CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 446 enrolled
Drug / intervention
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301) +1 morebiological
Likely dose
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301) 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02118961
NCT02118961Phase 3Completed
CompareCT.gov

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

Tanabe Pharma Corporation·interventional·Posted Apr 21, 2014·Updated Jan 6, 2026

In Brief

A Phase 3 clinical trial evaluating Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301) and Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid) for Diphtheria and 2 related conditions. Completed, enrolled 446 participants across 7 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiphtheria, Tetanus, Pertussis
CountriesJapan
CollaboratorsThe Research Foundation for Microbial Diseases of Osaka University

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 21, 2014
Enrollment StartApr 1, 2014
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 12.2 years ago

Interventions

Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301)biological

0.5 mL, subcutaneous injection

Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid)biological

0.1 mL, subcutaneous injection