search
Back to results

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

Primary Purpose

Diphtheria, Tetanus, Pertussis

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301)
Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid)
Sponsored by
Mitsubishi Tanabe Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diphtheria focused on measuring Diphtheria, Tetanus, Pertussis, DTaP vaccine, Adolescents

Eligibility Criteria

11 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site
  • Inverstigational site
  • Investigational site
  • Inverstigational site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BK1301

DT toxoid

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants With Booster Responses for Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibodies
Booster response was defined as post titer ≥ 0.4 IU/mL and post/pre titer ≥ 4 increase.
Percentage of Participants With Booster Responses for Anti-pertussis Toxoid (Anti-PT) and Anti-Filamentous Hemagglutinin (Anti-FHA) Antibodies
Booster response was defined as post titer ≥ 20 EU/mL and post/pre titer ≥ 4 increase in a subject with pre titer < 20 EU/mL, or post/pre titer ≥ 2 increase in a subject with pre titer ≥ 20 EU/mL.

Secondary Outcome Measures

Percentage of Participants With Anti-D and Anti-T Antibody Titers Above Protocol Defined Cut-off Values
Protocol defined cut-off values were 0.1 IU/mL for anti-D and 0.01 IU/mL for anti-T.
Percentage of Participants With Anti-PT and Anti-FHA Antibody Titers Above Protocol Defined Cut-off Values
Protocol defined cut-off values were 10 EU/mL.
Geometric Mean Titers (GMTs) of Anti-D and Anti-T Antibodies
Geometric Mean Titers (GMTs) of Anti-PT and Anti-FHA Antibodies
Geometric Mean Titer Ratios of Anti-D and Anti-T Antibodies
Ratios were calculated as 28-42 days after vaccination titers over pre vaccination titers
Geometric Mean Titer Ratios of Anti-PT and Anti-FHA Antibodies
Ratios were calculated as 28-42 days after vaccination titers over pre vaccination titers
Percentage of Participants With Adverse Events

Full Information

First Posted
April 13, 2014
Last Updated
November 24, 2016
Sponsor
Mitsubishi Tanabe Pharma Corporation
Collaborators
The Research Foundation for Microbial Diseases of Osaka University
search

1. Study Identification

Unique Protocol Identification Number
NCT02118961
Brief Title
Study of BK1301 (DTaP Vaccine) as a Booster in Adolescents
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation
Collaborators
The Research Foundation for Microbial Diseases of Osaka University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diphtheria, Tetanus, Pertussis
Keywords
Diphtheria, Tetanus, Pertussis, DTaP vaccine, Adolescents

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
446 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BK1301
Arm Type
Experimental
Arm Title
DT toxoid
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301)
Other Intervention Name(s)
TRIBIK®
Intervention Description
0.5 mL, subcutaneous injection
Intervention Type
Biological
Intervention Name(s)
Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid)
Other Intervention Name(s)
DTBIK®
Intervention Description
0.1 mL, subcutaneous injection
Primary Outcome Measure Information:
Title
Percentage of Participants With Booster Responses for Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibodies
Description
Booster response was defined as post titer ≥ 0.4 IU/mL and post/pre titer ≥ 4 increase.
Time Frame
pre-vaccination and 28-42 days after vaccination
Title
Percentage of Participants With Booster Responses for Anti-pertussis Toxoid (Anti-PT) and Anti-Filamentous Hemagglutinin (Anti-FHA) Antibodies
Description
Booster response was defined as post titer ≥ 20 EU/mL and post/pre titer ≥ 4 increase in a subject with pre titer < 20 EU/mL, or post/pre titer ≥ 2 increase in a subject with pre titer ≥ 20 EU/mL.
Time Frame
pre-vaccination and 28-42 days after vaccination
Secondary Outcome Measure Information:
Title
Percentage of Participants With Anti-D and Anti-T Antibody Titers Above Protocol Defined Cut-off Values
Description
Protocol defined cut-off values were 0.1 IU/mL for anti-D and 0.01 IU/mL for anti-T.
Time Frame
28-42 days after vaccination
Title
Percentage of Participants With Anti-PT and Anti-FHA Antibody Titers Above Protocol Defined Cut-off Values
Description
Protocol defined cut-off values were 10 EU/mL.
Time Frame
28-42 days after vaccination
Title
Geometric Mean Titers (GMTs) of Anti-D and Anti-T Antibodies
Time Frame
28-42 days after vaccination
Title
Geometric Mean Titers (GMTs) of Anti-PT and Anti-FHA Antibodies
Time Frame
28-42 days after vaccination
Title
Geometric Mean Titer Ratios of Anti-D and Anti-T Antibodies
Description
Ratios were calculated as 28-42 days after vaccination titers over pre vaccination titers
Time Frame
pre vaccination and 28-42 days after vaccination
Title
Geometric Mean Titer Ratios of Anti-PT and Anti-FHA Antibodies
Description
Ratios were calculated as 28-42 days after vaccination titers over pre vaccination titers
Time Frame
pre vaccination and 28-42 days after vaccination
Title
Percentage of Participants With Adverse Events
Time Frame
28-42 days following vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shintaro Okada, M.D., Ph.D.
Organizational Affiliation
Osaka University
Official's Role
Study Director
Facility Information:
Facility Name
Investigational site
City
Fukuoka-shi
State/Province
Fukuoka
Country
Japan
Facility Name
Investigational site
City
Itoshima-shi
State/Province
Fukuoka
Country
Japan
Facility Name
Investigational site
City
Kasuga-shi
State/Province
Fukuoka
Country
Japan
Facility Name
Investigational site
City
Hiroshima-shi
State/Province
Hiroshima
Country
Japan
Facility Name
Inverstigational site
City
Kumagaya-shi
State/Province
Saitama
Country
Japan
Facility Name
Investigational site
City
Shizuoka-shi
State/Province
Shizuoka
Country
Japan
Facility Name
Inverstigational site
City
Shinjuku-ku
State/Province
Tokyo
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs