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

NCT02118961 | Completed Phase 3 Results

• 1 other identifier: BKD1A
• Study Type: interventional
• Target: 446
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Diphtheria; Tetanus; Pertussis

Keywords

Diphtheria; Tetanus; Pertussis; DTaP vaccine; Adolescents

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Booster Responses for Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibodies

  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

  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 Outcomes (7)

• Percentage of Participants With Anti-D and Anti-T Antibody Titers Above Protocol Defined Cut-off Values

  28-42 days after vaccination

• Percentage of Participants With Anti-PT and Anti-FHA Antibody Titers Above Protocol Defined Cut-off Values

  28-42 days after vaccination

• Geometric Mean Titers (GMTs) of Anti-D and Anti-T Antibodies

  28-42 days after vaccination

• Geometric Mean Titers (GMTs) of Anti-PT and Anti-FHA Antibodies

  28-42 days after vaccination

• Geometric Mean Titer Ratios of Anti-D and Anti-T Antibodies

  pre vaccination and 28-42 days after vaccination

Study Arms (2)

BK1301

EXPERIMENTAL

Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301)

DT toxoid

ACTIVE COMPARATOR

Biological: Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid)

Interventions

Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid) BIOLOGICAL

0.1 mL, subcutaneous injection

Also known as: DTBIK®

DT toxoid

Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301) BIOLOGICAL

0.5 mL, subcutaneous injection

Also known as: TRIBIK®

BK1301

Eligibility Criteria

• Age: 11 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead
• The Research Foundation for Microbial Diseases of Osaka University: collaborator

Study Sites (7)

Investigational site

Fukuoka, Fukuoka, Japan

Location

Investigational site

Itoshima-shi, Fukuoka, Japan

Location

Investigational site

Kasuga-shi, Fukuoka, Japan

Location

Investigational site

Hiroshima, Hiroshima, Japan

Location

Inverstigational site

Kumagaya-shi, Saitama, Japan

Location

Investigational site

Shizuoka, Shizuoka, Japan

Location

Inverstigational site

Shinjuku-ku, Tokyo, Japan

Location

MeSH Terms

Conditions

Diphtheria; Tetanus; Whooping Cough

Interventions

Tetanus Toxoid; Diphtheria-Tetanus-acellular Pertussis Vaccines

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Toxoids; Vaccines; Biological Products; Complex Mixtures; Pertussis Vaccine; Bacterial Vaccines; Diphtheria Toxoid; Vaccines, Combined; Vaccines, Acellular; Vaccines, Subunit

Results Point of Contact

• Title: Clinical Trials, Information Desk / Clinical Development counter
• Organization: Tanabe Pharma Corporation / The Research Foundation for Microbial Diseases of Osaka University

cti-inq-ml.JP@ml.tanabe-pharma.com/clinicaldevelopment@mail.biken.or.jp

Study Officials

• Shintaro Okada, M.D., Ph.D.

  Osaka University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2014
• First Posted: April 21, 2014
• Study Start: April 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: January 6, 2026
• Results First Posted: November 21, 2016

Record last verified: 2025-12

Locations

JP (7)