Haemophilus Influenza Type b
Conditions
Keywords
Haemophilus influenza type b, Hib
Brief summary
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.
Interventions
BIOLOGICALHaemophilus b conjugate vaccine diphteria CRM197 protein conjugate)-Low + DPT-IPV
0.25mL, subcutaneous injection
BIOLOGICALHaemophilus b conjugate vaccine diphteria CRM197 protein conjugate)-High + DPT-IPV
0.5mL, subcutaneous injection
BIOLOGICALHaemophilus influenza type b conjugate vaccine + DPT-IPV
0.5mL, subcutaneous injection
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Months to 7 Months
Healthy volunteers
Yes
Inclusion criteria
* Healthy infants aged ≥2 and \<7 months at the first vaccination of the study drug * Written informed consent is obtained from a legal guardian (parent)
Exclusion criteria
* With obvious pyrexia (axillary temperature of 37.5ºC or higher) at vaccination of the study drug * With known serious acute disease * With known underlying disease such as cardiovascular disease, renal disease, hepatic disease, blood dyscrasia, and respiratory disease * With past diagnosis of immunodeficiency or currently under immunosuppressive treatment * History of anaphylaxis due to food or pharmaceuticals * With experience of Hib infection, diphtheria, pertussis, tetanus, and acute poliomyelitis * With experience of Hib vaccination, or administration of vaccine including either diphtheria, pertussis, tetanus, or polio as a constituent * History of convulsions * Administered a live vaccine within 27 days before the first vaccination of the study drug, or inactivated vaccine or toxoid within 6 days before vaccination * Administered transfusion, immunosuppressant (excluding drugs for external use), or immunoglobulin formulation * Administered corticosteroid 2 mg/kg per day or more as prednisolone (excluding drugs for external use) continuously for more than 1 week * Participated in other studies within 12 weeks before obtaining consent
Design outcomes
Primary
| Measure | 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) |
Secondary
| Measure | 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) |
| 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) |
| 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) |
Countries
Japan
Contacts
STUDY_DIRECTORTakashi Nakano, M.D., Ph.D.
Department of pediatrics, Kawasaki Hospital, Kawasaki Medical School
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MT-2301-Low Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-Low | 52 |
| MT-2301-High Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate-High | 52 |
| ActHIB Haemophilus influenza type b conjugate vaccine | 50 |
| Total | 154 |
Baseline characteristics
| Characteristic | MT-2301-High | Total | ActHIB | MT-2301-Low |
|---|---|---|---|---|
| Age, Customized >=2 and <3 months | 39 Participants | 119 Participants | 37 Participants | 43 Participants |
| Age, Customized >=3 months | 13 Participants | 35 Participants | 13 Participants | 9 Participants |
| Race/Ethnicity, Customized Asian (Japanese) | 52 Participants | 154 Participants | 50 Participants | 52 Participants |
| Sex: Female, Male Female | 21 Participants | 64 Participants | 20 Participants | 23 Participants |
| Sex: Female, Male Male | 31 Participants | 90 Participants | 30 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 52 | 0 / 50 |
| other Total, other adverse events | 52 / 52 | 52 / 52 | 49 / 50 |
| serious Total, serious adverse events | 4 / 52 | 2 / 52 | 2 / 50 |
Outcome results
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
Time frame: 4 weeks after the primary immunization (Visit 4)
Population: For antibody analysis at Visit 4, number of subjects 154.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MT-2301-Low | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | 100.0 percentage of participants |
| MT-2301-High | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | 96.2 percentage of participants |
| ActHIB | Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Antibody Against Anti-PRP | 94.0 percentage of 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
Time frame: 4 weeks after the primary immunization (Visit 4)
Population: For antibody analysis at Visit 4, number of subjects 154.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MT-2301-Low | Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody | 100.0 percentage of participants |
| MT-2301-High | Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody | 100.0 percentage of participants |
| ActHIB | Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody | 100.0 percentage of 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
Time frame: 4 weeks after the booster dose (Visit 6)
Population: 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) .
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MT-2301-Low | Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody | 100.0 percentage of participants |
| MT-2301-High | Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody | 100.0 percentage of participants |
| ActHIB | Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody | 100.0 percentage of participants |
Secondary
Anti-PRP Antibody Prevalence Rate With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
Time frame: 4 weeks after the booster dose (Visit 6)
Population: 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) .
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MT-2301-Low | Anti-PRP Antibody Prevalence Rate With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody | 100.0 percentage of participants |
| MT-2301-High | Anti-PRP Antibody Prevalence Rate With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody | 100.0 percentage of participants |
| ActHIB | Anti-PRP Antibody Prevalence Rate With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody | 100.0 percentage of participants |
Secondary
Fold Change in Geometric Mean Antibody Titer Against Polio Virus
Time frame: 4 weeks after the primary immunization (Visit 4)
Population: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MT-2301-Low | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | polio virus serotype 2 | 2272.4 fold change |
| MT-2301-Low | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | polio virus serotype 3 | 2574.4 fold change |
| MT-2301-Low | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | polio virus serotype 1 | 1468.4 fold change |
| MT-2301-High | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | polio virus serotype 3 | 1976.8 fold change |
| MT-2301-High | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | polio virus serotype 1 | 1554.3 fold change |
| MT-2301-High | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | polio virus serotype 2 | 2776.0 fold change |
| ActHIB | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | polio virus serotype 2 | 2896.3 fold change |
| ActHIB | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | polio virus serotype 3 | 2198.1 fold change |
| ActHIB | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | polio virus serotype 1 | 1790.5 fold change |
Secondary
Fold Change in Geometric Mean Antibody Titer Against Polio Virus
Time frame: 4 weeks after the booster dose (Visit 6)
Population: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MT-2301-Low | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | polio virus serotype 2 | 8360.7 fold change |
| MT-2301-Low | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | polio virus serotype 1 | 3479.6 fold change |
| MT-2301-Low | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | polio virus serotype 3 | 6681.2 fold change |
| MT-2301-High | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | polio virus serotype 2 | 9908.9 fold change |
| MT-2301-High | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | polio virus serotype 1 | 4544.8 fold change |
| MT-2301-High | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | polio virus serotype 3 | 7448.6 fold change |
| ActHIB | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | polio virus serotype 1 | 4685.1 fold change |
| ActHIB | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | polio virus serotype 3 | 7578.8 fold change |
| ActHIB | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | polio virus serotype 2 | 10642.5 fold change |
Secondary
Geometric Mean Antibody Titer Against Diphtheria Toxin
Time frame: 4 weeks after the primary immunization (Visit 4)
Population: 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)
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| MT-2301-Low | Geometric Mean Antibody Titer Against Diphtheria Toxin | 1.026 IU/mL |
| MT-2301-High | Geometric Mean Antibody Titer Against Diphtheria Toxin | 1.016 IU/mL |
| ActHIB | Geometric Mean Antibody Titer Against Diphtheria Toxin | 1.110 IU/mL |
Secondary
