Study of BK1301 (DTaP Vaccine) as a Booster in Adolescents

December 15, 2025 updated by: Tanabe Pharma Corporation

Confirmatory Study to Evaluate the Immunogenicity of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP Vaccine, BK1301) as a Booster in Adolescents

This study is designed to assess the immunogenicity and safety of DTaP vaccine (BK1301) as a booster dose in adolescents.

The purposes of this study are as follows:

  • To confirm the non-inferiority of BK1301 to Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid) with respect to booster responses for anti-diphtheria toxoid (anti-D) and anti-tetanus toxoid (anti-T) antibodies
  • To confirm that booster responses for anti-pertussis toxoid (anti-PT) and anti-Filamentous Hemagglutinin (anti-FHA) antibodies are more than 80% of participants received BK1301

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

446

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Fukuoka
      • Fukuoka, Fukuoka, Japan
        • Investigational Site
      • Itoshima-shi, Fukuoka, Japan
        • Investigational Site
      • Kasuga-shi, Fukuoka, Japan
        • Investigational Site
    • Hiroshima
      • Hiroshima, Hiroshima, Japan
        • Investigational Site
    • Saitama
      • Kumagaya-shi, Saitama, Japan
        • Inverstigational site
    • Shizuoka
      • Shizuoka, Shizuoka, Japan
        • Investigational Site
    • Tokyo
      • Shinjuku-ku, Tokyo, Japan
        • Inverstigational site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 11 or 12 years on the day of injection
  • Received 3 or 4 doses of DTaP vaccine

Exclusion Criteria:

  • History of pertussis, diphtheria, tetanus
  • History of anaphylaxis to vaccine components
  • Serious conditions or diseases of the heart, vein, blood, respiratory, hepar, kidney, digestive system, psychiatric or nervous system
  • Transfused or received gamma globulin within 3 months, or received high-dose gamma globulin within 6 months before the day of injection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BK1301
Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301)
0.5 mL, subcutaneous injection
Other Names:
  • TRIBIK®
Active Comparator: DT toxoid
Biological: Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid)
0.1 mL, subcutaneous injection
Other Names:
  • DTBIK®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Booster Responses for Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibodies
Time Frame: pre-vaccination and 28-42 days after vaccination
Booster response was defined as post titer ≥ 0.4 IU/mL and post/pre titer ≥ 4 increase.
pre-vaccination and 28-42 days after vaccination
Percentage of Participants With Booster Responses for Anti-pertussis Toxoid (Anti-PT) and Anti-Filamentous Hemagglutinin (Anti-FHA) Antibodies
Time Frame: pre-vaccination and 28-42 days after vaccination
Booster response was defined as post titer ≥ 20 EU/mL and post/pre titer ≥ 4 increase in a subject with pre titer < 20 EU/mL, or post/pre titer ≥ 2 increase in a subject with pre titer ≥ 20 EU/mL.
pre-vaccination and 28-42 days after vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Anti-D and Anti-T Antibody Titers Above Protocol Defined Cut-off Values
Time Frame: 28-42 days after vaccination
Protocol defined cut-off values were 0.1 IU/mL for anti-D and 0.01 IU/mL for anti-T.
28-42 days after vaccination
Percentage of Participants With Anti-PT and Anti-FHA Antibody Titers Above Protocol Defined Cut-off Values
Time Frame: 28-42 days after vaccination
Protocol defined cut-off values were 10 EU/mL.
28-42 days after vaccination
Geometric Mean Titers (GMTs) of Anti-D and Anti-T Antibodies
Time Frame: 28-42 days after vaccination
28-42 days after vaccination
Geometric Mean Titers (GMTs) of Anti-PT and Anti-FHA Antibodies
Time Frame: 28-42 days after vaccination
28-42 days after vaccination
Geometric Mean Titer Ratios of Anti-D and Anti-T Antibodies
Time Frame: pre vaccination and 28-42 days after vaccination
Ratios were calculated as 28-42 days after vaccination titers over pre vaccination titers
pre vaccination and 28-42 days after vaccination
Geometric Mean Titer Ratios of Anti-PT and Anti-FHA Antibodies
Time Frame: pre vaccination and 28-42 days after vaccination
Ratios were calculated as 28-42 days after vaccination titers over pre vaccination titers
pre vaccination and 28-42 days after vaccination
Percentage of Participants With Adverse Events
Time Frame: 28-42 days following vaccination
28-42 days following vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanabe Pharma Corporation

Collaborators

The Research Foundation for Microbial Diseases of Osaka University

Investigators

  • Study Director: Shintaro Okada, M.D., Ph.D., Osaka University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

April 13, 2014

First Submitted That Met QC Criteria

April 18, 2014

First Posted (Estimated)

April 21, 2014

Study Record Updates

Last Update Posted (Estimated)

January 6, 2026

Last Update Submitted That Met QC Criteria

December 15, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BKD1A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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