Confirmatory Study of BK1803 in Healthy Infants (comparative study using GOBIK Aqueous Suspension Syringes and Bimmugen(R) Injection as a control)
Study of BK1803 in Healthy Infants
Maruyama Nobuko
Tanabe Pharma Corporation
1-1-1, Marunouchi Chiyoda-ku, Tokyo
+81-120-753-280
cti-inq-ml.JP@ml.tanabe-pharma.com
Clinical Trials Information Desk
Tanabe Pharma Corporation
1-1-1, Marunouchi Chiyoda-ku, Tokyo
+81-120-753-280
cti-inq-ml.JP@ml.tanabe-pharma.com
Pending
Sept. 01, 2026
344
Interventional
randomized controlled trial
single blind
active control
parallel assignment
prevention purpose
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.
(1) 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.
(2) 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.
1) Subjects who clearly have underlying diseases, such as cardiovascular disease, kidney disease, liver disease, blood disease, respiratory disease, or a developmental disorder
2) Subjects who have developed a pyrexia within 2 days after receiving a vaccination in the past
3) Subjects with a past history of convulsions
4) (Main Cohort only) Subjects with the gestational age <37 weeks, or who weighed less than 2500 g at birth
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.
(1) Subjects who have received diagnoses of immunodeficiencies in the past, or who are currently receiving treatments that cause immunosuppression
(2) Subjects with close relatives (up to third degree of kinship) who have a congenital immunodeficiency
(3) Subjects who might experience a serious allergy in response to a food, drug product (especially any component of the study drug), etc.
(4) Subjects who have had Haemophilus Influenzae type b (Hib) infections, pertussis, diphtheria, tetanus, acute poliomyelitis, or hepatitis B in the past
(5) Subjects who have received a vaccination against Hib, pertussis, diphtheria, tetanus, polio, or hepatitis B in the past
(6) Subjects who have received hepatitis B immunoglobulin (HBIG) for the prevention of vertical infection in the past
(7) 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
(8) Subjects who are receiving anticoagulant therapy or who have thrombocytopenia or coagulation disorder
(9) Subjects with fibrodysplasia ossificans progressiva
(10) Subjects who have received live vaccines within 27 days before the first vaccination with the study drug
(11) Subjects who have received inactivated vaccines/toxoids or mRNA vaccines within 6 days before the first vaccination with the study drug
(12) Subjects who have received blood transfusions, immunosuppressants (except for topical drugs), or immunoglobulin preparations in the past
(13) 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
(14) Subjects who have participated in another clinical study and received another study drug within 12 weeks before obtaining informed consent
(15) (Safety Lead-in Cohort only) Subjects with the gestational age <37 weeks, or who weighed less than 2500 g at birth
(16) Subjects otherwise judged to be unsuitable for participation in this study by the (sub)investigator
0age 2month old over
0age 7month old not
Both
Prevention:pertussis, diphtheria, tetanus, poliomyelitis, hepatitis B, Haemophilus influenzae type b
(1) BK1803 group
For the primary immunization, participants will receive 3 intramuscular doses (as a rule, administered in the anterolateral thigh) of 0.5 mL at intervals of 27 to 56 days. For the booster immunization, participants will receive a single intramuscular dose (as a rule, administered in the anterolateral thigh) of 0.5 mL at 6 to 18 months after the primary immunization. The repeated vaccination with study drug at the same location as that which was used for the previous dose will be avoided.
(2) Control group
As for GOBIK Aqueous Suspension Syringes, participants will receive 3 intramuscular doses (as a rule, administered in the anterolateral thigh) of 0.5 mL at intervals of 27 to 56 days for the primary immunization. For the booster immunization, participants will receive a single intramuscular dose (as a rule, administered in the anterolateral thigh) of 0.5 mL at 6 to 18 months after the primary immunization.
As for Bimmugen(R) Injection, participants will receive 2 subcutaneous doses (as a rule, administered at the upper arm extensor) of 0.25 mL at intervals of at least 27 days, and a single subcutaneous dose of 0.25 mL at an interval of 139 to 167 days after the first vaccination.
For both control drugs, the repeated vaccination at the same location as that which was used for the previous dose will be avoided.
1) Main Cohort
- BK1803 group:
- The antibody seroprotection rates against HBs antigen, PRP, Bordetella pertussis (PT and FHA), diphtheria toxin, tetanus toxin, and attenuated poliovirus at Visit 4
- Control group:
- The antibody seroprotection rate against HBs antigen at Visit 6
- The antibody seroprotection rates against PRP, Bordetella pertussis (PT and FHA), diphtheria toxin, tetanus toxin, and attenuated poliovirus at Visit 4
1) Safety Lead-in Cohort
- The antibody seroprotection rates against HBs antigen, PRP, Bordetella pertussis (PT and FHA), diphtheria toxin, tetanus toxin, and attenuated poliovirus at Visits 4 and 8
- The geometric mean antibody titers for HBs antigen, PRP, Bordetella pertussis (PT and FHA), diphtheria toxin, tetanus toxin, and attenuated poliovirus at Visits 4 and 8
2) Main Cohort
- BK1803 group:
- The geometric mean antibody titers for HBs antigen, PRP, Bordetella pertussis (PT and FHA), diphtheria toxin, tetanus toxin, and attenuated poliovirus at Visits 4 and 8
- The antibody seroprotection rates against HBs antigen, PRP, Bordetella pertussis (PT and FHA), diphtheria toxin, tetanus toxin, and attenuated poliovirus at Visit 8
- Control group:
- The geometric mean antibody titer for HBs antigen at Visit 6
- The geometric mean antibody titers for PRP, Bordetella pertussis (PT and FHA), diphtheria toxin, tetanus toxin, and attenuated poliovirus at Visits 4 and 8
- The antibody seroprotection rates against PRP, Bordetella pertussis (PT and FHA), diphtheria toxin, tetanus toxin, and attenuated poliovirus at Visit 8
Tanabe Pharma Corporation
The Research Foundation for Microbial Diseases of Osaka University
IRB administrated by General incorporated association of ethic committee for clinical trials
