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

NCT02118961 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 446

Last updated 2026-01-06

Study results available
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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

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

Sponsors & Collaborators

  • The Research Foundation for Microbial Diseases of Osaka University

    collaborator OTHER

  • Tanabe Pharma Corporation

    lead INDUSTRY

Principal Investigators

  • Shintaro Okada, M.D., Ph.D. · Osaka University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02118961 on ClinicalTrials.gov