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

Tetanus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02118961
• Other study ID #: BKD1A
• 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

• Diphtheria
• Pertussis
• Tetanus
• Whooping Cough

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