Immunization
Conditions
Keywords
Haemophilus influenza type b, Adsorbed Diphtheria-Purified Pertussis-Tetanus-Inactivate, poliovirus combined vaccine, Hib, DPT-IPV, Intramuscular
Brief summary
The purpose of this study is to evaluate the safety and efficacy of an intramuscular injection of BK1310 in healthy infants.
Interventions
BIOLOGICALDPT-IPV-Hib (Combined Vaccine)
0.5mL, intramuscular injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
Sponsors
The Research Foundation for Microbial Diseases of Osaka University
Tanabe Pharma Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Months to 43 Months
Healthy volunteers
Yes
Inclusion criteria
* Healthy infants aged ≥2 and \<43 months at the first vaccination of the study drug (recommended: ≥2 and \<7 months). Those who are applicable of the following conditions must be carefully observed before the enrollment: infants with known underlying disease such as cardiovascular disease, renal disease, hepatic disease, blood dyscrasia, respiratory disease or developmental disorder. Infants who developed fever within 2 days after any previous vaccination. Infants with history of convulsions. * Written informed consent is obtained from a legal guardian (parent)
Exclusion criteria
* With past diagnosis of immunodeficiency or currently under immunosuppressive treatment * Have close relatives (the third degree of kinship) diagnosed with congenital immunodeficiency * Possibility of anaphylaxis due to food or pharmaceuticals * With diagnosis of thrombocytopenia and/or coagulopathy or currently under treatment of the antiplatelet agents and/or anticoagulant agents. * With experience of Hib infection, diphtheria, pertussis, tetanus or acute poliomyelitis * With experience of Hib, diphteria, pertussis, tetanus or polio vaccination. * 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) * Participated in other studies within 12 weeks before obtaining consent * With the gestational age \<37 weeks or weighed less than 2500 grams at birth. * Considered to be not eligible by the principal investigators (sub-investigators) of the enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 4 weeks after the primary immunization (Visit 4) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 （PT） | 4 weeks after the primary immunization (Visit 4) | — |
| 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 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 | 4 weeks after the booster dose (Visit 6) | 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 |
| Geometric Mean Antibody Titer Against Pertussis （FHA） | 4 weeks after the primary immunization (Visit 4) | — |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 33 |
| Total | 33 |
Baseline characteristics
| Characteristic | BK1310 |
|---|---|
| Age, Customized >=2 and <3 months | 27 Participants |
| Age, Customized >=3 months | 6 Participants |
| Race/Ethnicity, Customized Asian (Japanese) | 33 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 33 |
| other Total, other adverse events | 33 / 33 |
| serious Total, serious adverse events | 2 / 33 |
Outcome results
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
Time frame: 4 weeks after the primary immunization (Visit 4)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BK1310 | 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 against anti-PRP with 1 μg/mL or higher | 97.0 percentage of participants |
| BK1310 | 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 against diphtheria toxin | 93.9 percentage of participants |
| BK1310 | 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 against pertussis （PT） | 100.0 percentage of participants |
| BK1310 | 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 against pertussis (FHA) | 97.0 percentage of participants |
| BK1310 | 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 against tetanus toxin | 100.0 percentage of participants |
| BK1310 | 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 against polio virus serotype 1 | 100.0 percentage of participants |
| BK1310 | 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 against polio virus serotype 2 | 100.0 percentage of participants |
| BK1310 | 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 against polio virus serotype 3 | 100.0 percentage of participants |
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
Time frame: 4 weeks after the booster dose (Visit 6)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BK1310 | 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 against diphtheria toxin | 100.0 percentage of participants |
| BK1310 | 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 against pertussis （PT） | 100.0 percentage of participants |
