Study of BK1803 in Healthy Infants

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 studyaims to assess whether BK1803 provides immunogenicity comparable to standard vaccinationregimens.The study consists of two cohorts: a safety lead‐in cohort and a main cohort. In thesafety lead‐in cohort, participants receive BK1803 to evaluate its initial safety andtolerability before initiating the main cohort. In the main cohort, participants arerandomized in a 1:1 ratio to receive either BK1803 or a control regimen consisting ofGOBIK Aqueous Suspension Syringes and Bimmugen® Injection.Participants will receive primary and booster immunizations according to the studyschedule, and immunogenicity will be evaluated based on antibody responses to multiplevaccine antigens. Safety will be monitored throughout the study period.