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| Name | Class |
|---|---|
| The Research Foundation for Microbial Diseases of Osaka University | OTHER |
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The purpose of this study is to evaluate the safety and efficacy of an intramuscular injection of BK1310 in healthy infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BK1310 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DPT-IPV-Hib (Combined Vaccine) | Biological | 0.5mL, intramuscular injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate is defined as the percentage of participants whose criteria of each antibody titer: Anti-diphtheria antibody concentrations: >=0.1 IU/mL, Anti-PT antibody concentrations: >=10.0 EU/mL, Anti-FHA antibody concentrations: >=10.0 EU/mL, Anti-tetanus antibody concentrations: >=0.01 IU/mL, Anti-poliovirus serotype 1,2 and 3 antibody titers (fold) >=8 | 4 weeks after the primary immunization (Visit 4) |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody | 4 weeks after the primary immunization (Visit 4) | |
| Geometric Mean Antibody Titer of Anti-PRP Antibody | 4 weeks after the primary immunization (Visit 4) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| General Manager | Tanabe Pharma Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational site 1 | Chiba | Japan | ||||
| Investigational site 2 |
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| ID | Title | Description |
|---|---|---|
| FG000 | BK1310 | DPT-IPV-Hib (Combined Vaccine): 0.5mL, intramuscular injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BK1310 | DPT-IPV-Hib (Combined Vaccine): 0.5mL, intramuscular injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of 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 | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | Antibody prevalence rate is defined as the percentage of participants whose criteria of each antibody titer: Anti-diphtheria antibody concentrations: >=0.1 IU/mL, Anti-PT antibody concentrations: >=10.0 EU/mL, Anti-FHA antibody concentrations: >=10.0 EU/mL, Anti-tetanus antibody concentrations: >=0.01 IU/mL, Anti-poliovirus serotype 1,2 and 3 antibody titers (fold) >=8 | Posted | Number | 95% Confidence Interval | percentage of participants | 4 weeks after the primary immunization (Visit 4) |
|
Through study completion, an average of 1 year
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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 | BK1310 | DPT-IPV-Hib (Combined Vaccine): 0.5mL, intramuscular injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchiolitis | Infections and infestations | MedDRA/J Version 20. | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA/J Version 20. | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials, Information Desk | Tanabe Pharma Corporation / The Research Foundation for Microbial Diseases of Osaka University | Please email | cti-inq-ml.JP@ml.tanabe-pharma.com, clinicaldevelopment@mail.biken.or.jp |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 24, 2017 | Mar 22, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 9, 2018 | Mar 22, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006192 | Haemophilus Infections |
| ID | Term |
|---|---|
| D016871 | Pasteurellaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| ID | Term |
|---|---|
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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|
| Anti-PRP Antibody Prevalence Rate With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody | 4 weeks after the booster dose (Visit 6) |
| Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody | 4 weeks after the booster dose (Visit 6) |
| Geometric Mean Antibody Titer of Anti-PRP Antibody | 4 weeks after the booster dose (Visit 6) |
| Geometric Mean Antibody Titer Against Diphtheria Toxin | 4 weeks after the primary immunization (Visit 4) |
| Geometric Mean Antibody Titer Against Pertussis （PT） | 4 weeks after the primary immunization (Visit 4) |
| Geometric Mean Antibody Titer Against Pertussis （FHA） | 4 weeks after the primary immunization (Visit 4) |
| Geometric Mean Antibody Titer Against Tetanus Toxin | 4 weeks after the primary immunization (Visit 4) |
| Fold Change in Geometric Mean Antibody Titer Against Polio Virus | Baseline and 4 weeks after the primary immunization (Visit 4) |
| Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus | Antibody prevalence rate is defined as the percentage of participants whose criteria of each antibody titer: Anti-diphtheria antibody concentrations: >=0.1 IU/mL, Anti-PT antibody concentrations: >=10.0 EU/mL, Anti-FHA antibody concentrations: >=10.0 EU/mL, Anti-tetanus antibody concentrations: >=0.01 IU/mL, Anti-poliovirus serotype 1,2 and 3 antibody titers (fold) >=8 | 4 weeks after the booster dose (Visit 6) |
| Geometric Mean Antibody Titer Against Diphtheria Toxin | 4 weeks after the booster dose (Visit 6) |
| Geometric Mean Antibody Titer Against Pertussis （PT） | 4 weeks after the booster dose (Visit 6) |
| Geometric Mean Antibody Titer Against Pertussis （FHA） | 4 weeks after the booster dose (Visit 6) |
| Geometric Mean Antibody Titer Against Tetanus Toxin | 4 weeks after the booster dose (Visit 6) |
| Fold Change in Geometric Mean Antibody Titer Against Polio Virus | Baseline and 4 weeks after the primary immunization (Visit 6) |
| Tokyo |
| Japan |
| Investigational site 3 | Tokyo | Japan |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody | Posted | Number | 95% Confidence Interval | percentage of participants | 4 weeks after the primary immunization (Visit 4) |
|
|
|
