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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02118961
Other study ID # BKD1A
Secondary ID
Status Completed
Phase Phase 3
First received April 13, 2014
Last updated October 28, 2014
Start date April 2014
Est. completion date August 2014

Study information

Verified date October 2014
Source Mitsubishi Tanabe Pharma Corporation
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 446
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 11 Years to 12 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
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

Locations

Country Name City State
Japan Investigational site Fukuoka-shi Fukuoka
Japan Investigational site Hiroshima-shi Hiroshima
Japan Investigational site Itoshima-shi Fukuoka
Japan Investigational site Kasuga-shi Fukuoka
Japan Inverstigational site Kumagaya-shi Saitama
Japan Inverstigational site Shinjuku-ku Tokyo
Japan Investigational site Shizuoka-shi Shizuoka

Sponsors (2)

Lead Sponsor Collaborator
Mitsubishi Tanabe Pharma Corporation The Research Foundation for Microbial Diseases of Osaka University

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of participants with booster responses for anti-D and anti-T antibodies pre-vaccination and 28-42 days after vaccination No
Primary Percentage of participants with booster responses for anti-PT and anti-FHA antibodies pre-vaccination and 28-42 days after vaccination No
Secondary Percentage of participants with anti-D and anti-T antibody titers above protocol defined cut-off values 28-42 days after vaccination No
Secondary Percentage of participants with anti-PT and anti-FHA antibody titers above protocol defined cut-off values 28-42 days after vaccination No
Secondary Geometric mean titers (GMTs) of anti-D and anti-T antibodies 28-42 days after vaccination No
Secondary GMTs of anti-PT and anti-FHA antibodies 28-42 days after vaccination No
Secondary Increase in GMTs of anti-D and anti-T antibodies pre-vaccination and 28-42 days after vaccination No
Secondary Increase in GMTs of anti-PT and anti-FHA antibodies pre-vaccination and 28-42 days after vaccination No
Secondary Percentage of participants with Adverse Events 28-42 days following vaccination Yes
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