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

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ClinicalTrials.gov Identifier: NCT02118961
Recruitment Status : Completed
First Posted : April 21, 2014
Results First Posted : November 21, 2016
Last Update Posted : January 13, 2017
Sponsor:
Collaborator:
The Research Foundation for Microbial Diseases of Osaka University
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Study Description
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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

Condition or disease Intervention/treatment 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 446 participants
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
Study Start Date : April 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

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Arms and Interventions
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Arm Intervention/treatment
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®


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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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
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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
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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
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Study Director: Shintaro Okada, M.D., Ph.D. Osaka University
More Information
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Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT02118961    
Other Study ID Numbers: BKD1A
First Posted: April 21, 2014    Key Record Dates
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:
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Whooping Cough
Tetanus
Diphtheria
Tetany
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Clostridium Infections
 Gram-Positive Bacterial Infections
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Corynebacterium Infections
Actinomycetales Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs