DiphtheriaPhase 3NCT02118961
Study of BK1301 (DTaP Vaccine) as a Booster in Adolescents
A Phase 3 study testing Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301) and Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid) in people with Diphtheria and Tetanus, run by Tanabe Pharma Corporation at 7 sites in Japan.
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… Read more about this study
- Who is it for?
- Ages 11 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Tetanus, Pertussis
- What is being tested?
- Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301) and Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 446 participants
- Where
- 7 sitesJapan
- Study dates
- Apr 2014to Aug 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 11 or 12 years on the day of injection
- Received 3 or 4 doses of DTaP vaccine
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Japan7 sites
Investigational site
Fukuoka, Fukuoka
Investigational site
Hiroshima, Hiroshima
Investigational site
Itoshima-shi, Fukuoka
Investigational site
Kasuga-shi, Fukuoka
Inverstigational site
Kumagaya-shi, Saitama
Inverstigational site
Shinjuku-ku, Tokyo
Investigational site
Shizuoka, Shizuoka
About this study
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
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
- Being tested
- Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301), Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid)
- Keywords
- Diphtheria, Tetanus, Pertussis, DTaP vaccine, Adolescents
- Medical subject headings
- Diphtheria, Tetanus, Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301)Biological
Also called TRIBIK®
0.5 mL, subcutaneous injection
Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid)Biological
Also called DTBIK®
0.1 mL, subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| BK1301 | Experimental | Not described Receives: Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301) |
| DT toxoid | Active comparator | Not described Receives: Biological: Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pre-vaccination and 28-42 days after vaccination
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.
Measured: pre-vaccination and 28-42 days after vaccination
Secondary outcomes (7)
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.
Measured: 28-42 days after vaccination
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.
Measured: 28-42 days after vaccination
Geometric Mean Titers (GMTs) of Anti-D and Anti-T Antibodies
Measured: 28-42 days after vaccination
Geometric Mean Titers (GMTs) of Anti-PT and Anti-FHA Antibodies
Measured: 28-42 days after vaccination
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
Measured: pre vaccination and 28-42 days after vaccination
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
Measured: pre vaccination and 28-42 days after vaccination
Percentage of Participants With Adverse Events
Measured: 28-42 days following vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiphtheriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 446 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Research Foundation for Microbial Diseases of Osaka University
- Responsible party
- Sponsor
- Investigators
- Shintaro Okada, M.D., Ph.D., Study director, Osaka University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02118961
- Sponsor's protocol ID
- BKD1A
- Status last verified
- Dec 2025
- First submitted
- 13 Apr 2014
- Last updated
- 6 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02118961
- Acronym / sponsor ID
- BKD1A
- Conditions
- Diphtheria, Tetanus, Pertussis
- Keywords
- Diphtheria, Tetanus, Pertussis, DTaP vaccine, Adolescents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 446 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Collaborators
- The Research Foundation for Microbial Diseases of Osaka University
- Study start
- Apr 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 21 Apr 2014 (estimated)
- Results
- Posted 21 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BK1301 | Experimental | Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301) |
| DT toxoid | Active comparator | Biological: Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid) |
Who may qualify
- Ages
- 11 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 11 or 12 years on the day of injection
- Received 3 or 4 doses of DTaP vaccine
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301)Also: TRIBIK®0.5 mL, subcutaneous injection | Biological | BK1301 |
| Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid)Also: DTBIK®0.1 mL, subcutaneous injection | Biological | DT toxoid |
Primary outcome
Percentage of Participants With Booster Responses for Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibodies
Time frame: pre-vaccination and 28-42 days after vaccination
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
Time frame: pre-vaccination and 28-42 days after vaccination
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.
7 secondary outcomes
Percentage of Participants With Anti-D and Anti-T Antibody Titers Above Protocol Defined Cut-off Values
Time frame: 28-42 days after vaccination
Percentage of Participants With Anti-PT and Anti-FHA Antibody Titers Above Protocol Defined Cut-off Values
Time frame: 28-42 days after vaccination
Geometric Mean Titers (GMTs) of Anti-D and Anti-T Antibodies
Time frame: 28-42 days after vaccination
Geometric Mean Titers (GMTs) of Anti-PT and Anti-FHA Antibodies
Time frame: 28-42 days after vaccination
Geometric Mean Titer Ratios of Anti-D and Anti-T Antibodies
Time frame: pre vaccination and 28-42 days after vaccination
Geometric Mean Titer Ratios of Anti-PT and Anti-FHA Antibodies
Time frame: pre vaccination and 28-42 days after vaccination
Percentage of Participants With Adverse Events
Time frame: 28-42 days following vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shintaro Okada, M.D., Ph.D. study director
Osaka University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301) and Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid) in people with Diphtheria and Tetanus, run by Tanabe Pharma Corporation at 7 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Booster Responses for Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibodies (time frame: pre-vaccination and 28-42 days after vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.