Study of BK1301 (DTaP Vaccine) as a Booster in Adolescents
NCT ID: NCT02118961
Last Updated: 2026-01-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
446 participants
INTERVENTIONAL
2014-04-30
2014-08-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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BK1301
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301)
0.5 mL, subcutaneous injection
DT toxoid
Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid)
0.1 mL, subcutaneous injection
Interventions
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Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301)
0.5 mL, subcutaneous injection
Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid)
0.1 mL, subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Received 3 or 4 doses of DTaP vaccine
Exclusion Criteria
* 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
11 Years
12 Years
ALL
Yes
Sponsors
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The Research Foundation for Microbial Diseases of Osaka University
OTHER
Tanabe Pharma Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Shintaro Okada, M.D., Ph.D.
Role: STUDY_DIRECTOR
Osaka University
Locations
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Investigational site
Fukuoka, Fukuoka, Japan
Investigational site
Itoshima-shi, Fukuoka, Japan
Investigational site
Kasuga-shi, Fukuoka, Japan
Investigational site
Hiroshima, Hiroshima, Japan
Inverstigational site
Kumagaya-shi, Saitama, Japan
Investigational site
Shizuoka, Shizuoka, Japan
Inverstigational site
Shinjuku-ku, Tokyo, Japan
Countries
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Other Identifiers
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BKD1A
Identifier Type: -
Identifier Source: org_study_id
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