A Phase 3 interventional study of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301) and Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid) in Diphtheria, Tetanus and Pertussis, sponsored by Tanabe Pharma Corporation. Completed at 7 sites in Japan. Open to participants aged 11 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-06.
Sponsored by Tanabe Pharma Corporation · Phase 3, Interventional, and Prevention
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:
267 studies on the registry are indexed under Diphtheria; 17 are open to participants now.
This study's enrollment of 446 is close to the median of 448 across 241 interventional studies indexed under Diphtheria.
Browse Diphtheria studies →Tanabe Pharma Corporation is the lead sponsor of 92 studies on the registry; 1 is open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.
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Exclusion Criteria:
Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301)
Biological: Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid)
0.5 mL, subcutaneous injection
Also known as: TRIBIK®
0.1 mL, subcutaneous injection
Also known as: DTBIK®
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.
Time frame: 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.
Time frame: pre-vaccination and 28-42 days after vaccination
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.
Time frame: 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.
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
Ratios were calculated as 28-42 days after vaccination titers over pre vaccination titers
Time frame: 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
Time frame: pre vaccination and 28-42 days after vaccination
Percentage of Participants With Adverse Events
Time frame: 28-42 days following vaccination
| Milestone | BK1301 | DT Toxoid |
|---|---|---|
| Started | 224 | 222 |
| Completed | 223 | 222 |
| Not completed | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
Booster response was defined as post titer ≥ 0.4 IU/mL and post/pre titer ≥ 4 increase.
| percentage of Participants | BK1301 | DT Toxoid |
|---|---|---|
| anti-D | 100.0 (98.4 to 100.0) | 99.5 (97.5 to 100.0) |
| anti-T | 98.7 (96.1 to 99.7) | 97.3 (94.2 to 99.0) |
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.
| percentage of Participants | BK1301 |
|---|---|
| anti-PT | 91.0 (86.5 to 94.4) |
| anti-FHA | 91.5 (87.0 to 94.8) |
Protocol defined cut-off values were 0.1 IU/mL for anti-D and 0.01 IU/mL for anti-T.
| percentage of Participants | BK1301 | DT Toxoid |
|---|---|---|
| anti-D | 100.0 (98.4 to 100.0) | 100.0 (98.4 to 100.0) |
| anti-T | 100.0 (98.4 to 100.0) | 100.0 (98.4 to 100.0) |
Protocol defined cut-off values were 10 EU/mL.
| percentage of Participants | BK1301 |
|---|---|
| anti-PT | 100.0 (98.4 to 100.0) |
| anti-FHA | 100.0 (98.4 to 100.0) |
| IU/mL | BK1301 | DT Toxoid |
|---|---|---|
| anti-D | 20.856 (18.221 to 23.872) | 15.581 (13.748 to 17.658) |
| anti-T | 13.378 (11.838 to 15.118) | 11.638 (10.348 to 13.090) |
| EU/mL | BK1301 |
|---|---|
| anti-PT | 241.15 (210.65 to 276.07) |
| anti-FHA | 344.46 (309.72 to 383.10) |
Ratios were calculated as 28-42 days after vaccination titers over pre vaccination titers
| titer ratio | BK1301 | DT Toxoid |
|---|---|---|
| anti-D | 137.5 (107.8 to 175.5) | 106.3 (83.9 to 134.7) |
| anti-T | 47.9 (38.9 to 59.0) | 44.3 (36.4 to 53.9) |
Ratios were calculated as 28-42 days after vaccination titers over pre vaccination titers
| titer ratio | BK1301 |
|---|---|
| anti-PT | 12.6 (10.5 to 15.2) |
| anti-FHA | 8.5 (7.2 to 10.0) |
| percentage of participants | BK1301 | DT Toxoid |
|---|---|---|
| Percentage of Participants With Adverse Events | 90.1 | 89.6 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BK1301 | — | 0/223 (0%) | 200/223 (89.7%) |
| DT Toxoid | — | 0/222 (0%) | 194/222 (87.4%) |
| Event | BK1301 | DT Toxoid |
|---|---|---|
| Injection site erythemaGeneral disorders | 167/223 | 160/222 |
| Injection site swellingGeneral disorders | 162/223 | 148/222 |
| Injection site pruritusGeneral disorders | 132/223 | 113/222 |
| Injection site painGeneral disorders | 125/223 | 85/222 |
| Injection site warmthGeneral disorders | 115/223 | 87/222 |
| Injection site indurationGeneral disorders | 95/223 | 84/222 |
| HeadacheNervous system disorders | 17/223 | 13/222 |
| NasopharyngitisInfections and infestations | 12/223 | 15/222 |
| PyrexiaGeneral disorders | 15/223 | 3/222 |
| Age, Categorical(Participants) | BK1301 | DT Toxoid | Total |
|---|---|---|---|
| <=18 years | 224 | 222 | 446 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | BK1301 | DT Toxoid | Total |
|---|---|---|---|
| Female | 113 | 104 | 217 |
| Male | 111 | 118 | 229 |
The record gives a start of Apr 2014, a primary completion of Aug 2014 and a completion of Aug 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2016, 2 years 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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