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| Name | Class |
|---|---|
| The Research Foundation for Microbial Diseases of Osaka University | OTHER |
Not provided
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The purpose of this study is to:
<Cohort 1>
<Cohort 2>
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: BK1310-High | Experimental |
| |
| Cohort 1: BK1310-Low | Experimental |
| |
| Cohort 2: BK1310-High or -Low | Experimental | Either BK1310-High or -Low will be chosen based on the result of cohort 1 |
|
| Cohort 2: ActHIB® and Tetrabik | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DPT-IPV-Hib-High（Combined Vaccine） | Biological |
|
|
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| General Manager | Tanabe Pharma Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fukuoka | Fukuoka | Japan | ||||
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | BK1310-High | (Cohort 1) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months. |
| FG001 | BK1310-Low | (Cohort 1) DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months. |
| FG002 | BK1310 | (Cohort 2) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals. |
| FG003 | ActHIB® and Tetrabik (Control) | (Cohort 2) Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cohort 1 |
| |||||||||||||
| Cohort 2 |
|
【cohort 2_Age,Sex/Gender】 Excluding 5 subjects(BK1310: 1 subject, control: 4 subjects) whose all antibody titers could not be measured at Visit 4
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BK1310-High | (Cohort 1) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months. |
| BG001 | BK1310-Low |
| 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 370 to 365. BK1310 group: due to physician decision (n=1).Control group: due to withdrawal by parent/guardian (n=2) and deviation in blood collection timing (n=2). In control group number of subjects further decreased due to insufficient sample volume (diphtheria: n=2, PT: n=1, FHA: n=1, tetanus: n=1, polio serotype1: n=5, polio serotype2: n=4, polio serotype3: n=4） | Posted | Number | 95% Confidence Interval | percentage of participants | 4 weeks after the primary immunization (Visit 4) |
|
Through study completion, an average of 1 year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BK1310-High | (Cohort 1) DPT-IPV-Hib-High(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 |
|---|---|---|---|---|---|
| Anaphylactic reaction | Immune system disorders | MedDRA/J Version 19. | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye discharge | Eye disorders | MedDRA/J Version 19. | Systematic Assessment |
Not provided
| 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 |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 15, 2017 | Mar 22, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 10, 2018 | Mar 22, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D007239 | Infections |
| D006192 | Haemophilus Infections |
| ID | Term |
|---|---|
| D016871 | Pasteurellaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
Not provided
Not provided
| ID | Term |
|---|---|
| C061963 | HibTITER protein, Haemophilus influenzae |
| C055753 | Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| DPT-IPV-Hib-Low（Combined Vaccine） | Biological |
|
|
| Hib vaccine | Biological |
|
|
| DPT-IPV | Biological |
|
|
| 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) |
| Kasuga-shi |
| Fukuoka |
| Japan |
| Sendai | Miyagi | Japan |
| COMPLETED |
|
| NOT COMPLETED |
|
|
(Cohort 1) DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
| BG002 | BK1310 | (Cohort 2) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals. |
| BG003 | ActHIB® and Tetrabik (Control) | (Cohort 2) Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | BK1310-High | (Cohort 1) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months. |
| OG001 | BK1310-Low | (Cohort 1) DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months. |
| OG002 | BK1310 | (Cohort 2) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals. |
| OG003 | ActHIB® and Tetrabik (Control) | (Cohort 2) Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals. |
|
|