| BK1310 | 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 against pertussis （FHA） | 100.0 percentage of participants |
| BK1310 | 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 against tetanus toxin | 100.0 percentage of participants |
| BK1310 | 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 against polio virus serotype 1 | 100.0 percentage of participants |
| BK1310 | 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 against polio virus serotype 2 | 100.0 percentage of participants |
| BK1310 | 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 against polio virus serotype 3 | 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 primary immunization (Visit 4)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BK1310 | 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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BK1310 | 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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BK1310 | 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: Baseline and 4 weeks after the primary immunization (Visit 6)
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| BK1310 | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | Geometric mean antibody titer against polio virus serotype 1 | 1642.66 fold change |
| BK1310 | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | Geometric mean antibody titer against polio virus serotype 2 | 8910.01 fold change |
| BK1310 | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | Geometric mean antibody titer against polio virus serotype 3 | 5000.58 fold change |
Secondary
Fold Change in Geometric Mean Antibody Titer Against Polio Virus
Time frame: Baseline and 4 weeks after the primary immunization (Visit 4)
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| BK1310 | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | Geometric mean antibody titer against polio virus serotype 1 | 551.06 fold change |
| BK1310 | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | Geometric mean antibody titer against polio virus serotype 2 | 1510.29 fold change |
| BK1310 | Fold Change in Geometric Mean Antibody Titer Against Polio Virus | Geometric mean antibody titer against polio virus serotype 3 | 1290.16 fold change |
Secondary
Geometric Mean Antibody Titer Against Diphtheria Toxin
Time frame: 4 weeks after the primary immunization (Visit 4)
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| BK1310 | Geometric Mean Antibody Titer Against Diphtheria Toxin | 1.0818 IU/mL |
Secondary
Geometric Mean Antibody Titer Against Diphtheria Toxin
Time frame: 4 weeks after the booster dose (Visit 6)
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| BK1310 | Geometric Mean Antibody Titer Against Diphtheria Toxin | 9.6485 IU/mL |
Secondary
Geometric Mean Antibody Titer Against Pertussis （FHA）
Time frame: 4 weeks after the booster dose (Visit 6)
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| BK1310 | Geometric Mean Antibody Titer Against Pertussis （FHA） | 114.19 EU/mL |
Secondary
Geometric Mean Antibody Titer Against Pertussis （FHA）
Time frame: 4 weeks after the primary immunization (Visit 4)
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| BK1310 | Geometric Mean Antibody Titer Against Pertussis （FHA） | 53.64 EU/mL |
Secondary
Geometric Mean Antibody Titer Against Pertussis （PT）
Time frame: 4 weeks after the booster dose (Visit 6)
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| BK1310 | Geometric Mean Antibody Titer Against Pertussis （PT） | 173.17 EU/mL |
Secondary
Geometric Mean Antibody Titer Against Pertussis （PT）
Time frame: 4 weeks after the primary immunization (Visit 4)
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| BK1310 | Geometric Mean Antibody Titer Against Pertussis （PT） | 128.03 EU/mL |
Secondary
Geometric Mean Antibody Titer Against Tetanus Toxin
Time frame: 4 weeks after the primary immunization (Visit 4)
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| BK1310 | Geometric Mean Antibody Titer Against Tetanus Toxin | 0.3068 IU/mL |
Secondary
Geometric Mean Antibody Titer Against Tetanus Toxin
Time frame: 4 weeks after the booster dose (Visit 6)
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| BK1310 | Geometric Mean Antibody Titer Against Tetanus Toxin | 1.8293 IU/mL |
Secondary
Geometric Mean Antibody Titer of Anti-PRP Antibody
Time frame: 4 weeks after the booster dose (Visit 6)
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| BK1310 | Geometric Mean Antibody Titer of Anti-PRP Antibody | 28.509 µg/mL |
Secondary
Geometric Mean Antibody Titer of Anti-PRP Antibody
Time frame: 4 weeks after the primary immunization (Visit 4)
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| BK1310 | Geometric Mean Antibody Titer of Anti-PRP Antibody | 13.522 µg/mL |