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The purpose of this study is to evaluate efficacy and safety of MT-2301 when co-administered with DPT-IPV using ActHIB® as a control in healthy infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT-2301-Low | Experimental |
| |
| MT-2301-High | Experimental |
| |
| ActHIB | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate)-Low + DPT-IPV | Biological | 0.25mL, subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | 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 |
|---|---|---|
| Takashi Nakano, M.D., Ph.D. | Department of pediatrics, Kawasaki Hospital, Kawasaki Medical School | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational site | Fukuoka | Fukuoka | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | MT-2301-Low | Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-Low |
| FG001 | MT-2301-High | Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-High |
| FG002 | ActHIB | Haemophilus influenza type b conjugate vaccine |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MT-2301-Low | Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-Low |
| BG001 | MT-2301-High | Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-High |
| 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, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | For antibody analysis at Visit 4, number of subjects 154. | 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 | MT-2301-Low | Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-Low |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA/J version 18. | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye discharge | Eye disorders | MedDRA/J version 18. | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials, Information Desk | Tanabe Pharma Corporation | +81-120-753-280 | cti-inq-ml.JP@ml.tanabe-pharma.com |
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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 |
|---|---|
| C055753 | Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate |
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| Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate)-High + DPT-IPV | Biological | 0.5mL, subcutaneous injection |
|
|
| Haemophilus influenza type b conjugate vaccine + DPT-IPV | Biological | 0.5mL, subcutaneous injection |
|
|
| 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) |
| Fold Change in Geometric Mean Antibody Titer Against Polio Virus | 4 weeks after the primary immunization (Visit 4) |
| 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 | 4 weeks after the booster dose (Visit 6) |
| BG002 | ActHIB | Haemophilus influenza type b conjugate vaccine |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Haemophilus influenza type b conjugate vaccine |
|
|
| 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 154. | 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 154. | 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 | For antibody analysis at Visit 6, number of subjects decreased from 154 to 152.MT-2301-Low group: due to withdrawal by parent/guardian (n=1) . MT-2301-High 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 6, number of subjects decreased from 154 to 152.MT-2301-Low group: due to withdrawal by parent/guardian (n=1) . MT-2301-High 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 6, number of subjects decreased from 154 to 152.MT-2301-Low group: due to withdrawal by parent/guardian (n=1) . MT-2301-High 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 154. MT-2301-High group number of subjects further decreased due to insufficient sample volume (diphtheria :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 154. | Posted | Geometric Mean | 95% Confidence Interval | U/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 154. | Posted | Geometric Mean | 95% Confidence Interval | U/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 154. MT-2301-High group number of subjects further decreased due to insufficient sample volume (polio serotype1,2 and 3: n=3 each) . MT-2301-Low group number of subjects further decreased due to insufficient sample volume (polio serotype1,2 and 3: n=2 each). ActHIV 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 | 4 weeks after the primary immunization (Visit 4) |
|
|
|
| Secondary | Geometric Mean Antibody Titer Against Diphtheria Toxin | For antibody analysis at Visit 6, number of subjects 152. | 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 6, number of subjects 152. | Posted | Geometric Mean | 95% Confidence Interval | U/mL | 4 weeks after the booster dose (Visit 6) |
|
|
|
| Secondary | Geometric Mean Antibody Titer Against Tetanus Toxin | For antibody analysis at Visit 6, number of subjects 152. | Posted | Geometric Mean | 95% Confidence Interval | U/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 6, number of subjects 152. MT-2301-High group number of subjects further decreased due to insufficient sample volume (polio serotype1: n=1) . ActHIV 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 | 4 weeks after the booster dose (Visit 6) |
|
|
|
| 0 |
| 52 |
| 4 |
| 52 |
| 52 |
| 52 |
| EG001 | MT-2301-High | Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-High | 0 | 52 | 2 | 52 | 52 | 52 |
| EG002 | ActHIB | Haemophilus influenza type b conjugate vaccine | 0 | 50 | 2 | 50 | 49 | 50 |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA/J version 18. | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA/J version 18. | Systematic Assessment |
|
| Food allergy | Immune system disorders | MedDRA/J version 18. | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA/J version 18. | Systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA/J version 18. | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA/J version 18. | Systematic Assessment |
|
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA/J version 18. | Systematic Assessment |
|
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA/J version 18. | Systematic Assessment |
|
| Febrile convulsion | Nervous system disorders | MedDRA/J version 18. | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA/J version 18. | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA/J version 18. | Systematic Assessment |
|
| Crying | General disorders | MedDRA/J version 18. | Systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA/J version 18. | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA/J version 18. | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA/J version 18. | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA/J version 18. | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA/J version 18. | Systematic Assessment |
|
| Irritability postvaccinal | General disorders | MedDRA/J version 18. | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA/J version 18. | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA/J version 18. | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA/J version 18. | Systematic Assessment |
|
| Exanthema subitum | Infections and infestations | MedDRA/J version 18. | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA/J version 18. | Systematic Assessment |
|
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA/J version 18. | Systematic Assessment |
|
| Herpangina | Infections and infestations | MedDRA/J version 18. | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA/J version 18. | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA/J version 18. | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA/J version 18. | Systematic Assessment |
|
| Respiratory syncytial virus infection | Infections and infestations | MedDRA/J version 18. | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA/J version 18. | Systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA/J version 18. | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA/J version 18. | Systematic Assessment |
|
| Hypersomnia | Nervous system disorders | MedDRA/J version 18. | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA/J version 18. | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA/J version 18. | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA/J version 18. | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA/J version 18. | Systematic Assessment |
|
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA/J version 18. | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA/J version 18. | Systematic Assessment |
|
| Eczema infantile | Skin and subcutaneous tissue disorders | MedDRA/J version 18. | Systematic Assessment |
|
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA/J version 18. | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA/J version 18. | Systematic Assessment |
|
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| D007239 | Infections |
| pertussis （FHA） |
|
| polio virus serotype 2 |
|
| polio virus serotype 3 |
|
| pertussis （FHA） |
|
| polio virus serotype 2 |
|
|
| polio virus serotype 3 |
|
|