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Study of BK1803 in Healthy Infants

Name: Study of BK1803 in Healthy Infants — clinical trial record (NCT07793513)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusNot Yet Recruiting

PhasePhase 3

SponsorTanabe Pharma Corporation

Started2026-10

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Tanabe Pharma Corporation

83 trials monitored

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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.

Trial Details

NCT Number	NCT07793513
Lead Sponsor	Tanabe Pharma Corporation Collaborators: The Research Foundation for Microbial Diseases of Osaka University (BIKEN)
Conditions	Pertussis, Diphtheria, Tetanus, Poliomyelitis, Hepatitis B, Haemophilus Influenzae Type b
Enrollment	344 participants
Start Date	2026-10
Primary Completion	2029-04 (estimated)
Study Completion	2029-04 (estimated)
Updated on ClinicalTrials.gov	2026-08-28