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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
The Research Foundation for Microbial Diseases of Osaka University
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT02118961
First received: April 13, 2014
Last updated: August 12, 2014
Last verified: August 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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-D and anti-T antibodies [ Time Frame: pre-vaccination and 28-42 days after vaccination ] [ Designated as safety issue: No ]
  • Percentage of participants with booster responses for anti-PT and anti-FHA antibodies [ Time Frame: pre-vaccination and 28-42 days after vaccination ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Percentage of participants with anti-PT and anti-FHA antibody titers above protocol defined cut-off values [ Time Frame: 28-42 days after vaccination ] [ Designated as safety issue: No ]
  • Geometric mean titers (GMTs) of anti-D and anti-T antibodies [ Time Frame: 28-42 days after vaccination ] [ Designated as safety issue: No ]
  • GMTs of anti-PT and anti-FHA antibodies [ Time Frame: 28-42 days after vaccination ] [ Designated as safety issue: No ]
  • Increase in GMTs of anti-D and anti-T antibodies [ Time Frame: pre-vaccination and 28-42 days after vaccination ] [ Designated as safety issue: No ]
  • Increase in GMTs of anti-PT and anti-FHA antibodies [ Time Frame: pre-vaccination and 28-42 days after vaccination ] [ Designated as safety issue: No ]
  • Percentage of participants with Adverse Events [ Time Frame: 28-42 days following vaccination ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 430
Study Start Date: April 2014
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 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

Ages Eligible for Study:   11 Years to 12 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT02118961     History of Changes
Other Study ID Numbers: BKD1A
Study First Received: April 13, 2014
Last Updated: August 12, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

Additional relevant MeSH terms:
Whooping Cough
Tetanus
Diphtheria
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections

ClinicalTrials.gov processed this record on September 22, 2014