| 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 370 to 365. BK1310 group: due to physician decision (n=1).Control group: due to withdrawal by parent/guardian (n=2) and deviation in blood collection timing (n=2). | 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 | For antibody analysis at Visit 4, number of subjects decreased from 370 to 365. BK1310 group: due to physician decision (n=1).Control group: due to withdrawal by parent/guardian (n=2) and deviation in blood collection timing (n=2). | 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 | Only subjects in cohort 1 were analyzed. Visit 6 was not conducted in Cohort 2（Arm；BK-1310，ActHIB® and Tetrabik）, and the data of Cohort 2 were not collected. Therefore, no data of Cohort 2 are available. | 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 | Only subjects in cohort 1 were analyzed. Visit 6 was not conducted in Cohort 2（Arm；BK-1310，ActHIB® and Tetrabik）, and the data of Cohort 2 were not collected. Therefore, no data of Cohort 2 are available. | 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 | Only subjects in cohort 1 were analyzed. Visit 6 was not conducted in Cohort 2（Arm；BK-1310，ActHIB® and Tetrabik）, and the data of Cohort 2 were not collected. Therefore, no data of Cohort 2 are available. | 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 370 to 365. BK1310 group: due to physician decision (n=1).Control group: due to withdrawal by parent/guardian (n=2) and deviation in blood collection timing (n=2). In control group number of subjects further decreased due to insufficient sample volume (diphtheria: n=2） | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | 4 weeks after the primary immunization (Visit 4) |
|
|
|
| Secondary | Geometric Mean Antibody Titer Against Pertussis （PT） | For antibody analysis at Visit 4, number of subjects decreased from 370 to 365. BK1310 group: due to physician decision (n=1).Control group: due to withdrawal by parent/guardian (n=2) and deviation in blood collection timing (n=2). In control group number of subjects further decreased due to insufficient sample volume (PT: n=1） | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | 4 weeks after the primary immunization (Visit 4) |
|
|
|
| Secondary | Geometric Mean Antibody Titer Against Pertussis （FHA） | For antibody analysis at Visit 4, number of subjects decreased from 370 to 365. BK1310 group: due to physician decision (n=1).Control group: due to withdrawal by parent/guardian (n=2) and deviation in blood collection timing (n=2). In control group number of subjects further decreased due to insufficient sample volume (FHA: 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 370 to 365. BK1310 group: due to physician decision (n=1).Control group: due to withdrawal by parent/guardian (n=2) and deviation in blood collection timing (n=2). In control group number of subjects further decreased due to insufficient sample volume (tetanus: n=1） | 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 | For antibody analysis at Visit 4, number of subjects decreased from 370 to 361. BK1310 group: due to physician decision (n=1). Control group: due to withdrawal by parent/guardian (n=2), deviation in blood collection timing (n=2), insufficient sample volume (n=4). In control group number of subjects further decreased due to insufficient sample volume (polio serotype1: n=1） | 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 | Only subjects in cohort 1 were analyzed. Visit 6 was not conducted in Cohort 2（Arm；BK-1310，ActHIB® and Tetrabik）, and the data of Cohort 2 were not collected. Therefore, no data of Cohort 2 are available. | Posted | Number | 95% Confidence Interval | percentage of participants | 4 weeks after the booster dose (Visit 6) |
|
|
|
| Secondary | Geometric Mean Antibody Titer Against Diphtheria Toxin | Only subjects in cohort 1 were analyzed. Visit 6 was not conducted in Cohort 2（Arm；BK-1310，ActHIB® and Tetrabik）, and the data of Cohort 2 were not collected. Therefore, no data of Cohort 2 are available. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | 4 weeks after the booster dose (Visit 6) |
|
|
|
| Secondary | Geometric Mean Antibody Titer Against Pertussis （PT） | Only subjects in cohort 1 were analyzed. Visit 6 was not conducted in Cohort 2（Arm；BK-1310，ActHIB® and Tetrabik）, and the data of Cohort 2 were not collected. Therefore, no data of Cohort 2 are available. | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | 4 weeks after the booster dose (Visit 6) |
|
|
|
| Secondary | Geometric Mean Antibody Titer Against Pertussis （FHA） | Only subjects in cohort 1 were analyzed. Visit 6 was not conducted in Cohort 2（Arm；BK-1310，ActHIB® and Tetrabik）, and the data of Cohort 2 were not collected. Therefore, no data of Cohort 2 are available. | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | 4 weeks after the booster dose (Visit 6) |
|
|
|
| Secondary | Geometric Mean Antibody Titer Against Tetanus Toxin | Only subjects in cohort 1 were analyzed. Visit 6 was not conducted in Cohort 2（Arm；BK-1310，ActHIB® and Tetrabik）, and the data of Cohort 2 were not collected. Therefore, no data of Cohort 2 are available. | 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 | Only subjects in cohort 1 were analyzed. Visit 6 was not conducted in Cohort 2（Arm；BK-1310，ActHIB® and Tetrabik）, and the data of Cohort 2 were not collected. Therefore, no data of Cohort 2 are available. | Posted | Geometric Mean | 95% Confidence Interval | fold change | Baseline and 4 weeks after the primary immunization (Visit 6) |
