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Study of BK1803 in Healthy Infants

NCT07793513 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 344

Last updated 2026-08-28

No results posted yet for this study

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® 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.

Conditions

Interventions

BIOLOGICAL

BK1803

BK1803 is a combination vaccine administered intramuscularly according to the study vaccination schedule, including primary and booster immunizations.

BIOLOGICAL

GOBIK Aqueous Suspension Syringes

GOBIK Aqueous Suspension Syringes is a combination vaccine administered intramuscularly according to the study vaccination schedule.

BIOLOGICAL

Bimmugen® Injection

Bimmugen® Injection is a hepatitis B vaccine administered subcutaneously according to the study vaccination schedule.

Sponsors & Collaborators

  • The Research Foundation for Microbial Diseases of Osaka University (BIKEN)

    collaborator UNKNOWN

  • Tanabe Pharma Corporation

    lead INDUSTRY

Principal Investigators

  • General Manager · Tanabe Pharma Corporation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2029-04-30
Completion
2029-04-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07793513 on ClinicalTrials.gov