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Completed

NCT Number: NCT02118961

Study of BK1301 (DTaP Vaccine) 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

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Key information

Conditions

Diphtheria Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Bordetella Infections Clostridium Infections Corynebacterium Infections Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Infections Pertussis Respiratory Tract Diseases Respiratory Tract Infections Tetanus Whooping Cough

Age range

11 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational site, Fukuoka, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Biological

0.5 mL, subcutaneous injection

Other names: TRIBIK®

Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid)

Biological

0.1 mL, subcutaneous injection

Other names: DTBIK®

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

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

    Time frame: 28-42 days after vaccination

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

    Time frame: 28-42 days after vaccination

  5. 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

  6. 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

  7. Percentage of Participants With Adverse Events

    Time frame: 28-42 days following vaccination

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Collaborators

  • The Research Foundation for Microbial Diseases of Osaka University

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 21, 2014
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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