigen
Geometric mean antibody titers against hepatitis B surface (HBs) antigen will be evaluated.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Plan to share: No
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