Clinical Trial: Study of BK1803 in Healthy Infants

U.S., Aug. 29 -- ClinicalTrials.gov registry received information related to the study (NCT07793513) titled 'Study of BK1803 in Healthy Infants' on Aug. 17.

Brief 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.

Participants will be randomized to receive either BK1803 or a control regimen consisting of GOBIK Aqueous Suspension Syringes and Bimmugen(R) 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), pertus...