| Secondary | Geometric Mean Antibody Titer of Anti-PRP Antibody | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | 4 weeks after the primary immunization (Visit 4) |
|
|
|
| Secondary | Anti-PRP Antibody Prevalence Rate With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody | Posted | Number | 95% Confidence Interval | percentage of participants | 4 weeks after the booster dose (Visit 6) |
|
|
|
| Secondary | Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody | Posted | Number | 95% Confidence Interval | percentage of participants | 4 weeks after the booster dose (Visit 6) |
|
|
|
| Secondary | Geometric Mean Antibody Titer of Anti-PRP Antibody | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | 4 weeks after the booster dose (Visit 6) |
|
|
|
| Secondary | Geometric Mean Antibody Titer Against Diphtheria Toxin | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | 4 weeks after the primary immunization (Visit 4) |
|
|
|
| Secondary | Geometric Mean Antibody Titer Against Pertussis （PT） | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | 4 weeks after the primary immunization (Visit 4) |
|
|
|
| Secondary | Geometric Mean Antibody Titer Against Pertussis （FHA） | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | 4 weeks after the primary immunization (Visit 4) |
|
|
|
| Secondary | Geometric Mean Antibody Titer Against Tetanus Toxin | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | 4 weeks after the primary immunization (Visit 4) |
|
|
|
| Secondary | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | Posted | Geometric Mean | 95% Confidence Interval | fold change | Baseline and 4 weeks after the primary immunization (Visit 4) |
|
|
|
| Secondary | Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus | Antibody prevalence rate is defined as the percentage of participants whose criteria of each antibody titer: Anti-diphtheria antibody concentrations: >=0.1 IU/mL, Anti-PT antibody concentrations: >=10.0 EU/mL, Anti-FHA antibody concentrations: >=10.0 EU/mL, Anti-tetanus antibody concentrations: >=0.01 IU/mL, Anti-poliovirus serotype 1,2 and 3 antibody titers (fold) >=8 | Posted | Number | 95% Confidence Interval | percentage of participants | 4 weeks after the booster dose (Visit 6) |
|
|
|
| Secondary | Geometric Mean Antibody Titer Against Diphtheria Toxin | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | 4 weeks after the booster dose (Visit 6) |
|
|
|
| Secondary | Geometric Mean Antibody Titer Against Pertussis （PT） | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | 4 weeks after the booster dose (Visit 6) |
|
|
|
| Secondary | Geometric Mean Antibody Titer Against Pertussis （FHA） | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | 4 weeks after the booster dose (Visit 6) |
|
|
|
| Secondary | Geometric Mean Antibody Titer Against Tetanus Toxin | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | 4 weeks after the booster dose (Visit 6) |
|
|
|
| Secondary | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | Posted | Geometric Mean | 95% Confidence Interval | fold change | Baseline and 4 weeks after the primary immunization (Visit 6) |
|
|
|
| 0 |
| 33 |
| 2 |
| 33 |
| 33 |
| 33 |
| Bronchitis | Infections and infestations | MedDRA/J Version 20. | Systematic Assessment |
|
| Exanthema subitum | Infections and infestations | MedDRA/J Version 20. | Systematic Assessment |
|
| Crying | General disorders | MedDRA/J Version 20. | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA/J Version 20. | Systematic Assessment |
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| Injection site induration | General disorders | MedDRA/J Version 20. | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA/J Version 20. | Systematic Assessment |
|
| Irritability postvaccinal | General disorders | MedDRA/J Version 20. | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA/J Version 20. | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA/J Version 20. | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA/J Version 20. | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA/J Version 20. | Systematic Assessment |
|
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA/J Version 20. | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA/J Version 20. | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA/J Version 20. | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA/J Version 20. | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA/J Version 20. | Systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA/J Version 20. | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA/J Version 20. | Systematic Assessment |
|
| Hypersomnia | Nervous system disorders | MedDRA/J Version 20. | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA/J Version 20. | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA/J Version 20. | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA/J Version 20. | Systematic Assessment |
|
| Asteatosis | Skin and subcutaneous tissue disorders | MedDRA/J Version 20. | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA/J Version 20. | Systematic Assessment |
|
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA/J Version 20. | Systematic Assessment |
|
| Eczema infantile | Skin and subcutaneous tissue disorders | MedDRA/J Version 20. | Systematic Assessment |
|
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| D007239 | Infections |
| Title | Measurements |
|---|
|
|
| Antibody prevalence rate against tetanus toxin |
|
| Antibody prevalence rate against polio virus serotype 1 |
|
| Antibody prevalence rate against polio virus serotype 2 |
|
| Antibody prevalence rate against polio virus serotype 3 |
|
| Title | Measurements |
|---|
|