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| Name | Class |
|---|---|
| The Research Foundation for Microbial Diseases of Osaka University | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BK1301 | Experimental |
| |
| DT toxoid | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301) | Biological | 0.5 mL, subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | pre-vaccination and 28-42 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 28-42 days after vaccination |
| Percentage of Participants With Anti-PT and Anti-FHA Antibody Titers Above Protocol Defined Cut-off Values |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shintaro Okada, M.D., Ph.D. | Osaka University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational site | Fukuoka | Fukuoka | Japan | |||
| Investigational site |
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| ID | Title | Description |
|---|---|---|
| FG000 | BK1301 | Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection |
| FG001 | DT Toxoid | Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid) | Biological | 0.1 mL, subcutaneous injection |
|
|
Protocol defined cut-off values were 10 EU/mL. |
| 28-42 days after vaccination |
| Geometric Mean Titers (GMTs) of Anti-D and Anti-T Antibodies | 28-42 days after vaccination |
| Geometric Mean Titers (GMTs) of Anti-PT and Anti-FHA Antibodies | 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 | 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 | pre vaccination and 28-42 days after vaccination |
| Percentage of Participants With Adverse Events | 28-42 days following vaccination |
| Itoshima-shi |
| Fukuoka |
| Japan |
| Investigational site | Kasuga-shi | Fukuoka | Japan |
| Investigational site | Hiroshima | Hiroshima | Japan |
| Inverstigational site | Kumagaya-shi | Saitama | Japan |
| Investigational site | Shizuoka | Shizuoka | Japan |
| Inverstigational site | Shinjuku-ku | Tokyo | Japan |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BK1301 | Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection |
| BG001 | DT Toxoid | Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | 95% Confidence Interval | percentage of Participants | pre-vaccination and 28-42 days after vaccination |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | 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. | The Outcome Measure was only pre-specified for the BK1301 Arm/Group. | Posted | Number | 95% Confidence Interval | percentage of Participants | pre-vaccination and 28-42 days after vaccination |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Number | 95% Confidence Interval | percentage of Participants | 28-42 days after vaccination |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The Outcome Measure was only pre-specified for the BK1301 Arm/Group. | Posted | Number | 95% Confidence Interval | percentage of Participants | 28-42 days after vaccination |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Titers (GMTs) of Anti-D and Anti-T Antibodies | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | 28-42 days after vaccination |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Titers (GMTs) of Anti-PT and Anti-FHA Antibodies | The Outcome Measure was only pre-specified for the BK1301 Arm/Group. | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | 28-42 days after vaccination |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Posted | Geometric Mean | 95% Confidence Interval | titer ratio | pre vaccination and 28-42 days after vaccination |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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 | The Outcome Measure was only pre-specified for the BK1301 Arm/Group. | Posted | Geometric Mean | 95% Confidence Interval | titer ratio | pre vaccination and 28-42 days after vaccination |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events | Posted | Number | percentage of participants | 28-42 days following vaccination |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BK1301 | Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection | 0 | 223 | 200 | 223 | ||
| EG001 | DT Toxoid | Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection | 0 | 222 | 194 | 222 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | MedDRA 17 |
| ||
| Injection site induration | General disorders | MedDRA 17 |
| ||
| Injection site pain | General disorders | MedDRA 17 |
| ||
| Injection site pruritus | General disorders | MedDRA 17 |
| ||
| Injection site swelling | General disorders | MedDRA 17 |
| ||
| Injection site warmth | General disorders | MedDRA 17 |
| ||
| Pyrexia | General disorders | MedDRA 17 |
| ||
| Nasopharyngitis | Infections and infestations | MedDRA 17 |
| ||
| Headache | Nervous system disorders | MedDRA 17 |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials, Information Desk / Clinical Development counter | Tanabe Pharma Corporation / The Research Foundation for Microbial Diseases of Osaka University | cti-inq-ml.JP@ml.tanabe-pharma.com/clinicaldevelopment@mail.biken.or.jp |
| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D013742 | Tetanus |
| D014917 | Whooping Cough |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003015 | Clostridium Infections |
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D013745 | Tetanus Toxoid |
| D022681 | Diphtheria-Tetanus-acellular Pertussis Vaccines |
| ID | Term |
|---|---|
| D014121 | Toxoids |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D010567 | Pertussis Vaccine |
| D001428 | Bacterial Vaccines |
| D004168 | Diphtheria Toxoid |
| D017778 | Vaccines, Combined |
| D022282 | Vaccines, Acellular |
| D022223 | Vaccines, Subunit |
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| >=65 years |
|
| Male |
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| anti-PT |
| |||||
| anti-FHA |
|
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
| anti-PT |
| |||||
| anti-FHA |
|
|
|
|