Study of BK1803 in Healthy Infants

Sponsor
Tanabe Pharma Corporation
Study ID
NCT07793513
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Diphtheria
  • Haemophilus Influenzae Type b
  • Hepatitis B
  • Pertussis
  • Poliomyelitis
  • Tetanus

Eligibility Criteria

Sex
ALL
Age
2 Months - 6 Months
Healthy Volunteers
Accepted

Interventions

  • BK1803 — BIOLOGICAL
    BK1803 is a combination vaccine administered intramuscularly according to the study vaccination schedule, including primary and booster immunizations.
  • GOBIK Aqueous Suspension Syringes — BIOLOGICAL
    GOBIK Aqueous Suspension Syringes is a combination vaccine administered intramuscularly according to the study vaccination schedule.
  • Bimmugen® Injection — BIOLOGICAL
    Bimmugen® Injection is a hepatitis B vaccine administered subcutaneously according to the study vaccination schedule.

Study Details

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.

Key Dates

First listed
Aug 28, 2026
Start date
Oct 31, 2026
Status verified
Aug 2026
Primary completion
Apr 30, 2029
Completion
Apr 30, 2029

Study Design

Enrollment
344 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Safety Lead-in Cohort: BK1803
    Subjects receive BK1803 administered according to the study vaccination schedule, including primary and booster immunizations.
  • Experimental: Main Cohort: BK1803
    Subjects receive BK1803 administered according to the study vaccination schedule, including primary and booster immunizations.
  • Active Comparator: Main Cohort: Control (GOBIK and Bimmugen)
    Subjects receive control vaccines consisting of GOBIK Aqueous Suspension Syringes and Bimmugen® Injection according to the study vaccination schedule, including primary and booster immunizations.

Primary Outcome Measure

Antibody seroprotection rates against vaccine antigens in the BK1803 of Main Cohort [ Time Frame: 4 weeks from the post-primary immunization of BK1803 in Main Cohort (Visit4) ]

Central Contacts

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