Study of BK1803 in Healthy Infants

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.

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.

Inclusion Criteria:

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

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.

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