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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2080224611 | Registry Identifier | Japan Registry of Clinical Trials (jRCT) |
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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 immunogenicity of BK1310 for all antigens (anti-PRP, diphtheria toxin, pertussis, tetanus toxin, and polio virus), after 3 times of injection, when compared noninferiority with co-administration of ActHIB® and Tetrabik, as well as efficacy and safety, in healthy infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BK1310 | Experimental |
| |
| ActHIB® and Tetrabik | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DPT-IPV-Hib | Biological | 0.5mL, subcutaneous 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 | 4weeks after the primary immunization (Visit 4) | |
| Geometric Mean Antibody Titer of Anti-PRP Antibody | 4weeks after the primary immunization (Visit 4) |
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Inclusion Criteria:
Exclusion Criteria:
Additional screening criteria check may apply for qualification.
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| Name | Affiliation | Role |
|---|---|---|
| General Manager | Tanabe Pharma Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Fukuoka | Fukuoka | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38582691 | Result | Nakano T, Hasegawa M, Endo M, Matsuda K, Tamai H. Immunogenicity and safety of adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain)-Haemophilus type b conjugate combined vaccine (DPT-IPV-Hib) in healthy Japanese Infants >/= 2 and < 43 months of Age: A phase III, multicenter, active controlled, assessor-blinded, randomized, parallel-group study. Vaccine. 2024 Apr 30;42(12):3134-3143. doi: 10.1016/j.vaccine.2023.03.077. Epub 2024 Apr 6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | BK1310 | DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months. |
| FG001 | ActHIB® and Tetrabik (Control) | Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Excluding 1 subject(control: 1 subject) whose all antibody titers could not be measured at Visit 4
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| ID | Title | Description |
|---|---|---|
| BG000 | BK1310 | DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months. |
| BG001 | ActHIB® and Tetrabik (Control) |
| 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 | For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) . In BK1310 group number of subjects further decreased due to insufficient sample volume (polio serotype1,2 and 3: n=2 each). In control group number of subjects further decreased due to insufficient sample volume (polio serotype1,2 and 3: n=1 each). | 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, subcutaneous 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 |
|---|---|---|---|---|---|
| Cholangiectasis congenital | Congenital, familial and genetic disorders | MedDRA version 21.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Crying | General disorders | MedDRA version 21.1 | 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 | Dec 19, 2018 | Mar 22, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 10, 2020 | Mar 22, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D013742 | Tetanus |
| D004165 | Diphtheria |
| D014917 | Whooping Cough |
| D011051 | Poliomyelitis |
| D016920 | Meningitis, Bacterial |
| D006192 | Haemophilus Infections |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C061963 | HibTITER protein, Haemophilus influenzae |
| C055753 | Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate |
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| Hib vaccine | Biological | 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months. |
|
|
| DPT-IPV | Biological | 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months. |
|
|
| 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 | 4 weeks after the primary immunization (Visit 4) |
| Geometric Mean Antibody Titer Against Tetanus Toxin | 4 weeks after the primary immunization (Visit 4) |
| Geometric Mean Antibody Titer Against Polio Virus | 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 | 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) |
Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG000 | BK1310 | DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months. |
| OG001 | ActHIB® and Tetrabik (Control) | Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months. |
|
|
| Secondary | Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody | For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) . | Posted | Number | 95% Confidence Interval | percentage of participants | 4weeks after the primary immunization (Visit 4) |
|
|
|
| Secondary | Geometric Mean Antibody Titer of Anti-PRP Antibody | For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) . | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | 4weeks 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 | For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) . For antibody analysis at Visit 6, number of subjects decreased from 266 to 264. BK1310 group: due to Adverse event (n=2, onty 1 patient was able to collect a sample at discontinuation. The data at this time point was included in Visit 6). Control group: due to withdrawal by parent/guardian (n=1) . | 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 | For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) . For antibody analysis at Visit 6, number of subjects decreased from 266 to 264. BK1310 group: due to Adverse event (n=2, onty 1 patient was able to collect a sample at discontinuation. The data at this time point was included in Visit 6). Control group: due to withdrawal by parent/guardian (n=1) . | 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 | For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) . For antibody analysis at Visit 6, number of subjects decreased from 266 to 264. BK1310 group: due to Adverse event (n=2, onty 1 patient was able to collect a sample at discontinuation. The data at this time point was included in Visit 6). Control group: due to withdrawal by parent/guardian (n=1) . | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | 4 weeks after the booster dose (Visit 6) |
|
|
|
| Secondary | Geometric Mean Antibody Titer Against Diphtheria Toxin | For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) . | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | 4 weeks after the primary immunization (Visit 4) |
|
|
|
| Secondary | Geometric Mean Antibody Titer Against Pertussis | For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) . | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | 4 weeks after the primary immunization (Visit 4) |
|
|
|
| Secondary | Geometric Mean Antibody Titer Against Tetanus Toxin | For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) . | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | 4 weeks after the primary immunization (Visit 4) |
|
|
|
| Secondary | Geometric Mean Antibody Titer Against Polio Virus | For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) . In BK1310 group number of subjects further decreased due to insufficient sample volume (polio serotype1,2 and 3: n=2 each). In control group number of subjects further decreased due to insufficient sample volume (polio serotype1,2 and 3: n=1 each). | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | 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 | For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1). For antibody analysis at Visit 6, number of subjects decreased from 266 to 264. BK1310 group: due to Adverse event (n=2). Control group: due to withdrawal by parent/guardian (n=1) .In BK1310 group number of subjects further decreased due to insufficient sample volume (tetanus: n=1, polio serotype1,2 and 3: n=1 each). | Posted | Number | 95% Confidence Interval | percentage of participants | 4 weeks after the booster dose (Visit 6) |
|
|
|
| Secondary | Geometric Mean Antibody Titer Against Diphtheria Toxin | For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) . For antibody analysis at Visit 6, number of subjects decreased from 266 to 264. BK1310 group: due to Adverse event (n=2, onty 1 patient was able to collect a sample at discontinuation. The data at this time point was included in Visit 6). Control group: due to withdrawal by parent/guardian (n=1) . | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | 4 weeks after the booster dose (Visit 6) |
|
|
|
| Secondary | Geometric Mean Antibody Titer Against Pertussis | For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) . For antibody analysis at Visit 6, number of subjects decreased from 266 to 264. BK1310 group: due to Adverse event (n=2, onty 1 patient was able to collect a sample at discontinuation. The data at this time point was included in Visit 6). Control group: due to withdrawal by parent/guardian (n=1) . | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | 4 weeks after the booster dose (Visit 6) |
|
|
|
| Secondary | Geometric Mean Antibody Titer Against Tetanus Toxin | For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) . For antibody analysis at Visit 6, number of subjects decreased from 266 to 264. BK1310 group: due to Adverse event (n=2). Control group: due to withdrawal by parent/guardian (n=1) .In BK1310 group number of subjects further decreased due to insufficient sample volume (n=1). | 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 | For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) . For antibody analysis at Visit 6, number of subjects decreased from 266 to 264. BK1310 group: due to Adverse event (n=2). Control group: due to withdrawal by parent/guardian (n=1) .In BK1310 group number of subjects further decreased due to insufficient sample volume (polio serotype1,2 and 3: n=1 each). | Posted | Geometric Mean | 95% Confidence Interval | fold change | Baseline and 4 weeks after the primary immunization (Visit 6) |
|
|
|
| 0 |
| 133 |
| 9 |
| 133 |
| 131 |
| 133 |
| EG001 | ActHIB® and Tetrabik (Control) | Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months. | 0 | 134 | 11 | 134 | 132 | 134 |
| Adenovirus infection | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
|
| Enterocolitis bacterial | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
|
| Gastroenteritis norovirus | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
|
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
|
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
|
| Respiratory syncytial virus infection | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
|
| Fractured skull depressed | Injury, poisoning and procedural complications | MedDRA version 21.1 | Systematic Assessment |
|
| Febrile convulsion | Nervous system disorders | MedDRA version 21.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.1 | Systematic Assessment |
|
| Kawasaki's disease | Vascular disorders | MedDRA version 21.1 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA version 21.1 | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA version 21.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA version 21.1 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA version 21.1 | Systematic Assessment |
|
| Irritability postvaccinal | General disorders | MedDRA version 21.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA version 21.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 21.1 | Systematic Assessment |
|
| Hypersomnia | Nervous system disorders | MedDRA version 21.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA version 21.1 | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.1 | Systematic Assessment |
|
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA version 21.1 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA version 21.1 | Systematic Assessment |
|
| Eczema infantile | Skin and subcutaneous tissue disorders | MedDRA version 21.1 | Systematic Assessment |
|
Not provided
| D007239 | Infections |
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
| D020806 | Central Nervous System Bacterial Infections |
| D008581 | Meningitis |
| D016871 | Pasteurellaceae Infections |
| polio virus serotype 3 |
|
| Antibody prevalence rate against pertussis （PT） |
|
|
| Antibody prevalence rate against pertussis （FHA） |
|
|
| 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 |
|
|
| Geometric mean antibody titer against polio virus serotype 3 |
|