NCT02118961

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

Confirmatory Study to Evaluate the Immunogenicity of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP Vaccine, BK1301) as a Booster in Adolescents

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 446 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 11 Years – 12 Years
• Healthy volunteers: Accepted

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

Conditions

• Diphtheria
• Tetanus
• Pertussis

Interventions

Type	Name	Description
BIOLOGICAL	Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301)	0.5 mL, subcutaneous injection
BIOLOGICAL	Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid)	0.1 mL, subcutaneous injection

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2014-04-21
• Last updated: 2026-01-06
• Results posted: 2016-11-21

Locations

7 sites across 1 country: Japan