|
|
|
| 0 |
| 15 |
| 1 |
| 15 |
| 15 |
| 15 |
| EG001 | BK1310-Low | (Cohort 1) DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months. | 0 | 15 | 0 | 15 | 15 | 15 |
| EG002 | BK1310 | (Cohort 2) DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals. | 0 | 171 | 8 | 171 | 162 | 171 |
| EG003 | ActHIB® and Tetrabik (Control) | (Cohort 2) Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals. | 0 | 169 | 5 | 169 | 163 | 169 |
| Adenovirus infection | Infections and infestations | MedDRA/J Version 19. | Systematic Assessment |
|
| Bronchitis bacterial | Infections and infestations | MedDRA/J Version 19. | Systematic Assessment |
|
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA/J Version 19. | Systematic Assessment |
|
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA/J Version 19. | Systematic Assessment |
|
| Respiratory syncytial virus bronchitis | Infections and infestations | MedDRA/J Version 19. | Systematic Assessment |
|
| Respiratory syncytial virus infection | Infections and infestations | MedDRA/J Version 19. | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA/J Version 19. | Systematic Assessment |
|
| Infantile haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J Version 19. | Systematic Assessment |
|
| Kawasaki's disease | Vascular disorders | MedDRA/J Version 19. | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA/J Version 19. | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA/J Version 19. | Systematic Assessment |
|
| Faeces soft | Gastrointestinal disorders | MedDRA/J Version 19. | Systematic Assessment |
|
| Crying | General disorders | MedDRA/J Version 19. | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA/J Version 19. | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA/J Version 19. | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA/J Version 19. | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA/J Version 19. | Systematic Assessment |
|
| Irritability postvaccinal | General disorders | MedDRA/J Version 19. | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA/J Version 19. | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA/J Version 19. | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA/J Version 19. | Systematic Assessment |
|
| Dermatitis infected | Infections and infestations | MedDRA/J Version 19. | Systematic Assessment |
|
| Exanthema subitum | Infections and infestations | MedDRA/J Version 19. | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA/J Version 19. | Systematic Assessment |
|
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA/J Version 19. | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA/J Version 19. | Systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA/J Version 19. | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA/J Version 19. | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA/J Version 19. | Systematic Assessment |
|
| Otitis media acute | Infections and infestations | MedDRA/J Version 19. | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA/J Version 19. | Systematic Assessment |
|
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA/J Version 19. | Systematic Assessment |
|
| Respiratory syncytial virus infection | Infections and infestations | MedDRA/J Version 19. | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA/J Version 19. | Systematic Assessment |
|
| Viral rash | Infections and infestations | MedDRA/J Version 19. | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA/J Version 19. | Systematic Assessment |
|
| Hypersomnia | Nervous system disorders | MedDRA/J Version 19. | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA/J Version 19. | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA/J Version 19. | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA/J Version 19. | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA/J Version 19. | Systematic Assessment |
|
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA/J Version 19. | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA/J Version 19. | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA/J Version 19. | Systematic Assessment |
|
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA/J Version 19. | Systematic Assessment |
|
| Eczema infantile | Skin and subcutaneous tissue disorders | MedDRA/J Version 19. | Systematic Assessment |
|
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA/J Version 19. | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA/J Version 19. | Systematic Assessment |
|
Not provided
|
|
|
|
|
|
|
|
| Geometric mean antibody titer against polio virus serotype 2 |
|
|
| Geometric mean antibody titer against polio virus serotype 3 |
|
|
| 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 |
|