Geometric Mean Antibody Titer Against Diphtheria Toxin
Time frame: 4 weeks after the booster dose (Visit 6)
Population: For antibody analysis at Visit 6, number of subjects 152.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| MT-2301-Low | Geometric Mean Antibody Titer Against Diphtheria Toxin | 9.831 IU/mL |
| MT-2301-High | Geometric Mean Antibody Titer Against Diphtheria Toxin | 10.102 IU/mL |
| ActHIB | Geometric Mean Antibody Titer Against Diphtheria Toxin | 9.511 IU/mL |
Secondary
Geometric Mean Antibody Titer Against Pertussis
Time frame: 4 weeks after the primary immunization (Visit 4)
Population: For antibody analysis at Visit 4, number of subjects 154.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MT-2301-Low | Geometric Mean Antibody Titer Against Pertussis | pertussis （PT） | 189.03 U/mL |
| MT-2301-Low | Geometric Mean Antibody Titer Against Pertussis | pertussis （FHA） | 54.82 U/mL |
| MT-2301-High | Geometric Mean Antibody Titer Against Pertussis | pertussis （PT） | 191.62 U/mL |
| MT-2301-High | Geometric Mean Antibody Titer Against Pertussis | pertussis （FHA） | 44.50 U/mL |
| ActHIB | Geometric Mean Antibody Titer Against Pertussis | pertussis （PT） | 203.58 U/mL |
| ActHIB | Geometric Mean Antibody Titer Against Pertussis | pertussis （FHA） | 68.75 U/mL |
Secondary
Geometric Mean Antibody Titer Against Pertussis
Time frame: 4 weeks after the booster dose (Visit 6)
Population: For antibody analysis at Visit 6, number of subjects 152.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MT-2301-Low | Geometric Mean Antibody Titer Against Pertussis | pertussis （PT） | 239.48 U/mL |
| MT-2301-Low | Geometric Mean Antibody Titer Against Pertussis | pertussis （FHA） | 124.84 U/mL |
| MT-2301-High | Geometric Mean Antibody Titer Against Pertussis | pertussis （PT） | 233.12 U/mL |
| MT-2301-High | Geometric Mean Antibody Titer Against Pertussis | pertussis （FHA） | 119.41 U/mL |
| ActHIB | Geometric Mean Antibody Titer Against Pertussis | pertussis （PT） | 262.73 U/mL |
| ActHIB | Geometric Mean Antibody Titer Against Pertussis | pertussis （FHA） | 158.85 U/mL |
Secondary
Geometric Mean Antibody Titer Against Tetanus Toxin
Time frame: 4 weeks after the booster dose (Visit 6)
Population: For antibody analysis at Visit 6, number of subjects 152.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| MT-2301-Low | Geometric Mean Antibody Titer Against Tetanus Toxin | 1.750 U/mL |
| MT-2301-High | Geometric Mean Antibody Titer Against Tetanus Toxin | 1.726 U/mL |
| ActHIB | Geometric Mean Antibody Titer Against Tetanus Toxin | 2.051 U/mL |
Secondary
Geometric Mean Antibody Titer Against Tetanus Toxin
Time frame: 4 weeks after the primary immunization (Visit 4)
Population: For antibody analysis at Visit 4, number of subjects 154.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| MT-2301-Low | Geometric Mean Antibody Titer Against Tetanus Toxin | 0.575 U/mL |
| MT-2301-High | Geometric Mean Antibody Titer Against Tetanus Toxin | 0.497 U/mL |
| ActHIB | Geometric Mean Antibody Titer Against Tetanus Toxin | 0.542 U/mL |
Secondary
Geometric Mean Antibody Titer of Anti-PRP Antibody
Time frame: 4 weeks after the booster dose (Visit 6)
Population: 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) .
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| MT-2301-Low | Geometric Mean Antibody Titer of Anti-PRP Antibody | 65.086 µg/mL |
| MT-2301-High | Geometric Mean Antibody Titer of Anti-PRP Antibody | 48.448 µg/mL |
| ActHIB | Geometric Mean Antibody Titer of Anti-PRP Antibody | 39.752 µg/mL |
Secondary
Geometric Mean Antibody Titer of Anti-PRP Antibody
Time frame: 4 weeks after the primary immunization (Visit 4)
Population: For antibody analysis at Visit 4, number of subjects 154.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| MT-2301-Low | Geometric Mean Antibody Titer of Anti-PRP Antibody | 21.120 µg/mL |
| MT-2301-High | Geometric Mean Antibody Titer of Anti-PRP Antibody | 13.724 µg/mL |
| ActHIB | Geometric Mean Antibody Titer of Anti-PRP Antibody | 7.374 µg/mL |