We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02118961
First Posted: April 21, 2014
Last Update Posted: January 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Research Foundation for Microbial Diseases of Osaka University
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
  Purpose

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

Condition Intervention Phase
Diphtheria Tetanus Pertussis Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301) Biological: Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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

Resource links provided by NLM:


Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • 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.

  • 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 Outcome Measures:
  • 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.

  • 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.

  • Geometric Mean Titers (GMTs) of Anti-D and Anti-T Antibodies [ Time Frame: 28-42 days after vaccination ]
  • Geometric Mean Titers (GMTs) of Anti-PT and Anti-FHA Antibodies [ Time Frame: 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

  • 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

  • Percentage of Participants With Adverse Events [ Time Frame: 28-42 days following vaccination ]

Enrollment: 446
Study Start Date: April 2014
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BK1301 Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301)
0.5 mL, subcutaneous injection
Other Name: TRIBIK®
Active Comparator: DT toxoid Biological: Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid)
0.1 mL, subcutaneous injection
Other Name: DTBIK®

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   11 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02118961


Locations
Japan
Investigational site
Fukuoka-shi, Fukuoka, Japan
Investigational site
Itoshima-shi, Fukuoka, Japan
Investigational site
Kasuga-shi, Fukuoka, Japan
Investigational site
Hiroshima-shi, Hiroshima, Japan
Inverstigational site
Kumagaya-shi, Saitama, Japan
Investigational site
Shizuoka-shi, Shizuoka, Japan
Inverstigational site
Shinjuku-ku, Tokyo, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
The Research Foundation for Microbial Diseases of Osaka University
Investigators
Study Director: Shintaro Okada, M.D., Ph.D. Osaka University
  More Information

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT02118961     History of Changes
Other Study ID Numbers: BKD1A
First Submitted: April 13, 2014
First Posted: April 21, 2014
Results First Submitted: May 16, 2016
Results First Posted: November 21, 2016
Last Update Posted: January 13, 2017
Last Verified: September 2016

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Diphtheria
Tetanus
Pertussis
DTaP vaccine
Adolescents

Additional relevant MeSH terms:
Whooping Cough
Tetanus
Tetany
Diphtheria
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Signs and Symptoms
Corynebacterium Infections
Actinomycetales Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs